[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hemorrhage\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hemorrhage":27},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,28,0,25,[9,41,76,111,143,179,216,249,274,302,332,360,393,419,448,480,511,537,565,586,612,641,663,696,726],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100567176","phase-3-a-study-to-compare-the-efficacy-and-safety-of-tachosil-and-surgicel-original-as-an-adjunct-to-control-mild-to-moderate-soft-tissue-bleeding-during-surgery-100567176",false,"NCT06664775","A Study to Compare the Efficacy and Safety of TachoSil and Surgicel Original as an Adjunct to Control Mild to Moderate Soft Tissue Bleeding During Surgery","An Open Label, Prospective, Randomized, Parallel Groups, Multicenter Study to Compare the Efficacy and Safety of TachoSil® Versus Surgicel™ Original (Oxidized Regenerated Cellulose) as an Adjunct to Control Mild to Moderate Soft Tissue Bleeding During Surgery.","Inclusion Criteria:\n\n1. Elective open abdominal, retroperitoneal, pelvic, or thoracic surgery. Elective transplant surgery except for liver or heart transplants is included.\n2. The participant has a need for secondary hemostatic study intervention at the TBS with mild to moderate bleeding Grade 1 and Grade 2 according to the VIBe Scale.\n3. Presence of an appropriate mild to moderate bleeding soft tissue TBS identified intra-operatively by the surgeon.\n4. The TBS size \\\u003C 21 cm2\u002F3.3 in2.\n5. Ability to firmly press study intervention at TBS until 3 minutes after randomization.\n\nExclusion Criteria:\n\n1. Participants undergoing cardiovascular, hepatic, and laparoscopic and robotic surgeries.\n2. Congenital or acquired disorders of coagulation.\n3. Diseases requiring constant use of any anticoagulant drugs that cannot be safely washed out prior to randomization.\n4. Screening Hemoglobin \\\u003C 9 mg\u002FdL, platelets \\\u003C 75 × 103\u002FµL, and\u002For international normalized ratio (INR) \\> 1.5.\n5. Acute major bleeding during surgery.\n6. Participant with TBS in an actively infected field.\n7. Target bleeding site is from large defects in arteries or veins where the injured vascular wall requires repair with maintenance of vessel patency.\n8. Target bleeding site with major arterial bleeding requiring suture or mechanical ligation.\n9. Bleeding site is in, around, or in proximity to foramina in bone, or areas of bony confine.\n10. Participants with Grade '0', '3', and '4' bleeding at TBS according to VIBe Scale.","ALL","1 Month",{"count":20,"type":21},116,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","The purpose of this clinical study is to assess the efficacy and safety of TachoSil compared to the widely known and used for \\> 60 years local hemostatic product Surgicel Original as an adjunct to control mild to moderate soft tissue bleeding during surgery.",[27],"Hemorrhage","RECRUITING","2026-06-26",{"date":31,"type":32},"2026-06-30","ACTUAL",{"date":34,"type":32},"2025-04-02",{"date":36,"type":21},"2026-12-31",{"name":38,"class":39},"Corza Medical GmbH","INDUSTRY",9,{"id":42,"slug":43,"hasResults":12,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":12,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":53,"conditions":54,"keywords":58,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":75},"100639802","platelets-and-extracorporeal-membrane-oxygenation-veno-venous-100639802","NCT07580469","Platelets and Extracorporeal Membrane Oxygenation Veno-venous","Study of PLATelet Functions and Risk Factors for Hemorrhagic Complications in Patients on Extracorporeal Membrane Oxygenation Veno-venous: Prospective Monocentric Cohort","PLAT-VV-ECMO","Inclusion Criteria:\n\n* Adults aged ≥ 18 years\n* No objection to participation in the study, obtained from a relative or trusted person; if no relative is available, inclusion under emergency procedure (pending patient or relative non-opposition)\n* Patients requiring admission to the general intensive care unit of Hôpital Rangueil for venovenous ECMO\n* Equipped with an arterial catheter for blood sampling\n* Ability to undergo the 4 blood draws relevant to the study\n* Receiving therapeutic anticoagulation with unfractionated heparin\n* Enrolled in a social security program or equivalent\n* No measures for Limitation and Withdrawal of Therapy have been implemented\n\nExclusion Criteria:\n\n* Minors\n* Patients under court-appointed guardianship or conservatorship\n* Pregnant or breastfeeding women\n* Hematological disease (leukemia, lymphoma) or constitutional thrombocytopenia\n* Platelet transfusion within 7 days prior to enrollment\n* Indication for immediate emergency ECMO preventing blood sampling before placement\n* Post-cardiotomy\n* Patient on antiplatelet therapy\n* Severe thrombocytopenia \\\u003C50 G\u002FL\n* Other invasive mechanical support such as Impella®, intra-aortic balloon pump, or Left Ventricular Assist Device (LVAD)","18 Years",{"count":51,"type":21},40,"OBSERVATIONAL","In severe lung or heart disease, ExtraCorporeal Membrane Oxygenation (ECMO) may be used temporarily and can be responsible for major haemorrhagic complications. Thrombocytopenia and possibly thrombopathy promote bleeding. The primary objective is to characterize platelet dysfunction by aggregometry tests over time. Secondarily, investigators seek a correlation between haemorrhagic complications at day 10 and markers of platelet action and dysfunction; also, with the level of anticoagulation and inflammation by biomarkers.",[55,27,56,57],"Extracorporeal Membrane Oxygenation Complication","Blood Platelet Disorder","Thrombosis",[59,60,61,62,63],"VV-ECMO","Platelets","Thrombopathy","thrombo-haemorrhagic complications","thrombo-inflammation","NOT_YET_RECRUITING","2026-06-24",{"date":67,"type":32},"2026-06-29",{"date":69,"type":21},"2026-09",{"date":71,"type":21},"2028-12-31",{"name":73,"class":74},"University Hospital, Toulouse","OTHER",1,{"id":77,"slug":78,"hasResults":12,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":12,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":22,"phases":86,"briefSummary":88,"conditions":89,"keywords":99,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":75},"100644087","efficacy-and-safety-of-antihypertensive-treatment-with-mobile-stroke-units-in-ultra-early-intracerebral-hemorrhage-100644087","NCT07665827","Efficacy and Safety of Antihypertensive Treatment With Mobile Stroke Units in Ultra-Early Intracerebral Hemorrhage","Efficacy and Safety of Antihypertensive Treatment With Mobile Stroke Units in Ultra-Early Intracerebral Hemorrhage: A Multicenter, Prospective, Cluster-Randomized, Open-Label, Blinded-Endpoint Clinical Trial","MSU-ICH","Inclusion Criteria:\n\n1. History and physical\u002Fneurological examination consistent with acute stroke.\n2. Age ≥18 years;\n3. Time from symptom onset to enrollment \\\u003C3 hours (onset defined as last known normal).\n4. Systolic blood pressure ≥150 mmHg and ≤220 mmHg;\n5. Pre-stroke modified Rankin Scale (mRS) score ≤2;\n6. Informed consent obtained from the subject or a legally authorized representative.\n\nExclusion Criteria:\n\n1. Glasgow Coma Scale (GCS) score ≤5.\n2. Contraindications to intensive blood pressure lowering, including severe arterial stenosis or high-grade stenotic valvular heart disease.\n3. Malignant disease or other serious primary illness with a life expectancy of \\\u003C3 months.\n4. Current participation in another interventional randomized clinical trial.",{"count":85,"type":21},706,[87],"NA","MSU-ICH is a prospective, multicenter, Week-wise-randomized, open-label, blinded-endpoint (PROBE) clinical trial comparing ultra-early prehospital blood pressure lowering delivered by a Mobile Stroke Unit (MSU) with standard Emergency Medical Services (EMS) in patients with spontaneous intracerebral hemorrhage.",[90,91,92,93,27,94,95,96,97,98],"Nervous System Diseases","Cerebrovascular Disorders","Cardiovascular Diseases","Vascular Diseases","Intracranial Hemorrhages","Cerebral Hemorrhage","Cerebral Hemorrhage, Hypertensive","Stroke","Hemorrhagic Stroke, Intracerebral",[100,101,102],"intracerebral hemorrhage","mobile stroke units","Intensive blood pressure lowering","2026-06-18",{"date":65,"type":32},{"date":106,"type":21},"2026-06",{"date":108,"type":21},"2028-07",{"name":110,"class":74},"Xuanwu Hospital, Beijing",{"id":112,"slug":113,"hasResults":12,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":117,"eligibilityCriteria":118,"healthyVolunteers":12,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":119,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":121,"conditions":122,"keywords":126,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":142},"100609715","cryo-first-effectiveness-of-intercept-fibrinogen-complex-ifc-for-trauma-associated-hemorrhage-100609715","NCT07218185","Cryo-FIRST: Effectiveness of INTERCEPT Fibrinogen Complex (IFC) for Trauma-Associated Hemorrhage","Cryo-FIRST: Cryoprecipitate For Immediate Resuscitation in Severe Trauma: Effectiveness of Pathogen Reduced Cryoprecipitated Fibrinogen Complex (INTERCEPT Fibrinogen Complex, IFC) for Treatment of Trauma Associated Hemorrhage","CRYO-FIRST","Inclusion Criteria:\n\n* Traumatic injury\n* Age ≥18 years or estimated weight ≥50 kg, if age unknown\n* Presenting to a participating trauma center ≤1 hour from estimated time of injury\n* Functional hypofibrinogenemia upon arrival to the trauma center as measured by point-of-care testing (Quantra®) with FCS \\\u003C1.6 hPa\n* Hemorrhagic shock, defined as:\n\n  1. Initiation of transfusion of any uncrossmatched blood product;\n  2. Evidence of active hemorrhage as judged by the attending trauma surgeon; and\n  3. Initiation of the participating trauma center's massive transfusion protocol (MTP)\n* IFC administration is clinically indicated per the treating physician\n* IFC is available at the time of enrollment\n\nExclusion Criteria:\n\n* Suspected isolated severe brain or spinal cord injury\n* Isolated drowning or hanging\n* Burns \\>20% total body surface area (TBSA)\n* Known pregnancy\n* Admitted from a correctional facility\n* Known do not resuscitate (DNR) order\n* Traumatic arrest \\>5 minutes, defined as continuous CPR \\>5 minutes at any time point prior to enrollment in the study\n* Isolated fall from standing\n* Emergency Department (ED) thoracotomy",{"count":120,"type":21},320,"The objective of this multicenter, single-arm, observational study is to determine the feasibility and effectiveness of early administration of FDA-approved, pre-thawed Pathogen Reduced Cryoprecipitated Fibrinogen Complex (INTERCEPT Fibrinogen Complex, IFC) in trauma patients with hemorrhagic shock (HS) and functional hypofibrinogenemia. This study will determine whether rapid point-of-care testing for functional hypofibrinogenemia and availability of a shelf-stable fibrinogen complex (IFC) results in shorter time to administration of fibrinogen replacement and correction of functional hypofibrinogenemia, as compared with historical controls and published literature using conventional cryoprecipitate-AHF (CRYO-AHF).\n\nThis study aims to:\n\n* Demonstrate the feasibility and response to early administration of pre-thawed IFC when ordered during initial resuscitation of severely injured patients with HS and functional hypofibrinogenemia.\n* Assess the effectiveness of early administration of pre-thawed IFC on correction of functional hypofibrinogenemia and on proximate process measures of resuscitation, including time to hemostasis, time to completion of resuscitation, and total volume of resuscitation.\n* Assess clinical outcomes in severely injured patients with HS and functional hypofibrinogenemia receiving early administration of pre-thawed IFC.",[123,27,124,125],"Hypofibrinogenemia","Trauma Associated Hemorrhage","Hemorrhagic Shock",[127,27,128,129,130,131,125,132],"Fibrinogen","Trauma","Resuscitation","INTERCEPT Fibrinogen Complex","Pathogen Reduced Cryoprecipitated Fibrinogen Complex","Quantra","2026-06-16",{"date":135,"type":32},"2026-06-17",{"date":137,"type":21},"2026-07",{"date":139,"type":21},"2028-08",{"name":141,"class":39},"Cerus Corporation",4,{"id":144,"slug":145,"hasResults":12,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":4,"eligibilityCriteria":149,"healthyVolunteers":150,"sex":151,"minAge":49,"maxAge":4,"enrollmentInfo":152,"targetDuration":4,"studyType":22,"phases":154,"briefSummary":156,"conditions":157,"keywords":162,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":178},"100579121","phase-4-tranexamic-acid-for-second-trimester-dilation-and-evacuation-and-bleeding-outcomes-100579121","NCT06820177","Tranexamic Acid for Second Trimester Dilation and Evacuation and Bleeding Outcomes","Prophylactic Tranexamic Acid for Second Trimester Dilation and Evacuation and Bleeding Outcomes: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Able to understand and sign informed consent\n* Speaks English or Spanish language,\n* Requesting pregnancy termination or procedural management of fetal demise - Intrauterine pregnancy, 18 weeks 0 days and 24 weeks and 0 days gestation\n\nExclusion Criteria:\n\n* History of or current thromboembolic event (deep vein thrombosis, stroke, pulmonary embolism)\n* History of coagulopathy\n* Anticoagulant use in the preceding five days\n* Severe renal impairment\n* Chorioamnionitis or sepsis\n* Suspected placenta accreta spectrum\n* Prophylactic uterotonics other than oxytocin given (or planned to be given) at the start of the D\\&E\n* Known allergic reaction or hypersensitivity to TXA",true,"FEMALE",{"count":153,"type":21},276,[155],"PHASE4","Although procedural abortion in the second trimester is extremely safe, hemorrhage is one of the leading causes of morbidity and mortality. Tranexamic acid (TXA) is used commonly in obstetrics to prevent or manage intrapartum or postpartum hemorrhage and has been associated with decreased mortality and decreased blood loss at the time of birth. Some guidelines are recommending the use of TXA for both the prevention and management of bleeding for abortion care. However, there are currently no published studies assessing the association between TXA and bleeding outcomes for abortion procedures. This study will involve a randomized, placebo-controlled trial of pregnant patients aged 18 and older desiring dilation and evacuation (D\\&E) for abortion or fetal demise at 18-24 weeks gestation. The primary aim is to determine whether prophylactic TXA has an effect on the need for additional interventions to control bleeding at the time of D\\&E. The secondary aim is to determine whether prophylactic TXA has an effect on the mean quantitative procedural blood loss.",[158,159,27,160,161],"Abortion","Dilation and Evacuation","Prophylactic Tranexamic Acid Use","Blood Loss",[163,164,165,166,167,168],"abortion","dilation and evacuation","TXA","hemorrhage","Tranexamic acid","D&E","2026-06-12",{"date":171,"type":32},"2026-06-15",{"date":173,"type":32},"2025-04-22",{"date":175,"type":21},"2027-05",{"name":177,"class":74},"University of California, San Diego",3,{"id":180,"slug":181,"hasResults":12,"nctId":182,"briefTitle":183,"officialTitle":183,"acronym":4,"eligibilityCriteria":184,"healthyVolunteers":12,"sex":17,"minAge":185,"maxAge":4,"enrollmentInfo":186,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":188,"conditions":189,"keywords":199,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":211,"completionDateStruct":212,"leadSponsor":214,"locationsCount":4},"100642579","case-specific-health-care-professional-clinical-survey-for-concerto-versa-detachable-coils-100642579","NCT07639853","Case-Specific Health Care Professional Clinical Survey for Concerto Versa™ Detachable Coils","Inclusion Criteria:\n\n1. Patient treated with Concerto Versa™ Detachable Coil is age ≥ 22 years at the time of procedure.\n2. Use of Concerto Versa™ Detachable Coil in accordance with the device labeling.\n3. Reporting of case within 72 hours of index procedure.","22 Years",{"count":187,"type":21},30,"The purpose of the Case-Specific Health Care Professional (HCP) Clinical Survey for Concerto Versa™ Detachable Coils, also known as the Concerto Versa HCP Clinical Assessment, is to collect early clinical data from HCPs to assess clinical safety and performance of the Concerto Versa™ Detachable Coils, when used in accordance with approved device labeling per the Instructions for Use (IFU). Data collected will generate clinical evidence to quantitatively assess clinical safety and device performance for the purpose of obtaining European Union Medical Device Regulation (EU MDR) approval.",[190,191,192,193,194,195,196,197,198,27],"Arteriovenous Malformation","Gastrointestinal Bleed","Gastric Varices","Hemorrhoid","Pelvic Venous Disorders","Peripheral Aneurysms","Portal Vein Embolization","Type II Endoleak","Varicocele",[200,201,202,203,204,205,206,207,208],"Peripheral Vascular Disease","Vascular Disease","Arterial Embolization","Arteriovenous Embolization","Venous Embolization","Embolization Coils","Peripheral Embolization Coils","Peripheral Arterial Disease","Embolization","2026-06-11",{"date":171,"type":32},{"date":137,"type":21},{"date":213,"type":21},"2026-11",{"name":215,"class":39},"Medtronic Endovascular",{"id":217,"slug":218,"hasResults":12,"nctId":219,"briefTitle":220,"officialTitle":221,"acronym":222,"eligibilityCriteria":223,"healthyVolunteers":12,"sex":17,"minAge":224,"maxAge":4,"enrollmentInfo":225,"targetDuration":4,"studyType":22,"phases":227,"briefSummary":228,"conditions":229,"keywords":235,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":240,"lastUpdatePostDateStruct":241,"startDateStruct":243,"completionDateStruct":245,"leadSponsor":247,"locationsCount":75},"100626880","catheter-ablation-plus-laao-versus-anticoagulation-in-frail-elderly-patients-with-atrial-fibrillation-100626880","NCT07441382","Catheter Ablation Plus LAAO Versus Anticoagulation in Frail Elderly Patients With Atrial Fibrillation","Randomized Controlled Trial - Catheter Ablation Combined With Left Atrial Appendage Occlusion Versus Catheter Ablation Combined With Oral Anticoagulation for Elderly Frailty Patients With Atrial Fibrillation: Comparison of Efficacy and Safety","CLEAR-AF","Inclusion Criteria: (1) Age ≥ 75 years. (2) Confirmed diagnosis of non-valvular atrial fibrillation (paroxysmal or persistent). (3) CHA2DS2-VASc score ≥ 3 (high risk of stroke) . (4) Procedure-related criteria: Sequential Group: Participants who have received catheter ablation for non-valvular AF within 90 to 180 days prior to randomization. One-stop Group: Participants who are scheduled to undergo clinically indicated catheter ablation within 10 days after randomization. (5) Judged by the investigator to be able to tolerate the defined antithrombotic drug regimen. (6) Suitable to undergo Transesophageal Echocardiography (TEE) or Pulmonary Vein Computed Tomography (CT). (7) Able and willing to sign the written informed consent form. (8) Willing to return for all scheduled follow-up visits and examinations. Exclusion Criteria: (1) Presence of thrombus in the left atrium or left atrial appendage identified on preoperative imaging (echocardiogram, pulmonary vein CT, etc). (2) Major bleeding event (per ISTH definition) within 14 days prior to randomization. Participants must be excluded if clinical sequelae persist or if interventions for the bleeding source are planned\u002Fpending, regardless of the time elapsed since the event. (3) Requirement for long-term oral anticoagulation (OAC) for reasons other than stroke risk reduction in AF (e.g., underlying hypercoagulable state) that would prevent OAC discontinuation post-device implantation. (4) Any cardiac or major non-cardiac intervention\u002Fsurgery (excluding AF ablation and cardioversion) performed within 30 days prior to, or scheduled within 60 days after randomization. This includes but is not limited to Percutaneous Coronary Intervention (PCI) or other cardiac ablations. (5) Life expectancy \\\u003C 2 years, malignancy, infectious endocarditis, uncontrolled infection, or physiological evidence of cardiac tamponade. (6) Clinical Frailty Scale (CFS) score of 1-3 (not frail) or 7-9 (severely frail\u002Fterminally ill). (7) Deemed unsuitable for long-term anticoagulation and\u002For antiplatelet therapy by the investigator due to bleeding risk, allergies, or other reasons. (8) Current participation in another clinical trial that interferes with this study, excluding mandatory government or purely observational registries. (9) Stroke or transient ischemic attack (TIA) within 60 days prior to randomization. (10) Documented myocardial infarction (NSTEMI or STEMI) within 90 days prior to randomization, regardless of intervention. (11) History of atrial septal defect (ASD) repair or presence of an ASD\u002FPatent Foramen Ovale (PFO) occluder. (12) Presence of a mechanical prosthetic valve in any position. (13) Participants of childbearing potential who are pregnant or planning pregnancy during the study period. (14) Medical or anatomical contraindications to percutaneous catheter-based interventions. (15) Documented NYHA Class IV heart failure. (16) History of surgical left atrial appendage (LAA) closure.\n\nTransthoracic Echocardiography (TTE) Specific Exclusions: (1) Low LVEF: Left ventricular ejection fraction (LVEF) \\\u003C 30%. (2) Presence of pericardial effusion with a circumferential echo-free space \\> 5mm. (3) Presence of high-risk PFO associated with an atrial septal aneurysm (ASA) with an excursion or length \\> 15mm. (4) Presence of high-risk PFO with a large shunt (defined as appearance of microbubbles within 3 cardiac cycles and\u002For a substantial count of microbubbles). (5) Presence of moderate or severe mitral stenosis (mitral valve area \\\u003C 1.5 cm2).","75 Years",{"count":226,"type":21},200,[87],"Atrial fibrillation (AF) is the most common arrhythmia, significantly increasing the risk of stroke, heart failure, hospitalization and death in patients. Studies have shown that standardized anticoagulation can effectively reduce the risk of stroke by 64% and the risk of death by 26% in AF patients. Therefore, both European and American guidelines recommend standardized oral anticoagulation (OAC) as an important treatment strategy for stroke prevention in AF patients. However, the use of OAC may also increase the risk of bleeding in patients. Results from large AF anticoagulation randomized trials show that the annual risk of anticoagulation-related bleeding mortality is 2% to 3%. Therefore, according to the guidelines recommendations, assessing the bleeding risk is necessary in patients with anticoagulant indications.\n\nPercutaneous left atrial appendage occlusion (LAAO) is a device-based therapy that aims to prevent ischemic stroke in patients with AF. For patients with contraindications to long-term anticoagulation therapy, LAAO can be considered as an alternative strategy to oral anticoagulation (Class II B recommendation) to prevent ischemic stroke and thromboembolism. Multiple studies have shown that LAAO is non-inferior to warfarin and novel oral anticoagulants in stroke prevention for non-valvular AF patients. Age is not only a risk factor for stroke but also an important risk factor for bleeding. In the elderly population, especially those with frailty, the risk factors for both stroke and bleeding are often increased. Currently, there is insufficient evidence to support the use of OAC in frail elderly patients with relative anticoagulant contraindications. Therefore, elderly AF patients may be one of the potential beneficiary groups for LAAO. However, most previous clinical studies on LAAO were based on small sample sizes to analyze their safety and efficacy, and clinical data on the safety and efficacy of LAAO in this high-risk population of elderly AF patients are still limited. To address this, the study aims to conduct a multicenter randomized controlled trial to compare the efficacy and safety of catheter ablation combined with LAAO versus catheter ablation combined with OAC in elderly AF patients with high bleeding risk, filling the gap in this research area.\n\nTo address these limitations, this multicenter randomized controlled trial is designed to evaluate the efficacy and safety of catheter ablation combined with LAAO versus catheter ablation combined with OAC in elderly AF patients at high risk for bleeding. The primary objective of the study is to compare the 12-month incidence and time-to-occurrence of the composite clinical endpoint. This endpoint includes stroke\u002FTIA, systemic embolism, ISTH-defined major bleeding. By establishing these metrics within the first year, the study aims to fill the current void in clinical evidence and provide a standardized treatment strategy for high-risk elderly patients. In addition to the primary endpoints, the study will conduct a comprehensive long-term evaluation extending to 24 months post-procedure to assess the durability of both treatment strategies. Secondary objectives include the assessment of perioperative safety, specifically focusing on serious intraoperative complications and major adverse events occurring within the first seven days after the LAAO procedure. The trial will also measure long-term rhythm control by tracking the rate of freedom from AF recurrence at the one-year and two-year marks. Furthermore, the study seeks to verify the hypothesized superiority of the ablation-plus-LAAO strategy in reducing the specific burden of anticoagulation-related major bleeding and stroke.\n\nBeyond clinical safety and efficacy, the trial will analyze the practical aspects of the two interventions, including procedural success rates, operation duration, fluoroscopy time, and the total duration of hospitalization. A critical component of the research involves identifying specific risk factors associated with complications, with a specialized focus on how frailty scores influence procedural tolerance and long-term prognosis. The study will further explore how different types of AF respond to the LAAO strategy and assess the impact of each treatment on non-major bleeding events. Ultimately, the trial aims to determine which strategy offers a superior improvement in the overall quality of life for elderly patients, thereby optimizing future clinical guidelines.",[230,97,27,231,232,233,234],"Atrial Fibrillation (AF)","Frailty","Atrial Appendage","Catheter Ablation","Anticoagulants",[236,237,97,27,234,231,238,239,233],"Atrial Fibrillation","Left Atrial Appendage Closure","Aged","Randomized Controlled Trial","2026-06-05",{"date":242,"type":32},"2026-06-08",{"date":244,"type":32},"2026-03-24",{"date":246,"type":21},"2028-03-01",{"name":248,"class":74},"Guangdong Provincial People's Hospital",{"id":250,"slug":251,"hasResults":12,"nctId":252,"briefTitle":253,"officialTitle":254,"acronym":4,"eligibilityCriteria":255,"healthyVolunteers":12,"sex":17,"minAge":185,"maxAge":4,"enrollmentInfo":256,"targetDuration":4,"studyType":22,"phases":258,"briefSummary":259,"conditions":260,"keywords":264,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":266,"lastUpdatePostDateStruct":267,"startDateStruct":269,"completionDateStruct":271,"leadSponsor":272,"locationsCount":273},"100573170","onyx-liquid-embolic-ide-clinical-study-100573170","NCT06742801","Onyx™ Liquid Embolic IDE Clinical Study","PELE IDE Clinical Study, Peripheral Onyx™ Liquid Embolic Safety and Effectiveness of The Onyx™ LES for Embolization of Arterial Hemorrhage in the Peripheral Vasculature","Inclusion Criteria:\n\n1. Patient is ≥ 22 years old.\n2. Active arterial bleeding in the peripheral vasculature confirmed by radiologic and\u002For endoscopic imaging and deemed suitable for embolization treatment by the investigator.\n\n   In this study, peripheral vasculature is defined as outside the brain and heart.\n3. Patient or legally authorized representative (LAR) is able to provide written consent to participate in the study.\n4. Life expectancy of \\>30 days, in the opinion of the investigator at the time of enrollment.\n5. Target treatment area is free from prior embolization treatment.\n\nExclusion Criteria:\n\n1. Pregnant or breastfeeding.\n2. Symptoms of active infection.\n3. Patient is known to be participating in the study of an investigational drug, biologic, or device.\n4. Contrast allergy or other contraindication to angiography, CT, or catheterization, including contrast sensitivity that cannot be adequately treated prior to index procedure.\n5. Known allergy to components of Onyx™.\n6. Target vasculature unsuitable for the delivery of Onyx™ based upon physician assessment.\n7. More than 4 target lesions will require embolization, in the investigator's opinion after imaging-based assessment.",{"count":257,"type":21},119,[87],"The purpose of this study is to evaluate the safety and effectiveness of Onyx™ LES in the treatment of subjects with active arterial bleeding in the peripheral vasculature outside of the heart and brain.",[261,128,262,263,27],"Peripheral Arterial Hemorrhage","GI Bleed","Ulcer",[261,265],"Embolization treatment","2026-06-02",{"date":268,"type":32},"2026-06-03",{"date":270,"type":32},"2025-05-09",{"date":175,"type":21},{"name":215,"class":39},18,{"id":275,"slug":276,"hasResults":12,"nctId":277,"briefTitle":278,"officialTitle":278,"acronym":279,"eligibilityCriteria":280,"healthyVolunteers":12,"sex":17,"minAge":49,"maxAge":281,"enrollmentInfo":282,"targetDuration":4,"studyType":22,"phases":284,"briefSummary":286,"conditions":287,"keywords":288,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":293,"lastUpdatePostDateStruct":294,"startDateStruct":295,"completionDateStruct":297,"leadSponsor":299,"locationsCount":301},"100512891","phase-2-calcium-and-vasopressin-following-injury-early-resuscitation-cavalier-trial-100512891","NCT05958342","CAlcium and VAsopressin Following Injury Early Resuscitation (CAVALIER) Trial","CAVALIER","Inclusion Criteria:\n\nPrehospital Phase:\n\nInjured patients at risk of hemorrhagic shock being transported from scene or referral hospital to a participating CAVALIER trial site who meet the following criteria:\n\n1A. Systolic blood pressure ≤ 90mmHg and tachycardia (HR ≥ 108) at scene, at outside hospital, or during anticipated transport to a participating CAVALIER trial site\n\nOR\n\n1B. Systolic blood pressure ≤ 70mmHg at scene, at outside hospital, or during anticipated transport to a participating CAVALIER trial site\n\nEarly In-Hospital Phase:\n\nInjured patients at a participating CAVALIER trial site at risk of hemorrhagic shock who meet the following criteria:\n\n1A. Systolic blood pressure ≤ 90mmHg and tachycardia (HR ≥ 108) at scene, at outside hospital, during transport, or in emergency department of a participating CAVALIER trial site\n\nOR\n\n1B. Systolic blood pressure ≤ 70mmHg at scene, at outside hospital, during transport, or in emergency department of a participating CAVALIER trial site\n\nAND\n\n2.Blood\u002Fblood component transfusion initiated in prehospital setting or deemed clinically indicated within 60 minutes of arrival at the enrolling trauma center\n\nAND 3. Clinical team deems Operating Room for major hemorrhage control procedure (e.g., laparotomy, thoracotomy, vascular exploration or extremity amputation) indicated within 60 minutes of arrival at the enrolling trauma center\n\nAND\n\n4\\. Anticipated admission to intensive care unit (ICU)\n\nExclusion Criteria:\n\nPrehospital Phase\n\n1. Wearing NO CAVALIER opt-out bracelet\n2. Age \\> 90 or \\\u003C 18 years of age\n3. Isolated fall from standing injury mechanism\n4. Known prisoner\n5. Known pregnancy\n6. Traumatic arrest with \\> 5 minutes of CPR without return of vital signs\n7. Brain matter exposed or penetrating brain injury\n8. Isolated drowning or hanging victims\n9. Objection to study voiced by subject or family member at the scene or at the trauma center\n10. Inability to obtain IV\u002FIO access\n\nEarly In-Hospital Phase:\n\n1. Wearing NO CAVALIER opt-out bracelet\n2. Age \\> 90 or \\\u003C 18 years of age\n3. Isolated fall from standing injury mechanism\n4. Known prisoner\n5. Known pregnancy\n6. Traumatic arrest with \\> 5 minutes of CPR without return of vital signs\n7. Brain matter exposed or penetrating brain injury\n8. Isolated drowning or hanging victims\n9. Objection to study voiced by subject or family member at the scene or at the trauma center\n10. Inability to obtain IV access","90 Years",{"count":283,"type":21},1050,[285],"PHASE2","The CAlcium and VAsopressin following Injury Early Resuscitation (CAVALIER) Trial is a proposed 4 year, double-blind, mutli-center, prehospital and early in hospital phase randomized trial designed to determine the efficacy and safety of prehospital calcium and early in hospital vasopressin in patients at risk of hemorrhagic shock.",[128,27],[289,290,291,292],"hemorrhagic shock","trauma","calcium gluconate","vasopressin","2026-06-01",{"date":268,"type":32},{"date":296,"type":32},"2024-06-30",{"date":298,"type":21},"2028-03",{"name":300,"class":74},"Jason Sperry",15,{"id":303,"slug":304,"hasResults":12,"nctId":305,"briefTitle":306,"officialTitle":306,"acronym":307,"eligibilityCriteria":308,"healthyVolunteers":12,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":309,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":311,"conditions":312,"keywords":317,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":322,"lastUpdatePostDateStruct":323,"startDateStruct":325,"completionDateStruct":327,"leadSponsor":329,"locationsCount":75},"100639683","clot-less---closure-tailored-less-antithrombotic-strategy-after-laac-for-stroke-prevention-100639683","NCT07575867","CLOT-LESS - CLOsure Tailored: LEss Antithrombotic Strategy After LAAC for Stroke Prevention","CLOT-LESS","Inclusion Criteria:\n\n* Age ≥18 years;\n* Documented nonvalvular AF (≥30 seconds on ECG within previous 12 months);\n* CHA2DS2-VASc score ≥3 for women and ≥2 for men;\n* Signed informed consent to participate in the study;\n\nExclusion Criteria:\n\n* Active indication for anticoagulation OTHER than atrial fibrillation at the time of enrollment and\u002For the predicted\u002Funpredicted occurrence of such indications during the entire study period (e.g., mechanical valve, acute VTE, recent PE requiring \\>3 months anticoagulation);\n* Inability to tolerate at least 3 months of apixaban therapy (for LAAC arm);\n* Indications for antiplatelet therapy or therapy with P2Y12 inhibitors at the time of inclusion and\u002For the predicted\u002Funpredicted occurrence of such indications during the entire study period;\n* The presence of mechanical prosthetic heart valves, mitral stenosis of severe or moderate degree;\n* Active DVT requiring anticoagulation;\n* Congenital or acquired haemostasis disorders, rheumatic heart disease or recurrent deep vein thrombosis;\n* Left ventricular ejection fraction (LVEF) \\\u003C 30%;\n* Glomerular filtration rate (GFR) \\\u003C 30 ml\u002Fmin (stage IV or V chronic kidney disease) or dialysis patient;\n* Severe liver failure, including cirrhosis and Child-Pugh Class C\u002FD;\n* NYHA class IV congestive heart failure;\n* The patient had a myocardial infarction - MI with or without ST segment elevation (STEMI, NSTEMI) with or without intervention, within 30 days before LAAC;\n* The patient had a stroke (of any cause, ischemic or hemorrhagic) within 30 days before LAAC;\n* Intracardiac thrombus before LAAC;\n* Major bleeding according to BARC criteria (type 3 and higher) within 30 days before LAAC or before randomization;\n* Amyloid cardiomyopathy;\n* Platelet count \\\u003C 100,000 x 109\u002Fl;\n* The patient participates in another study, with the exception of observational studies without therapeutic interventions;\n* Pregnant or breast-feeding patients, patients planning pregnancy during the study period;\n* The LAAC procedure was unsuccessful or interrupted for technical reasons;\n* PDL (peridevice leak) ≥ 3 mm;\n* Contraindications for one of the treatment regimens prescribed by the study protocol (including allergic reactions);\n* Planned cardiac or non-cardiac surgical procedure within 30 days before or 90 days after LAAC. Minor procedures not requiring discontinuation of antithrombotic therapy are permitted (e.g., cardioversion, catheter ablation, cataract surgery);\n* The patient has a heart tumor, active infection, signs of physiological tamponade;\n* The documented life expectancy of the patient is less than 12 months;",{"count":310,"type":21},464,"This is a prospective, non-randomized, observational cohort study conducted at the FSBI \"NMRC TPM\" of the Ministry of Healthcare of the Russian Federation. Left atrial appendage closure (LAAC) has been shown to be non-inferior to oral anticoagulation for preventing cardioembolic events in patients with atrial fibrillation. However, the optimal post-procedural antithrombotic regimen following LAAC remains unclear, with no consensus on evidence-based therapy. Given current trends in cardiology favoring reduced-intensity antithrombotic strategies, this study aims to contribute to the evidence base by evaluating whether LAAC followed by reduced-dose apixaban (2.5 mg BID) for 3 months with subsequent complete withdrawal of antithrombotic therapy is superior to long-term standard-dose DOAC therapy in patients with non-valvular atrial fibrillation.",[236,313,237,27,314,315,316],"Stroke Prevention in Patients With Atrial Fibrillation","Anticoagulants \u002F Administration & Dosage","Reduced-dose Apixaban","Thromboembolism",[318,319,320,321],"atrial fibrillation","left atrial appendage closure","anticoagulants","reduced dose apixaban","2026-05-04",{"date":324,"type":32},"2026-05-08",{"date":326,"type":21},"2026-04",{"date":328,"type":21},"2032-04",{"name":330,"class":331},"National Medical Research Center for Therapy and Preventive Medicine","OTHER_GOV",{"id":333,"slug":334,"hasResults":12,"nctId":335,"briefTitle":336,"officialTitle":337,"acronym":338,"eligibilityCriteria":339,"healthyVolunteers":12,"sex":151,"minAge":49,"maxAge":4,"enrollmentInfo":340,"targetDuration":4,"studyType":22,"phases":342,"briefSummary":343,"conditions":344,"keywords":349,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":352,"lastUpdatePostDateStruct":353,"startDateStruct":355,"completionDateStruct":357,"leadSponsor":358,"locationsCount":40},"100553123","phase-4-swift---swiss-factor-xiii-trial-in-pph-100553123","NCT06481995","SWIFT - SWIss Factor XIII Trial in PPH","Early Factor XIII Replacement in Postpartum Hemorrhage: Multi-center, Randomized, Controlled, Investigator-initiated Trial","SWIFT","Inclusion Criteria:\n\n* planned vaginal delivery\n* singleton vital pregnancy\n* gestational age at delivery \\>= 30+0 weeks\n* maternal weight at admission for delivery \\\u003C100 kg\n\nExclusion Criteria:\n\n* Antithrombotic therapy in pregnancy (therapeutic dosage) until admission for delivery (LMWH, UFH)\n* diagnosis of preeclampsia (ISSHP classification , eclampsia or HELLP syndrome),\n* known history of deep vein thrombosis or pulmonary embolism,\n* known diagnosis of bleeding disorder or thrombophilia,\n* known thrombocytopenia during second half of pregnancy with thrombocytes \\\u003C 100 G\u002FL,\n* known anemia during second half of pregnancy with Hb\\\u003C80 g\u002FL,\n* known sickle cell disease,\n* known malignant tumor(s),\n* participation in another study with investigational drug within the 30 days preceding and during the present study,\n* inability to follow the procedures of the study, e.g. due to language problems,\n* known or suspected non-compliance, drug or alcohol abuse.\n\nExclusion criteria prior randomization\n\n* Maternal fever ≥39.0°C\n* unplanned cesarean delivery is performed,\n* Measured Blood Loss remains \\\u003C 700 mL after administration of 1g tranexamic acid .\n* Postpartum hemorrhage due to occult bleeding (intra-abdominal, retroperitoneal, parametric),",{"count":341,"type":21},988,[155],"The goal of this trial is to determine if postpartum blood loss can be reduced by replenishing coagulation factor XIII (FXIII) at an early stage of postpartum hemorrhage (PPH).\n\nSummary of current body of evidence:\n\n* Morbidity and mortality due to PPH is rising.\n* Current guidelines focus on replenishment of fibrinogen as an initial step in the treatment of PPH-related coagulopathy, despite non-conclusive evidence in all prospective trials.\n* Trials from other specialties demonstrate a significant impact of FXIII on perioperative bleeding complications; a previous study at the University Hospital Zurich showed that pre-partum factor XIII activity had a strong association to postpartum blood loss.\n\nTherefore, this nationwide, multi-center, randomized, controlled trial in multiple perinatal centers across Switzerland will be conducted. The goal is to determine if postpartum blood loss and PPH-related complications can be reduced by replenishing FXIII.\n\nAll participating women receive, according to the national guideline, 1g tranexamic acid (TXA) i.v. in case of PPH (measured blood loss \\[MBL\\] ≥ 500 mL) during the pre-study phase. Randomization takes place if bleeding continues and exceeds 700mL. The intervention group then receives FXIII (Fibrogammin®) according to approved dosage in addition to obstetric standard of care treatment for causes of PPH; the control group receives only standard of care treatment.",[345,346,347,27,348],"Postpartum Hemorrhage","Coagulation Disorder","Coagulation Factor Deficiency","Postpartum Complication",[350,351],"Postpartum hemorrhage","coagulation factor XIII","2026-04-21",{"date":354,"type":32},"2026-04-27",{"date":356,"type":32},"2024-07-09",{"date":71,"type":21},{"name":359,"class":74},"Christian Haslinger",{"id":361,"slug":362,"hasResults":12,"nctId":363,"briefTitle":364,"officialTitle":365,"acronym":366,"eligibilityCriteria":367,"healthyVolunteers":12,"sex":151,"minAge":49,"maxAge":4,"enrollmentInfo":368,"targetDuration":4,"studyType":22,"phases":370,"briefSummary":371,"conditions":372,"keywords":378,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":386,"lastUpdatePostDateStruct":387,"startDateStruct":389,"completionDateStruct":391,"leadSponsor":392,"locationsCount":75},"100594452","u-cavit-versus-standard-of-care-for-prevention-of-atonic-postpartum-hemorrhage-after-cesarean-section-in-high-risk-women-100594452","NCT07019623","U-CaVIT Versus Standard of Care for Prevention of Atonic Postpartum Hemorrhage After Cesarean Section in High-risk Women.","Uro-catheter Vacuum-induced Uterine Tamponade (U-CaVIT) Versus Standard of Care for Prevention of Atonic Postpartum Hemorrhage After Cesarean Section in High-risk Women: a Monocentric Randomized-controlled Pilot Study.","UCaVIT Pilot","Inclusion Criteria:\n\n* Signed informed consent\n* Maternal age ≥18 years\n* Gestational age ≥30+0 weeks of pregnancy at day of delivery\n* Vital pregnancy\n* Delivery mode: planned cesarean delivery\n* High-risk patient for PPH specified by the presence of at least one of the following characteristics: Previous PPH, obesity (BMI ≥30 kg\u002Fm2), high parity (patient who has had ≥4 previous births (live or stillborn) at ≥20 weeks of gestation), very advanced maternal age ≥45 years, multiple gestation, polyhydramnios (defined as amniotic fluid index \\> 25 cm or deepest amniotic fluid pocket \\> 8 cm) at admission to delivery, suspected fetal macrosomia (estimated fetal weight ≥ 4500g)\n\nExclusion Criteria:\n\n* Insufficient language skills in German or English to understand and sign informed consent\n* Participation in another interventional study\n* Emergency cesarean section (incl. patients undergoing cesarean after failed vaginal delivery)\n* Subjects who change their delivery plan from vaginal to cesarean section in the course of hospitalization\n* Women with regular and painful contractions and women who do not have time for sufficient consideration\n* Clinical situations in which vacuum-induced uterine tamponade is unlikely to be effective or is contraindicated:\n\n  * Uterine or vaginal anomalies (genital tract congenital anomalies)\n  * Cesarean section due to placenta previa or suspected placenta accreta spectrum\n  * Suspected uterine rupture\n  * Injuries of the cervix or vagina\n  * Submucous or intramural uterine fibroids which are buldging into the uterine cavity\n  * Deep endometriosis \\[16, 17\\]\n* Planned atony-prophylaxis with oxytocin due to contraindication for carbetocin\n* Previous MMC-repair (myelomeningocele-repair)\n* Clinical diagnosis of chorioamnionitis, sepsis\n* Known allergy to silicone\n* Known and proven diagnosis of bleeding disorder or thrombophilia\n* Known thrombocytopenia during second half of pregnancy with thrombocytes \\\u003C 100 G\u002FL\n* Known anemia during second half of pregnancy with Hb\\\u003C80",{"count":369,"type":21},70,[87],"This pilot study aims to assess performance, safety and feasibility of U-CaVIT method (Uro-Catheter Vacuum Induced Tamponade), using the Rüsch® Brillant Silicone Balloon Catheter, an urological catheter, for the prevention of atonic PPH in high-risk women undergoing cesarean delivery.\n\nThe U-CaVIT method has been implemented at the Department of Obstetrics at university hospital of Zurich (USZ) due to temporary supply issues with the Bakri® Balloon Catheter. The Rüsch® Balloon Catheter is used in case of uterine atony when standard first-line uterotonic treatments have failed or in some cases as add-on therapy in non-atonic PPH. In the meantime, the use of U-CaVIT has become standard practice at the USZ for the treatment of atonic PPH, appearing to be user-friendly, clinically effective according to treating physicians, well tolerated by the treated women and cost-saving compared to the previously used Bakri® Balloon.",[373,27,348,374,375,376,377],"Postpartum Hemorrhage (Primary)","Delivery ,Complications,Maternal","Pregnancy Complications","Cesarean Delivery","Balloon",[345,379,380,381,382,383,384,385],"Delivery complications","high risk patients","Pregnancy","Balloon Catheter","Tamponade","prophylactic","Vacuum-induced tamponade","2026-04-17",{"date":388,"type":32},"2026-04-22",{"date":390,"type":32},"2025-05-28",{"date":213,"type":21},{"name":359,"class":74},{"id":394,"slug":395,"hasResults":12,"nctId":396,"briefTitle":397,"officialTitle":398,"acronym":4,"eligibilityCriteria":399,"healthyVolunteers":150,"sex":17,"minAge":400,"maxAge":401,"enrollmentInfo":402,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":403,"conditions":404,"keywords":408,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":410,"lastUpdatePostDateStruct":411,"startDateStruct":413,"completionDateStruct":415,"leadSponsor":417,"locationsCount":178},"100255235","nirs-monitoring-in-premature-infants-100255235","NCT02601339","NIRS Monitoring in Premature Infants","Beside Monitor of Cerebral Metabolism in Premature Infants With Intraventricular Hemorrhage and Post-Hemorrhagic Hydrocephalus","1. GM-IVH group:\n\n   Inclusion criteria for GM-IVH group: born at gestational age (GA) 24-32 weeks; \\\u003C 3 months old corrected-GA (cGA) at first measure or eligible for measurement within 12 weeks after the infant reaches 40 weeks post-menstrual age (PMA). Grade I-III IVH diagnosed by clinical cranial ultrasound or magnetic resonance imaging (MRI).\n\n   Exclusion criteria for GM-IVH group: chromosomal abnormalities known at the time of enrollment; known or suspected metabolic disorder or neoplasm; critical congenital heart disease; congenital hydrocephalus; brain lesions that affect cerebral brain metabolism, other than GMH-IVH; central nervous system (CNS) infection.\n2. PHH group:\n\n   Inclusion criteria for PHH group: born at gestational age (GA) 24-37 weeks \\\u003C 3 months old cGA at first measure or eligible for measurement within 12 weeks after the infant reaches 40 weeks age (PMA). PHH diagnosed by clinical cranial ultrasound or MRI.\n\n   Exclusion criteria for PHH group: chromosomal abnormalities known at the time of enrollment; known or suspected metabolic disorder or neoplasm; critical congenital heart disease; congenital hydrocephalus; brain lesions that affect cerebral brain metabolism, other than IVH-PHH; CNS infection. Implanted devices or other devices that preclude the use of MRI.\n3. HC group:\n\n   Inclusion criteria for HC group: born at gestational age (GA) 24-32 weeks; \\\u003C 3 months old cGA at first measure or eligible for measurement within 12 weeks after the infant reaches 40 weeks age (PMA); Apgar \\>7 at 5 min.\n\n   Exclusion criteria for HC group: any clinical indication of brain injury or congenital brain malformation; chromosomal abnormality known at the time of enrollment; known or suspected metabolic disorder or neoplasm; critical congenital heart disease; CNS infection.\n4. VC group:\n\nInclusion criteria for VC group: \\\u003C 12 months old cGA at first measure or eligible for measurement within 1 year after the infant reaches 40 weeks age (PMA). Symptomatic hydrocephalus of any etiology or at high risk of developing hydrocephalus of any etiology, except post-hemorrhagic etiology; characterized by abnormal rate of head growth and full anterior fontanelle. Ventricular enlargement diagnosed by ultrasonography or MRI; no signs of IVH.\n\nExclusion criteria for VC group: known or suspected metabolic disorder or neoplasm; critical congenital heart disease; CNS infection. Implanted devices or other devices that preclude the use of MRI.","0 Months","12 Months",{"count":369,"type":21},"This study uses frequency domain near-infrared spectroscopy coupled with diffuse correlation spectroscopy (FDNIRS-DCS) technology for monitoring cerebral blood flow (CBF) and cerebral oxygen metabolism (CMRO2) at the bedside for newborns with germinal matrix-intraventricular hemorrhage (GM-IVH) and\u002For post-hemorrhagic hydrocephalus (PHH) in comparison to newborns with hydrocephalus of a different etiology (VC) and healthy controls (HC). We hypothesize that baseline cerebral metabolic dysfunction is a better biomarker for GM-IVH and PHH severity and response to PHH treatment.\n\nThis is a Boston Children's Hospital (BCH)-institutional review board(IRB) approved, multi-site study that includes collaboration with Brigham and Women's Hospital (BWH) and Beth Israel Deaconess Medical Center (BIDMC). Pei-Yi Lin receives funding from The National Institute of Health (NIH) to support the study and is the overall principal Investigator (PI) overseeing the study.",[27,405,406,407],"Premature Infants","Newborn","Hydrocephalus",[409],"spectroscopy, Near-Infrared","2026-03-16",{"date":412,"type":32},"2026-03-18",{"date":414,"type":32},"2015-04",{"date":416,"type":21},"2026-12",{"name":418,"class":74},"Boston Children's Hospital",{"id":420,"slug":421,"hasResults":12,"nctId":422,"briefTitle":423,"officialTitle":423,"acronym":424,"eligibilityCriteria":425,"healthyVolunteers":12,"sex":17,"minAge":49,"maxAge":426,"enrollmentInfo":427,"targetDuration":4,"studyType":22,"phases":429,"briefSummary":430,"conditions":431,"keywords":433,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":439,"lastUpdatePostDateStruct":440,"startDateStruct":442,"completionDateStruct":444,"leadSponsor":446,"locationsCount":75},"100616879","phase-4-oral-hygiene-and-prophylactic-antibiotics-to-prevent-intracerebral-hemorrhage-associated-pneumonia-100616879","NCT07311343","Oral Hygiene and Prophylactic Antibiotics to Prevent Intracerebral Hemorrhage Associated Pneumonia","OCEAN","Inclusion Criteria:\n\n1. Age 18-80 years old;\n2. Spontaneous intracerebral hemorrhage;\n3. Supratentorial intracerebral hemorrhage (ICH);\n4. Hematoma volume \\\u003C 30 ml (calculated by ABC\u002F2 method);\n5. Glasgow Coma Scale score ≥ 9 at randomization;\n6. Time from onset to randomization ≤ 72 hours;\n7. Spontaneous intracerebral hemorrhage-associated pneumonia score (ICH-APS) ≥ 8;\n8. Informed consent from the patient and\u002For their family.\n\nExclusion Criteria:\n\n1. Secondary intracerebral hemorrhage, such as that resulting from cerebral aneurysms, cerebral arteriovenous malformations, brain tumors, cerebral venous system thrombosis, antithrombotic therapy (antiplatelet, anticoagulant therapy, etc.), hemorrhagic transformation after cerebral infarction, hematological diseases, etc.\n2. The patient's clinical symptoms and signs suggest signs of brain herniation, such as progressive decline in consciousness level, weakened or absent pupillary light reflex.\n3. Obvious signs of pneumonia already exist, such as fever, persistent cough or yellow purulent sputum, and imaging examinations (chest X-ray or chest CT) suggest signs of pneumonia; two consecutive measurements of body temperature ≥ 37.5℃, or one measurement of body temperature ≥ 38.0℃.\n4. A history of severe cardiovascular disease, meeting any of the following: 1) Heart failure (New York Heart Association functional class ≥ III); 2) Unstable angina within 3 months; 3) Any supraventricular or ventricular arrhythmia requiring treatment; 4) Prolonged QTc interval considered clinically significant by the investigator (reference range: \\> 450ms for men, \\> 470ms for women) (Note: QTc interval must be calculated according to Fridericia's formula); 5) Complete atrioventricular block and left or right bundle branch block requiring treatment; 6) Acute myocardial infarction or interventional treatment within 1 month; high-risk patients with chronic arrhythmia, such as sick sinus syndrome, second or third-degree atrioventricular block, bradycardia-related syncope without pacemaker installation, etc.\n5. Diagnosed with severe active liver disease, such as acute hepatitis, chronic active hepatitis, liver cirrhosis, etc.; or ALT or AST \\> 3 times the upper limit of normal.\n6. Severe renal insufficiency: such as patients undergoing dialysis, or diagnosed with severe active kidney disease, etc., or creatinine clearance rate \\\u003C 50 mL\u002Fmin.\n7. Other severe diseases that lead to an expected lifespan of less than 1 year.\n8. Patients scheduled for surgical intervention before the first administration, including but not limited to hematoma evacuation (including minimally invasive and conventional surgery), decompressive craniectomy, hematoma aspiration, and external ventricular drainage.\n9. Patients unable to understand the research procedures and\u002For complete follow-up due to mental illness, cognitive impairment, emotional disorders, etc.\n10. Pregnant or lactating women.\n11. Participation in other clinical studies within 3 months or currently participating in other clinical studies.\n12. Known allergy to cephalosporins, penicillins, or chlorhexidine compound mouthwash.\n\n    \\-","80 Years",{"count":428,"type":21},440,[155],"Project Name:\n\nRandomized Controlled Clinical Study on oral hygiene and prophylactic antibiotics to prevent Intracerebral Hemorrhage associated pneumonia\n\nResearch Objectives:\n\nTo evaluate the effectiveness, safety and health economics value of enhanced oral hygiene combined with antibiotics in preventing post-cerebral hemorrhage pneumonia.\n\n1. To clarify the effectiveness of enhanced oral hygiene combined with antibiotics in preventing post-cerebral hemorrhage pneumonia.\n2. To clarify the safety of enhanced oral hygiene combined with antibiotics in preventing post-cerebral hemorrhage pneumonia.\n3. To clarify the health economics value of low-intensity enhanced oral hygiene combined with antibiotics in preventing post-cerebral hemorrhage pneumonia.\n\nResearch Design:\n\nResearch Type: Multicenter, Randomized, Controlled, Open Label, Blinded Endpoint Research Design Research Hypothesis: Intensive oral hygiene combined with antibiotic treatment is beneficial in reducing the incidence of pulmonary infections related to cerebral hemorrhage.",[27,432],"Pneumonia",[434,435,436,437,438],"Cerebral hemorrhage","Stroke Associated Pneumonia","oral care","prophylactic antibiotics","effectiveness","2026-02-11",{"date":441,"type":32},"2026-02-12",{"date":443,"type":32},"2026-01-07",{"date":445,"type":21},"2027-10-31",{"name":447,"class":74},"Beijing Tiantan Hospital",{"id":449,"slug":450,"hasResults":12,"nctId":451,"briefTitle":452,"officialTitle":453,"acronym":454,"eligibilityCriteria":455,"healthyVolunteers":12,"sex":17,"minAge":456,"maxAge":457,"enrollmentInfo":458,"targetDuration":4,"studyType":22,"phases":460,"briefSummary":461,"conditions":462,"keywords":466,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":471,"lastUpdatePostDateStruct":472,"startDateStruct":474,"completionDateStruct":476,"leadSponsor":478,"locationsCount":4},"100392231","phase-3-traumatic-injury-clinical-trial-evaluating-tranexamic-acid-in-children-an-efficacy-study-100392231","NCT04387305","Traumatic Injury Clinical Trial Evaluating Tranexamic Acid in Children: An Efficacy Study","Traumatic Injury Clinical Trial Evaluating Tranexamic Acid in Children (TIC-TOC): An Efficacy Study","TIC-TOC","Inclusion Criteria:\n\n1. Less than 18 years old AND\n2. Penetrating torso trauma, blunt torso trauma, or head trauma as defined below:\n3. Penetrating Torso Trauma:\n\n   a. Penetrating trauma to the chest, abdomen, neck, or pelvis with at least one of the following:\n   * age-adjusted hypotension, or\n   * age-adjusted tachycardia despite adequate resuscitation fluids, or\n   * radiographic evidence of internal hemorrhage, or\n   * clinician suspicion of ongoing internal hemorrhage\n4. Blunt Torso Trauma:\n\n   1. Clinician suspicion of hemorrhagic blunt torso injury and at least one of the following:\n\n      * age-adjusted hypotension, or\n      * age-adjusted tachycardia despite adequate resuscitation fluids\n   2. Hemothorax on chest tube placement or imaging,\n   3. Clinical suspicion of hemorrhagic blunt torso injury and Intraperitoneal fluid on abdominal ultrasonography (Focused Assessment with Sonography in Trauma),\n   4. Intra-abdominal injury on CT with either contrast extravasation or more than trace intraperitoneal fluid,\n   5. Pelvic fracture with contrast extravasation or hematoma on abdominal\u002Fpelvic CT scan with at least one of the following:\n\n      * Age-adjusted hypotension, or\n      * Age-adjusted tachycardia.\n5. Head Trauma:\n\n   1. Initial Glasgow Coma Scale (GCS) score 3 to 13 with associated intracranial hemorrhage on cranial CT scan (enroll after cranial CT scan)\n\nExclusion Criteria:\n\n* Unable to administer study drug within 3 hours of traumatic event\n* Known pregnancy\n* Known ward of the state\n* Cardiac arrest prior to randomization\n* GCS score of 3 with bilateral unresponsive pupils\n* Isolated subarachnoid hemorrhage, epidural hematoma, or diffuse axonal injury\n* Known venous or arterial thrombosis\n* Known bleeding\u002Fclotting disorders\n* Known seizure disorders\n* Known history of severe renal impairment\n* Known allergy to TXA\n* Unknown time of injury (includes suspected non-accidental trauma)\n* Previous enrollment into the TIC-TOC trial\n* Prior TXA for current injury\n* Prior opt-out\n* Non-English and non-Spanish speaking","0 Years","17 Years",{"count":459,"type":21},2000,[24],"Trauma is the leading cause of death and disability in children in the United States. The objective of this study is to evaluate the benefits and harms of tranexamic acid (TXA; a drug that stops bleeding) in severely injured children with hemorrhagic brain and\u002For torso injuries. Using thromboelastography, we will measure baseline fibrinolysis to assess for treatment effects of TXA at different levels of fibrinolysis.",[463,464,27,465],"Brain Injuries, Traumatic","Wounds and Injury","Trauma Injury",[167,467,27,468,469,470,128],"Brain Injuries","Clinical Trial","Children","Pediatric","2025-12-09",{"date":473,"type":32},"2025-12-15",{"date":475,"type":21},"2026-10-01",{"date":477,"type":21},"2031-03-31",{"name":479,"class":74},"Daniel Nishijima, MD, MAS",{"id":481,"slug":482,"hasResults":12,"nctId":483,"briefTitle":484,"officialTitle":484,"acronym":485,"eligibilityCriteria":486,"healthyVolunteers":150,"sex":17,"minAge":49,"maxAge":487,"enrollmentInfo":488,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":490,"conditions":491,"keywords":493,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":502,"lastUpdatePostDateStruct":503,"startDateStruct":505,"completionDateStruct":507,"leadSponsor":509,"locationsCount":75},"100497375","consortium-for-optimized-integration-of-bio-artificial-blood-components-for-adaptive-resuscitation-therapy-100497375","NCT05756426","Consortium for Optimized Integration of Bio-Artificial Blood Components for Adaptive Resuscitation Therapy","CONCERT","Inclusion Criteria:\n\n* Subject \\>\u002F= 18 years of age\n* Subject weighs \\>40kg (88lbs)\n* Subject must be generally healthy\n\nExclusion Criteria:\n\n* Suspected or diagnosed with ongoing (chronic) or acute infection\n* Subject is pregnant\n* Subject is non-english speaking","88 Years",{"count":489,"type":21},250,"There is need for a whole blood analog for use when banked blood is unavailable or undesirable.\n\nIn civilian trauma, hemorrhage accounts for \\~ 35% of pre-hospital deaths; moreover, \\~ 20% of military casualties are in hemorrhagic shock on arrival to field hospitals and an additional 5% require urgent transfusion. A recent review concluded that hemorrhage accounted for \\~ 90% of potentially survivable battlefield deaths - lives that could be saved with better hemorrhage control capabilities and improved, field-ready blood, blood components, or blood substitutes. While study of ideal composition for resuscitative fluids is ongoing, it is evident that for those in hemorrhagic shock, volume replenishment alone (without O2 carrying capacity) is insufficient. Alternatively, with massive blood loss or with ongoing bleeding from non-compressible injuries, resuscitation with an O2 carrier alone may be complicated by acquired coagulopathy (either dilutional or trauma-induced).\n\nDevelopment of a balanced resuscitation fluid that treats both shock and coagulopathy (comprising a field-deployable O2 carrier with lyophilized humoral hemostatic components and platelets) is essential to allow on-scene treatment during the critical 'golden-hours' after injury. As such, the whole blood analog described herein could be this product, thus transforming care in both civilian and military settings.The scientific purpose of this study is to develop a combined whole blood substitute from individual artificial prototypes that have been separately developed for each blood component (i.e., combining an artificial oxygen carrier, with an artificial plasma analogue and an artificial platelet analogue). Together, these combined components will recapitulate the composition and performance of natural whole blood.\n\nBlending and combination experiments of the individual artificial prototypes will be performed to test compatibility and optimize efficacy. State of the art in vitro (bench top) assays will be performed to assess physicochemical and functional performance (hemodynamics, oxygen delivery, hemostasis), with data being compared to experiments performed on fresh and stored whole blood.",[27,492],"Hemodynamic Instability",[494,495,496,497,498,499,500,501],"Hemostasis","Vasoactivity","Oxygen affinity","Red Blood Cell","Whole blood analogue","Perfusion","Nitric Oxide","Methemoglobin","2025-10-01",{"date":504,"type":32},"2025-10-07",{"date":506,"type":32},"2023-04-13",{"date":508,"type":21},"2029-01-30",{"name":510,"class":74},"University of Maryland, Baltimore",{"id":512,"slug":513,"hasResults":12,"nctId":514,"briefTitle":515,"officialTitle":516,"acronym":517,"eligibilityCriteria":518,"healthyVolunteers":12,"sex":17,"minAge":519,"maxAge":520,"enrollmentInfo":521,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":522,"conditions":523,"keywords":526,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":529,"lastUpdatePostDateStruct":530,"startDateStruct":532,"completionDateStruct":534,"leadSponsor":535,"locationsCount":75},"100536303","hemodynamic-monitoring-during-craniosynostosis-surgery-comparing-traditional-and-newer-technology-monitors-crasy-pram-100536303","NCT06263075","Hemodynamic Monitoring During Craniosynostosis Surgery: Comparing Traditional and Newer Technology Monitors (CRASY-PRAM)","Evaluation of the Hemodynamic Variability During Craniosynostosis Surgery: a Comparison Between Traditional Hemodynamic Monitoring and Pressure Recording Analytic Method (CRASY-PRAM)","CRASY-PRAM","Inclusion Criteria:\n\n* Infants with craniosynostosis undergoing corrective surgery\n* Ages between 3 and 8 months\n* Physical status classification of the American Society of Anesthesiologists (ASA) \\\u003C\u002F= 2\n* Consent obtained from the patients' parents\u002Flegal guardians\n\nExclusion Criteria:\n\n* Congenital or acquired cardiac disease\n* Preoperative cardiac dysfunction\n* Metabolic diseases\n* Gestational age at birth \\\u003C30 weeks\n* Body weight less than 3 kg\n* Dislocation or malfunction of the arterial catheter\n* Malfunctioning of monitoring devices","3 Months","8 Months",{"count":187,"type":21},"Hemodynamic evaluation during pediatric anesthesia is essential to care management. Intraoperative cardiovascular instability is frequent in major surgeries, and appropriate monitoring is necessary to ensure safe anesthetic conduction and promptly detect changes in blood pressure, cardiac output, blood volume, and organ perfusion. In this context, advanced hemodynamic monitoring, continuous measuring, and estimating various parameters can allow a more specific hemodynamic profile and help identify the causal mechanisms of its variability. Moreover, the reference ranges of hemodynamic values in different pediatric ages and how to best monitor hemodynamic status in pediatrics are still debated.\n\nSurgical treatment of craniosynostosis is usually performed at an early age, between 3 and 8 months of age. The operation is burdened by a high risk of hemodynamic instability related mainly, but not only, to potential substantial hemorrhagic losses.\n\nThis study aims to characterize the hemodynamic events occurring during corrective craniosynostosis surgery, recorded simultaneously with standard monitoring and Pressure Recording Analytic Method (PRAM), and to analyze the paired measurements.",[524,525,27,492],"Craniosynostoses","Hypovolemia",[527,528],"Monitoring Physiologic","Monitoring Intraoperative","2025-09-30",{"date":531,"type":32},"2025-10-03",{"date":533,"type":32},"2023-12-13",{"date":106,"type":21},{"name":536,"class":74},"IRCCS Azienda Ospedaliero-Universitaria di Bologna",{"id":538,"slug":539,"hasResults":12,"nctId":540,"briefTitle":541,"officialTitle":541,"acronym":4,"eligibilityCriteria":542,"healthyVolunteers":12,"sex":17,"minAge":543,"maxAge":281,"enrollmentInfo":544,"targetDuration":4,"studyType":22,"phases":546,"briefSummary":547,"conditions":548,"keywords":550,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":556,"lastUpdatePostDateStruct":557,"startDateStruct":559,"completionDateStruct":561,"leadSponsor":563,"locationsCount":75},"100602862","phase-3-optimization-strategies-for-blood-transfusion-protocols-in-the-emergency-treatment-of-hemorrhagic-shock-100602862","NCT07129031","Optimization Strategies for Blood Transfusion Protocols in the Emergency Treatment of Hemorrhagic Shock","Inclusion Criteria:\n\n* Patients with hemorrhagic shock due to trauma or upper gastrointestinal bleeding who meet emergency transfusion criteria (hemoglobin \\\u003C 7 g\u002FdL or active bleeding).\n\nAge 10-90 years. Time from onset to hospital admission \\\u003C 24 hours.\n\nExclusion Criteria:\n\n* Severe underlying diseases (end-stage organ failure or active malignancy). Known coagulopathy or history of severe transfusion reactions. Refusal to participate or inability to complete follow-up.","10 Years",{"count":545,"type":21},180,[24],"This single-center, prospective, randomized controlled trial was approved by the institutional ethics committee and overseen by an independent data and safety monitoring board. It enrolled patients with hemorrhagic shock caused by trauma or major gastrointestinal bleeding. Using a random-number-table method, participants were allocated to three groups: (1) Control group: standard massive transfusion protocol (MTP) with transfusing type-specific blood components in a 1:1:1 ratio. (2) Type-specific whole-blood group: following emergency ABO typing and cross-matching, type-specific whole blood was transfused. (3) Low-titer group O whole-blood group: in the emergency phase, 4 units of low-titer group O whole blood (anti-A\u002FB IgM titer \\\u003C 1:64) were infused; after definitive ABO typing, patients were switched to type-specific whole blood. Clinical data were automatically extracted from the electronic medical record system. Primary endpoints were efficacy (28-day survival), timeliness (transfusion waiting time and time to achieve target mean arterial pressure), cost-effectiveness (total blood consumption and transfusion-related expenses), and safety (transfusion-associated adverse events including TRALI and hemolytic reactions).Statistical analyses included Kaplan-Meier survival curves and Cox proportional-hazards regression, adjusting for confounders such as age and disease severity scores. The advantages and disadvantages of each transfusion strategy were evaluated, and an optimized strategy for emergency blood transfusion in hemorrhagic shock was developed. This strategy was peer-reviewed and refined, culminating in a standardized, multidisciplinary, emergency-transfusion protocol.",[27,125,549],"Upper Gastrointestinal Bleeding (UGIB)",[551,552,553,554,555],"Hemorrhagic shock","transfusion","low-titer O-group whole blood","group of 1:1:1 component","group of ABO- and Rh-compatible whole blood","2025-08-18",{"date":558,"type":32},"2025-08-19",{"date":560,"type":21},"2025-09-01",{"date":562,"type":21},"2027-12-31",{"name":564,"class":74},"Xijing Hospital",{"id":566,"slug":567,"hasResults":12,"nctId":568,"briefTitle":569,"officialTitle":569,"acronym":4,"eligibilityCriteria":570,"healthyVolunteers":12,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":571,"targetDuration":4,"studyType":22,"phases":573,"briefSummary":575,"conditions":576,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":556,"lastUpdatePostDateStruct":579,"startDateStruct":580,"completionDateStruct":582,"leadSponsor":584,"locationsCount":75},"100542666","early-phase-1-topical-and-local-txa-in-facelifts---a-randomized-controlled-double-blinded-study-100542666","NCT06345833","Topical and Local TXA in Facelifts - A Randomized Controlled Double Blinded Study","Inclusion Criteria:\n\n* Eligible participants will consist of all regular clinic patients who elect and are deemed fit by the surgeon to undergo facelift surgery, including patients undergoing ancillary procedures\n* age 18 and older\n* English speaking.\n\nExclusion Criteria:\n\n* younger than 18\n* previously had an adverse reaction to tranexamic acid\n* non-English speaking\n* patients who elect not to participate or withdraw from the study.",{"count":572,"type":21},50,[574],"EARLY_PHASE1","Tranexamic acid (TXA) is a fibrinolytic inhibitor which prevents prolonged bleeding by interfering with fibrin clot breakdown by competitively binding to lysine receptors on plasminogen; this prevents the conversion of plasminogen to plasmin. TXA will be applied to a randomly assigned side of the face during facelift surgery. The intervention groups will include 1% TXA mixed with standard local consisting 1\u002F4% lidocaine with 1:100,000 epinephrine, 3% TXA on TXA-soaked pledgets applied for 10 minutes, and 1% TXA with local plus 3% TXA-soaked pledgets. Each treatment arm will be compared to saline in place of TXA on the contralateral side of the face.\n\nAlthough TXA has been widely used in surgical fields for decades and is officially recommended by agencies such as ACOG for use during maternal hemorrhage, its current FDA approval only pertains to oral TXA for heavy menstrual bleeding and IV use for patients with hemophilia to prevent or reduce hemorrhage (cite). The main concern with intravenous TXA is the increased risk for the potential formation of blood clots, mainly in patients with clotting disorders, such as Facor V Leiden, and patients on estrogen containing medication. A recent systemic review with metanalysis by Wang et.al contained a total of 2150 patients receiving IV TXA while undergoing plastic surgery concluded that use of IV TXA does not lead to increased adverse events.\\[12\\] Given the low rate of adverse events while using TXA systemically, this protocol's application of TXA topically and\u002For locally negates the risk for any potential systemic adverse effects. No systemic adverse effects have been reported in studies examining local TXA in facial plastic surgery to date.",[577,27,578],"Hemophilia","Facelift Surgery",{"date":558,"type":32},{"date":581,"type":32},"2024-07-01",{"date":583,"type":21},"2026-07-01",{"name":585,"class":74},"University of Minnesota",{"id":587,"slug":588,"hasResults":12,"nctId":589,"briefTitle":590,"officialTitle":591,"acronym":592,"eligibilityCriteria":593,"healthyVolunteers":12,"sex":17,"minAge":49,"maxAge":426,"enrollmentInfo":594,"targetDuration":4,"studyType":22,"phases":595,"briefSummary":596,"conditions":597,"keywords":601,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":604,"lastUpdatePostDateStruct":605,"startDateStruct":607,"completionDateStruct":609,"leadSponsor":610,"locationsCount":75},"100591364","q-therapeutic-system-for-chronic-stroke-recovery-100591364","NCT06979466","Q Therapeutic System for Chronic Stroke Recovery","Facilitation Recovery For Patients With Chronic Stroke: The Q Therapeutic System, Frequency-Tuned Electromagnetic Field Treatment","EMAGINE-C","Inclusion Criteria:\n\n* FMA-UE score between 22-50 (inclusive) of impaired limb.\n* Difference between Screening and Baseline visit FMA-UE is 3 points or fewer.\n* Age 18 to 80 years of age (inclusive).\n* Stroke due to ischemia or to intracerebral hemorrhage.\n* \\>6 months to 5 years from index stroke onset.\n* Box \\& Block Test score with affected arm is ≥1 block in 60 seconds at Baseline Visit.\n* Able to sit with the investigational System for 40 consecutive minutes.\n* Can follow a 3-step command, such as \"take the paper, fold it in half, and return it to me\", or a non-verbal equivalent.\n* Willingness to participate in physical exercises during study intervention sessions.\n* Availability of a relative or other caregiver able to assist during study treatment sessions and visits.\n* If female, not pregnant or breastfeeding or planning pregnancy during the study period.\n* Informed consent signed by subject.\n\nExclusion Criteria:\n\n* Severe neglect impairment interfering with assessments or treatments.\n* Severe depression, defined as GDS Score \\>10\u002F15\n* The presence of MR-incompatible implanted devices or MR-incompatible retained objects; or the presence of life-sustaining MR-compatible devices (e.g. pacemaker or internal cardiac defibrillator).\n* Active epilepsy or currently taking anti-epileptic medication (indicated for the treatment of a seizure disorder), or any epileptic seizure in the last 5 years\n* Botulinum toxin to the paretic arm: received in the prior 3 months OR expected before the 6-Month Visit\n* Severe UE spasticity, defined as presence of upper extremity contracture or modified Ashworth Scale score≥3 in either biceps or pectoralis\n* Pre-existing neurological condition (eg, Alzheimer's disease, Parkinson's disease, multiple sclerosis, traumatic brain injury, spinal cord injury) or physical limitation that would interfere significantly with the subject's participation in the study and\u002For confound neurological or functional evaluation.\n* Significant visual disturbances, pre-existing or resulting from the index stroke, that cannot be corrected and that would interfere significantly with the subject's participation in the study and\u002For confound neurological or functional evaluation.\n* Unstable serious illness\u002Fcondition (eg, active cancer, severe heart failure, active major psychiatric condition) or life expectancy of less than 12 months.\n* Alcohol abuse and\u002For illicit drug abuse in the past 6 months, which is likely to influence ability to fully participate in the trial.\n* Participation in another interventional trial that would conflict with the current study or clinical endpoint interference may occur.\n* Participation in an upper extremity rehabilitation program provided by a licensed provider in the 4 weeks prior to the Screening visit, or a or planned participation in such program at any time between the Screening Visit and the primary endpoint visit.\n* Employee of the Sponsor.\n* Prisoner.",{"count":7,"type":21},[87],"Evaluate the effectiveness of the Q Therapeutic (BQ 3.0) System for individuals with chronic stroke in improving upper extremity function as determined by change in functional outcome measures after 3-month treatment, including in-clinic and at-home sessions.",[97,27,598,599,600],"Brain Injury","Cerebrovascular Accident (CVA)","Chronic Stroke Patient",[602,97,91,603],"BrainQ","Electromagnetic Stimulation","2025-08-07",{"date":606,"type":32},"2025-08-12",{"date":608,"type":32},"2025-05-26",{"date":31,"type":21},{"name":611,"class":74},"Burke Rehabilitation Hospital",{"id":613,"slug":614,"hasResults":12,"nctId":615,"briefTitle":616,"officialTitle":616,"acronym":4,"eligibilityCriteria":617,"healthyVolunteers":12,"sex":17,"minAge":49,"maxAge":618,"enrollmentInfo":619,"targetDuration":4,"studyType":22,"phases":621,"briefSummary":622,"conditions":623,"keywords":626,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":632,"lastUpdatePostDateStruct":633,"startDateStruct":635,"completionDateStruct":637,"leadSponsor":639,"locationsCount":75},"100600537","phase-4-role-of-tranexamic-acid-in-reducing-hemorrhagic-events-in-bariatric-surgery-100600537","NCT07098780","Role of Tranexamic Acid in Reducing Hemorrhagic Events in Bariatric Surgery","Inclusion Criteria:\n\n* Patients above 18 years of age AND\n* Undergoing Laparoscopic Sleeve Gastrectomy and MGB\n* Morbid obesity\n\nExclusion Criteria:\n\n* Patients on anti-platelets\u002Fanti-coagulants\n* Patients with inherited or acquired bleeding disorders\n* Patients with any acute medical condition predisposing to bleeding\n* Hormonal contraceptives\n* Known Allery to TXA\n* Female hormonal replacement therapy","60 Years",{"count":620,"type":21},140,[155],"The goal of this clinical trial is to learn if tranexamic acid (TXA) helps reduce bleeding during bariatric surgery, such as laparoscopic sleeve gastrectomy (LSG) and mini gastric bypass (MGB). It will also look at how safe TXA is for people undergoing these procedures. The main questions it aims to answer are:\n\nDoes TXA reduce the amount of blood loss during bariatric surgery? Are there any side effects or complications in patients who receive TXA? Researchers will compare TXA to standard care (no TXA) to see if it is effective in reducing bleeding.\n\nParticipants will:\n\nReceive either TXA or no TXA (placebo) before surgery Undergo standard bariatric surgery (LSG or MGB) Have their blood loss, hemoglobin levels, and any complications monitored during and after surgery",[27,624,625],"Bariatric Surgery","Obesity, Morbid",[627,628,629,630,631],"Bariatric surgery","Tranexamic Acid","Hemorrhage in bariatric surgery","RCT","Randomised controlled trial","2025-07-29",{"date":634,"type":32},"2025-08-01",{"date":636,"type":32},"2023-06-12",{"date":638,"type":21},"2025-08-31",{"name":640,"class":74},"Patel Hospital, Pakistan",{"id":642,"slug":643,"hasResults":12,"nctId":644,"briefTitle":645,"officialTitle":646,"acronym":4,"eligibilityCriteria":647,"healthyVolunteers":150,"sex":151,"minAge":49,"maxAge":648,"enrollmentInfo":649,"targetDuration":4,"studyType":22,"phases":651,"briefSummary":652,"conditions":653,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":654,"lastUpdatePostDateStruct":655,"startDateStruct":657,"completionDateStruct":659,"leadSponsor":661,"locationsCount":75},"100526953","phase-2-changes-in-hemorrhage-with-prophylactic-oxytocin-for-dilation-and-evacuation-100526953","NCT06141447","Changes in Hemorrhage With Prophylactic Oxytocin for Dilation and Evacuation","Changes in Rate of Hemorrhage With Prophylactic Oxytocin for Second Trimester Dilation and Evacuation in the Clinic Setting","Inclusion Criteria:\n\n* clinic-based D\\&E at 18 weeks gestational age and above\n* speaks English or Spanish\n\nExclusion Criteria:\n\n* refuses IV\n* history of coagulopathy\n* anticoagulant use in the preceding five days\n* chorioamnionitis or sepsis\n* suspected placenta accreta spectrum\n* intrauterine fetal demise\n* multiple gestation\n* use of misoprostol for cervical preparation","55 Years",{"count":650,"type":21},150,[285],"The purpose of this study is to assess the effectiveness of prophylactic oxytocin on hemorrhage rates for second trimester dilation and evacuation (D\\&E) in the clinic setting.",[27],"2024-12-05",{"date":656,"type":32},"2024-12-10",{"date":658,"type":32},"2024-05-02",{"date":660,"type":21},"2026-11-02",{"name":662,"class":74},"University of Colorado, Denver",{"id":664,"slug":665,"hasResults":12,"nctId":666,"briefTitle":667,"officialTitle":668,"acronym":669,"eligibilityCriteria":670,"healthyVolunteers":12,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":671,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":673,"conditions":674,"keywords":677,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":687,"lastUpdatePostDateStruct":688,"startDateStruct":690,"completionDateStruct":692,"leadSponsor":694,"locationsCount":75},"100569304","adverse-drug-events-in-patients-on-oral-anticoagulation-in-the-emergency-department-100569304","NCT06692504","Adverse Drug Events in Patients on Oral Anticoagulation in the Emergency Department","Real-life Epidemiology of Adverse Drug Events in Patients on Oral Anticoagulation in the Emergency Department Setting","ADEOA","Inclusion Criteria:\n\n* Age ≥18 years\n* Admission to adult emergency department of Besançon University Hospital\n* Study period: January 1, 2018 to December 31, 2019\n* Current oral anticoagulation therapy with:\n\n  * Acenocoumarol\n  * Apixaban\n  * Dabigatran\n  * Fluindione\n  * Rivaroxaban\n  * Warfarin\n\nExclusion Criterion:\n\n\\- Discontinuation of anticoagulant therapy for more than 24 hours",{"count":672,"type":21},2080,"Rationale:\n\nAccording to the latest National Survey on Care-Related Adverse Events, anticoagulants, including vitamin K antagonists (VKAs), rank first among medications responsible for serious iatrogenic accidents (37% in 2004, 31% in 2009). The EMIR study (2007) showed that VKAs were the leading cause of hospitalization for adverse effects (12.3%), with approximately 5,000 fatal hemorrhage-related accidents annually. Treatment and prevention of thromboembolic events represent a major public health challenge due to increased mortality, severity of functional sequelae, growing number of patients requiring treatment, and medical, social, and economic consequences. In 2013, an estimated 3.12 million patients received anticoagulation (4-5% of the French population). Several types of adverse events under oral anticoagulation appear to have high incidence in emergency settings: traumatic hemorrhage, spontaneous hemorrhage, asymptomatic overdose, and thrombosis. Different variables are associated with these events in patients admitted to emergency departments under oral anticoagulant treatment, but few studies have been conducted in real-world settings with large patient samples.\n\nHypothesis:\n\nIatrogenic events have a high incidence in patients admitted to emergency departments under oral anticoagulants and are a factor in early and late morbidity and mortality.\n\nPrimary Objective:\n\nTo describe the characteristics of patients admitted to the emergency department on oral anticoagulant therapy, with a particular focus on characterizing those presenting with Adverse Drug Events (ADEOA).\n\nStudy Design:\n\n* Type: Observational, descriptive study\n* Duration: 36 months total (24 months for data collection, 12 months for analysis)\n* Sample Size: Estimated 2,080 patients (approximately 20 patients\u002Fweek over 2 years)\n\nInclusion Criteria:\n\n* Age ≥18 years\n* Admission to adult emergency department\n* Study period: January 1, 2018 to December 31, 2019\n* Current oral anticoagulation therapy with:\n\n  * Acenocoumarol (Sintrom®\u002FMinisintrom®)\n  * Apixaban (Eliquis®)\n  * Dabigatran (Pradaxa®)\n  * Fluindione (Previscan®)\n  * Rivaroxaban (Xarelto®)\n  * Warfarin (Coumadine®)\n\nExclusion Criterion:\n\n\\- Discontinuation of anticoagulant therapy for more than 24 hours\n\nPrimary Outcome Measures:\n\n1. Description of oral anticoagulant groups based on medication type\n2. Characterization of Adverse Drug Events in Patients on Oral Anticoagulation in the Emergency Department (ADEOA):\n\n   1. Presence of ADEOA:\n\n      * Traumatic hemorrhage: acute bleeding following recent trauma\n      * Spontaneous hemorrhage: acute bleeding unrelated to recent trauma\n      * Asymptomatic overdose: INR \\>3 for vitamin K antagonist patients\n      * Thrombosis: new arterial or venous thrombosis despite ongoing anticoagulation\n   2. Absence of ADEOA\n\nSecondary Outcome Measures:\n\n1. Assessment of adherence to oral anticoagulant prescribing guidelines\n2. Identification of etiological factors for anticoagulation-related adverse events\n3. Identification of early morbidity and mortality risk factors\n4. Evaluation of medical-economic impact of adverse events and cost-effectiveness analysis of adverse events\n5. Quality of life assessment",[27,57,675,676],"Anticoagulant Therapy","Traumatic Hemorrhage",[678,679,680,681,166,682,683,684,57,685,686],"anticoagulant therapy","oral anticoagulant","emergency department","emergency medicine","Traumatic hemorrhage","Spontaneous hemorrhage","Asymptomatic overdose","epidemiology","mortality","2024-11-14",{"date":689,"type":32},"2024-11-18",{"date":691,"type":32},"2021-01-01",{"date":693,"type":21},"2025-09",{"name":695,"class":74},"Centre Hospitalier Universitaire de Besancon",{"id":697,"slug":698,"hasResults":12,"nctId":699,"briefTitle":700,"officialTitle":701,"acronym":702,"eligibilityCriteria":703,"healthyVolunteers":12,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":704,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":705,"conditions":706,"keywords":710,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":717,"lastUpdatePostDateStruct":718,"startDateStruct":720,"completionDateStruct":722,"leadSponsor":724,"locationsCount":75},"100539505","effects-of-bothrops-spp-snake-envenomation-on-willebrand-factor-activity-in-martinique-and-french-guiana-100539505","NCT06304714","Effects of Bothrops Spp. Snake Envenomation on Willebrand Factor Activity in Martinique and French Guiana","Abnormalities of Plasma Willebrand Factor Activity Induced by Bothrops Snakebites Endemic to Martinique and French Guyana","WBOTHROPS","Inclusion Criteria:\n\n* Men or Women, at least 18 years old\n* Be admitted to the Emergency Department of the Martinique University Hospital or the Cayenne University Hospital\n* Be the victim of a confirmed Bothrops snake bite in Martinique or French Guyana. The formal identification of the snake by the patient or his entourage is imperative.\n* Have a confirmed diagnosis of stage III envenomation (regional oedema of the limb and\u002For moderate general symptoms such as moderate hypotension, malaise, vomiting, abdominal pain, diarrhoea) and stage IV (extensive oedema reaching the trunk and\u002For severe general symptoms such as prolonged hypotension, shock, anaphylactoid reaction, visceral damage)\n* Be able to receive and understand information related to the research\n* Be able to freely give verbal consent to participate in the proposed research\n* Be able to freely give written informed consent to participate in the plasmathèque\n* Be affiliated to the general social security system\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding woman\n* People who have been treated for snakebite with Bothrops anti-venom Bothrofav® or Antivipmyn-tri®.\n* Known disorders of haemostasis such as haemophilia A (factor VIII deficiency), haemophilia B (factor IX deficiency), vitamin K deficiency, hepato-cellular insufficiency, presence of circulating anticoagulant factors\n* Disseminated intravascular coagulation (DIC)\n* Constitutional and acquired Von Willebrand disease\n* Constitutional and acquired thrombopathies\n* Idiopathic thrombocytopenic purpura\n* Person under legal protection (guardianship, curatorship, safeguard of justice), and person deprived of liberty.",{"count":187,"type":21},"In 2017, the World Health Organization placed snakebites at the top of its list of neglected tropical diseases in an effort to facilitate funding for prevention programs, improve access to anti-venom, and stimulate new research in this area. Between 5 and 25 cases per 100 000 inhabitants are reported per year in French Guiana and Martinique. Before the era of anti-venom immunotherapy, envenomations by Bothrops snake bites in French Guiana and Martinique could quickly become life-threatening with a mortality rate close to 30%. Today, the administration of fragments of Fab or (Fab')2 immunoglobulins gives anti-venoms an excellent capacity to neutralise venom toxins, which has reduced mortality to less than 1% in the case of early hospital treatment In French Guiana, envenomation by Bothrops bites is characterized by local signs such as intense pain, rapidly expanding oedema, haemorrhagic phlyctenes and sometimes muscle necrosis. The local inflammatory and haemorrhagic damage is related to the enzymatic activities of the toxins contained in the venom (metallo-proteinases, disintegrins, and phospholipases A2, in particular). At the systemic level, venom serine proteases and metalloproteinases activate the coagulation cascade by multiple mechanisms (activation of coagulation factors X and V and of protrombin, thrombin-like and fibrinogenolytic enzymatic properties) and are responsible for the collapse of coagulation factors making the blood incoagulable. The metalloproteinases \"hemorrhagins\" destroy the vessel wall and are the cause of locoregional and systemic hemorrhage.\n\nEnvenomations by bites of Bothrops lanceolatus in Martinique have particular characteristics. Despite the genetic similarity with their congeners in French Guiana, envenomation by bites of Bothrops lanceolatus is characterized by the development of very intense local inflammatory signs (little haemorrhage) and the occurrence of thrombotic complications such as cerebral, pulmonary or myocardial infarction. The mechanisms behind this thrombotic presentation are not known. The large amount of metalloproteinases in the composition of Bothrops lanceolatus venom is believed to be responsible for destruction of vascular endothelium and pro-thrombotic state. Bothrops lanceolatus bite envenomations have been reported to be frequently complicated by generalized infections, disseminated intravascular coagulation and the occurrence of multi-visceral failure syndrome. This observation suggests abnormalities in endothelial function in which changes in Willebrand factor expression have been implicated.\n\nThe investigators hypothesize that plasma Willebrand factor (VW) activity and the intensity of endothelial activation are different depending on the Bothrops snake species involved in the bites in Guyana and Martinique. Due to the specific properties of the venoms of each Bothrops species, the activity of the Willebrand factor (VW) and the consequences in terms of endothelial activation would be different and responsible for the clinico-biological characteristics according to the geographical origin of the snakes.\n\nThe investigators will demonstrate that the accumulation of Willebrand factor (VW) and the increase in its activity are responsible for the endothelial activation and micro-thrombosis observed during envenomations by Bothrops lanceolatus bites, whereas the decrease in its activity induced by the venoms of endemic Bothrops from Guyana is responsible for haemorrhagic phenomena.\n\nThis study will highlight the importance of changes in Willebrand factor activity on endothelial activation and the initiation of micro-thrombosis in the case of Bothrops lanceolatus envenomations and on primary haemostasis and bleeding disorders in the case of endemic Bothrops in Guyana. This new knowledge is important insofar as individualised therapeutic management can be proposed. Indeed, several studies have shown that adjuvant treatment of thrombotic microangiopathies, such as thrombotic thrombocytopenic purpura, with blood products (fresh frozen plasma) or plasma exchange, improves endothelial dysfunction and the prognosis of patients.",[707,708,709,27],"Snake Envenomation","Thrombi","Coagulopathy",[711,712,713,714,715,716],"Snakebite envenomation","French Caribbean (Martinique, French Guiana)","Bothrops species","Von Willebrand Factor","endothelial activity","haemostasis","2024-09-24",{"date":719,"type":32},"2024-09-26",{"date":721,"type":32},"2024-08-02",{"date":723,"type":21},"2025-10-08",{"name":725,"class":74},"University Hospital Center of Martinique",{"id":727,"slug":728,"hasResults":12,"nctId":729,"briefTitle":730,"officialTitle":730,"acronym":4,"eligibilityCriteria":731,"healthyVolunteers":12,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":732,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":734,"conditions":735,"keywords":736,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":739,"lastUpdatePostDateStruct":740,"startDateStruct":742,"completionDateStruct":744,"leadSponsor":745,"locationsCount":75},"100283654","pharmacogenomics-of-warfarin-in-hispanics-and-latinos-100283654","NCT02972385","Pharmacogenomics of Warfarin in Hispanics and Latinos","Inclusion Criteria:\n\n* At least 18 years of age\n* Ability to give informed consent\n* Therapeutic INR for at least 2 consecutive clinic visits\n* Self-identifies as Hispanic or Latino\n\nExclusion Criteria:\n\n* Less than 18 years old\n* Unable to give informed consent\n* Severe hepatic impairment",{"count":733,"type":21},400,"Warfarin is a commonly used blood thinner to treat and prevent blood clots. It is important to take the right dose of warfarin because too much can increase the risk of bleeding and too little can increase the risk of blood clots. This is why patients are closely monitored especially when they begin warfarin therapy. When clinicians prescribe warfarin, they have to consider different factors such as patient's age, body size, diet, and other medications that can interact with warfarin.\n\nCertain genes have also been found to affect warfarin dose. Individuals have variations in these genes, which can help explain why some patients need higher dose and others require less. These factors have been used to better predict a patient's warfarin dose requirement. However, these predictions were created based on Caucasian populations and they may not be accurate in predicting a safe warfarin dose if a patient is not Caucasian. This study aims to identify new genetic variation that affects warfarin dosing in Hispanic and Latino populations and try to better predict a Hispanic or Latino patient's warfarin dose requirement.",[57,27],[737,738],"warfarin","blood clotting","2024-06-25",{"date":741,"type":32},"2024-06-27",{"date":743,"type":32},"2016-09",{"date":69,"type":21},{"name":746,"class":74},"University of Arizona"]