[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"intracranial-hemorrhages\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:intracranial-hemorrhages":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,19,0,[8,54,79,108,148,169,191,235,264,291,321,349,377,399,428,450,471,503,527],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":37,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100644087","efficacy-and-safety-of-antihypertensive-treatment-with-mobile-stroke-units-in-ultra-early-intracerebral-hemorrhage-100644087",false,"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.","ALL","18 Years",{"count":20,"type":21},706,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28,29,30,31,32,33,34,35,36],"Nervous System Diseases","Cerebrovascular Disorders","Cardiovascular Diseases","Vascular Diseases","Hemorrhage","Intracranial Hemorrhages","Cerebral Hemorrhage","Cerebral Hemorrhage, Hypertensive","Stroke","Hemorrhagic Stroke, Intracerebral",[38,39,40],"intracerebral hemorrhage","mobile stroke units","Intensive blood pressure lowering","NOT_YET_RECRUITING","2026-06-18",{"date":44,"type":45},"2026-06-24","ACTUAL",{"date":47,"type":21},"2026-06",{"date":49,"type":21},"2028-07",{"name":51,"class":52},"Xuanwu Hospital, Beijing","OTHER",1,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":61,"enrollmentInfo":62,"targetDuration":4,"studyType":22,"phases":64,"briefSummary":66,"conditions":67,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":4},"100569583","phase-1-tenecteplase-tnk-in-the-treatment-of-intracerebral-hemorrhage-ich-100569583","NCT06696131","Tenecteplase (TNK) in the Treatment of Intracerebral Hemorrhage (ICH)","TNK in ICH","Inclusion Criteria\n\n* Patient\u002Flegally authorized representative has signed the Informed Consent Form.\n* Ability to comply with the study protocol, in the investigator's judgment.\n* Patients 18 to 80 years of age with an ICH had occurred within 24 hours before admission.\n* Spontaneous supratentorial (basal ganglia, thalamus, lobar) ICH ≥30 mL measured utilizing the ABC\u002F2 method.\n* Subjects with a GCS score of 5-14.\n* NIHSS ≥6.\n* Stability CT scan done at least 6 hours after baseline CT showing clot stability (growth \\\u003C5 mL as measured by ABC\u002F2 method). If the hematoma volume measured on the stability CT scan increases by 5 mL or more, a second stability CT scan will be performed 12 hours later.\n* Sustained systolic blood pressure (SBP) \\\u003C180 mm Hg for six hours recorded closest to the time of drug administration.\n* Symptoms must be present less than 24 hours prior to baseline CT scan.\n* Baseline Rankin score of 0 or 1.\n\nExclusion Criteria\n\n* Presence of infratentorial parenchymal bleeding.\n* Presence of a hemorrhage extending to the midbrain.\n* An unknown time of onset or the symptoms onset more than 24 hours prior to admission.\n* Pregnancy.\n* Inability to obtain written informed consent from subject or legal representative.\n* Sustained SBP \\>180 mm Hg for six hours recorded closest to the time of drug administration.\n* Age \\\u003C18 and \\>80 years.\n* Radiological evidence of arterio-venous malformation, aneurysm, amyloid angiopathy, Moyamoya disease, hemorrhagic conversion of an ischemic stroke, recurrent hemorrhage in the same location within the past 365 year or unstable mass as a source for the ICH.\n* Evidence of coagulopathy (international normalized ratio \\>1.3; platelet count \\\u003C100 ,000 or platelet dysfunction P2Y-12 \\>250) or known clotting disorder.\n* Bilateral fixed, dilated pupils indicating irreversible impaired brain stem function with GCS ≤4.\n* Patients with severe ICH and IVH who require an external ventricular drain (EVD) placement for cerebrospinal fluid (CSF) diversion or separate intraventricular thrombolysis.\n* Inability to maintain INR less than 1.3.\n* Use of anticoagulants prior to symptom onset and subjects requiring long-term anticoagulants (the reversal is permitted if the patient can tolerate the short-term risk of reversal).\n* Use of Dabigatran, Apixaban, and\u002For Rivaroxaban (or a similar medication from the similar medication class) prior to symptom onset.\n* Internal bleeding (GI, renal, respiratory etc).\n* Mechanical heart valve (Bioprosthetic heart valve is permitted).\n* Known risk for embolization, including history of left heart thrombus, mitral stenosis with atrial fibrillation, acute pericarditis, or subacute bacterial endocarditis (atrial fibrillation without mitral stenosis is permitted).\n* Allergy or sensitivity to TNKase.\n* Participation in a concurrent clinical trial.\n* Serious illness (advanced stage which can interfere with the outcome).\n* The patient is unstable and would not benefit from a surgical intervention.\n* GCS score of 3-4 and 15 (to ensure patient safety and study feasibility).\n* Historical mRS score of 2-6 (at admission).\n* Symptomatic tract hemorrhage or a tract hemorrhage more than 5 mm.","80 Years",{"count":63,"type":21},5,[65],"PHASE1","The overall purpose of this study is to look at the safety and effectiveness of administering Tenecteplase (TNK) into the brain bleed (hematoma) instead of another clot-dissolving drug known as recombinant tissue plasminogen activator (rtPA), which is the current standard practice. Clot dissolving (Fibrinolytic) drugs work to break down blood clots and have been found to improve health outcomes when applied directly into the hematoma within the brain. Patients who take part in this study will undergo the same surgical procedure that would normally be performed to treat them, but with the exception of TNK not rtPA.",[68,32,69],"Intracerebral Hemorrhage","Hemorrhagic Strokes","2026-04-24",{"date":72,"type":45},"2026-04-30",{"date":74,"type":21},"2026-09-15",{"date":76,"type":21},"2028-12-31",{"name":78,"class":52},"Gaurav Gupta, MD",{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":87,"sex":17,"minAge":18,"maxAge":88,"enrollmentInfo":89,"targetDuration":4,"studyType":91,"phases":4,"briefSummary":92,"conditions":93,"keywords":97,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":53},"100618958","efficacy-and-feasibility-trial-of-a-portable-near-infra-red-hematoma-imager-nird-hi-100618958","NCT07338383","Efficacy and Feasibility Trial of a Portable Near Infra-Red Hematoma Imager (NIRD-HI)","An Efficacy and Feasibility Trial of a Portable Near Infra-Red Hematoma Imager for Detection of Intracranial Hemorrhage in the Acute Care Setting","NIRD-HI","Inclusion Criteria:\n\n* 18 to 89 years of age\n* Able to provide written informed consent either by self or legally authorized representative\n* Received head CT imaging on admission\n* Able to complete at least one NIRD-HI scan within 4 hours of head CT\n* Non-operative management planned\n\nExclusion Criteria:\n\n* Presence of penetrating or non-survivable injuries\n* Hemorrhagic shock or large volume transfusion \\[\\>3 units of any blood product within\n\n  1 hour of scan\\]\n* Large open skull wounds, scalp lacerations or surface hematomas prohibiting safe or comfortable sensor placement\n* Presence of heat tattoos or intracranial metal fixtures\n* Cervical injury prolonging C-spine collar\n* Known prisoners or wards of state\n* Any condition or finding that makes the patient unsuitable for image acquisition in the Investigator's opinion",true,"89 Years",{"count":90,"type":21},80,"OBSERVATIONAL","Traumatic Brain Injury (TBI) is a leading cause of death and disability among military personnel, Veterans, and civilians. One of the most dangerous complications of moderate-to-severe TBI is intracranial hemorrhage (ICH). If not identified and treated promptly, ICH can rapidly lead to worsening neurological damage or death. Current diagnostic tools, such as CT scans, are highly effective but impractical for battlefield or resource-limited environments due to their large size and infrastructure dependency.\n\nThe Near-Infrared Detection-Head Imaging (NIRD-HI) system is an innovative, noninvasive device using Near-Infrared Spectroscopy (NIRS) to identify abnormal blood accumulation. Unlike traditional tools, NIRD-HI is compact, lightweight, and portable, making it suitable for remote or austere settings. By dynamically imaging the brain, it generates 3D visualizations that pinpoint the size and location of bleeds, including complex bilateral injuries. This offers a significant improvement over current point-of-injury technologies that lack the resolution to reliably diagnose all forms of ICH.\n\nThis study supports the FY24 Combat Readiness Medical Research Program by advancing battlefield diagnostic and triage capabilities. The research will:\n\n* Evaluate NIRD-HI's accuracy compared to CT imaging.\n* Assess feasibility in real-world acute care settings.\n* Investigate its ability to monitor changes in ICH over time.\n\nThese objectives address the military's need for tools that improve rapid diagnosis and decision-making during emergencies. Implementing this research can revolutionize TBI management. For Service Members, NIRD-HI promises a field-ready solution for early detection, enabling faster intervention and more effective triage. By reducing diagnostic delays, it could save lives and prevent long-term complications. Furthermore, the system supports prolonged field care by providing continuous monitoring of evolving injuries.\n\nThe benefits extend to civilian healthcare, particularly in rural or underserved areas lacking advanced imaging. This accessibility can improve trauma care outcomes for millions, reduce the burden on healthcare systems, and provide equitable distribution of life-saving technology. By addressing gaps in battlefield medicine, this project aims to enhance medical readiness and improve survivability in the most challenging environments.",[94,32,95,96],"Traumatic Brain Injury","Combat Casualty Care","Point of Care",[94,98,85],"Intracranial Hemorrhage","2026-01-05",{"date":101,"type":45},"2026-01-13",{"date":103,"type":21},"2026-01-01",{"date":105,"type":21},"2027-09-29",{"name":107,"class":52},"The Geneva Foundation",{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":114,"eligibilityCriteria":115,"healthyVolunteers":11,"sex":17,"minAge":116,"maxAge":117,"enrollmentInfo":118,"targetDuration":4,"studyType":91,"phases":4,"briefSummary":120,"conditions":121,"keywords":131,"overallStatus":137,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":147},"100544564","screening-emotions-in-adolescents-at-the-hospital-for-mtbi-100544564","NCT06370520","Screening Emotions in Adolescents at the Hospital for mTBI","Screening Emotions in Adolescents Receiving Care at the Hospital for mTBI (SEARCH-mTBI)","SEARCH-mTBI","Inclusion Criteria:\n\nChildren 11 to less than 18 years old who meet the Centers for Disease Control and Prevention (CDC) definition of mTBI\\*. In brief, this is defined as a Glasgow Coma Scale (GCS) score of 13 to 15 with:\n\n\\- Head injury (e.g., direct blow or sudden deceleration\u002Facceleration) plus any neurological sign and\u002For symptom such as headache, nausea, history of loss of consciousness, confusion, dizziness, amnesia (not limited to these symptoms\u002Fsigns)\n\nAND\u002FOR\n\n\\- Traumatic intracranial abnormalities on CT or MRI (such as intracranial hemorrhage, skull fracture, or diffuse axonal injury)\n\n\\*mTBI is defined as an acute brain injury resulting in neurological symptoms such as confusion or disorientation, headache, nausea, loss of consciousness, amnesia, seizure, focal signs or symptoms, and\u002For have traumatic intracranial abnormalities on CT or MRI imaging. mTBI patients have GCS scores of 13 to 15. Per CDC precedent, we will use the term mTBI which encompasses other commonly used terms such as \"concussion\" or \"minor head injury\". This will include patients who may have neuroimaging findings of traumatic abnormalities (e.g., intracranial hemorrhage, diffuse axonal injury, skull fractures) which are risk factors for mental health problems; however, neuroimaging is not required for enrollment into the study.\n\nExclusion Criteria:\n\n* Presentation to the ED \\>72 hours post-injury\n* TBI requiring emergent neurosurgical intervention at the time of enrollment\n* Other injuries requiring emergent surgery at the time of enrollment\n* Parent or child unable to accurately complete the study questionnaires due to preexisting functional limitations (e.g., severe developmental delay)\n* Previous known enrollment into the study\n* Patient or parent does not speak English or Spanish","11 Years","17 Years",{"count":119,"type":21},2592,"The goal of this observational study is to develop and validate a clinical tool to predict which adolescents aged 11 to less than 18 years of age with mild traumatic brain injury (mTBI) are at an increased risk for developing significant new or worsening mental health conditions.\n\nThe main aims the study wish to answer are:\n\n* Does the adolescent have new or worsening depression or anxiety defined as a change from their previous medical history using self-reported questionnaires at either one or three months post-injury?\n* Does the adolescent have unmet mental health care needs, defined as not receiving any mental or behavior health care in patients with new or worsening anxiety or depression as defined by the self reported questionnaires?\n\nParticipants will be enrolled after being diagnosed in the emergency department (ED) with an mTBI. During the ED visit, the child's parent\u002Fcaregiver and the adolescent will complete several questionnaires related to mental health which include tools to measure anxiety and depression. Participants will be asked to complete these questionnaires again at 1 month and 3 months post enrollment.",[122,123,124,125,126,127,128,129,32,130],"Brain Injury Traumatic Mild","Brain Injuries","Brain Injuries, Acute","Head Injury With Intracranial Hemorrhage","Head Injury Trauma","Brain Injury Traumatic Focal With Loss of Consciousness","Skull Fractures","Diffuse Axonal Injury","Head Injury",[132,133,134,123,135,136],"Child","Concussion","Wounds and Injuries","Head Injuries Trauma","Loss of Consciousness","RECRUITING","2025-09-22",{"date":140,"type":45},"2025-09-26",{"date":142,"type":45},"2024-05-22",{"date":144,"type":21},"2028-12",{"name":146,"class":52},"University of California, Davis",6,{"id":149,"slug":150,"hasResults":11,"nctId":151,"briefTitle":152,"officialTitle":152,"acronym":153,"eligibilityCriteria":154,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":155,"targetDuration":4,"studyType":91,"phases":4,"briefSummary":157,"conditions":158,"keywords":4,"overallStatus":137,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":53},"100606435","safety-and-efficacy-of-aneurysms-treated-with-endovascular-devices-100606435","NCT07175519","Safety and Efficacy of Aneurysms Treated With Endovascular Devices","SEATED","Inclusion Criteria:\n\n* All patients undergoing endovascular aneurysm treatment.\n\nExclusion Criteria:\n\n* All endovascular patients NOT undergoing aneurysm treatment e.g. stents used for stroke treatment; devices and materials used for dAVF, AVM treatments.\n* Insufficient background data available e.g., to determine size of aneurysm and device.",{"count":156,"type":21},5000,"In this project the investigators study the safety and efficacy of the recent endovascular devices used in treatment of brain aneurysms.",[159,35,32],"Brain Aneurysm","2025-09-08",{"date":162,"type":45},"2025-09-16",{"date":164,"type":45},"2025-01-15",{"date":166,"type":21},"2035-01-15",{"name":168,"class":52},"King's College London",{"id":170,"slug":171,"hasResults":11,"nctId":172,"briefTitle":173,"officialTitle":174,"acronym":175,"eligibilityCriteria":176,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":61,"enrollmentInfo":177,"targetDuration":4,"studyType":91,"phases":4,"briefSummary":179,"conditions":180,"keywords":4,"overallStatus":137,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":183,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":53},"100397798","intracranial-pressure-time-dose-impeto-100397798","NCT04459806","Intracranial PrEssure Time dOse (ImPETO)","Evaluation of Intracranial Pressure Time Dose by the New Integra CereLink ICP Monitor","ImPETO","Inclusion Criteria:\n\n* Aged within 18 and 80 years;\n* Diagnosed of an acute brain injury (ABI) for hemorrhagic stroke (including intracerebral hematoma or subarachnoid hemorrhage) or traumatic brain injury;\n* ICP monitoring started for clinical indication and accordingly to local policies\n* ICP device connected to the Integra CereLink ICP monitor.\n\nExclusion Criteria:\n\n* ICP monitoring not inserted\n* No availability of the Integra CereLink ICP monitor.",{"count":178,"type":21},250,"The new Integra CereLink ICP monitor integrate the possibility of recording and displaying continuously the AUC (Pressure Time Dose, PTD) and other ICP derived variables and provide the possibility of evaluating the utility of this information at the bedside. It offers the opportunity to test in a standardized way the clinical value of the PTD computation in this setting.\n\nTherefore, this study aims to test clinically if PTD recorded continuously is associated to patients' outcome and to identify a threshold of PTD associated with the transition from good to negative outcomes.",[181,94,182,32],"Intracranial Hypertension","Subarachnoid Hemorrhage",{"date":184,"type":45},"2025-09-15",{"date":186,"type":45},"2023-11-13",{"date":188,"type":21},"2026-12-31",{"name":190,"class":52},"University of Milano Bicocca",{"id":192,"slug":193,"hasResults":11,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":197,"eligibilityCriteria":198,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":199,"targetDuration":4,"studyType":22,"phases":201,"briefSummary":203,"conditions":204,"keywords":212,"overallStatus":137,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":226,"startDateStruct":228,"completionDateStruct":230,"leadSponsor":232,"locationsCount":234},"100583572","phase-3-thrombolysis-in-factor-xa-inhibitors-trial-100583572","NCT06878066","Thrombolysis in Factor Xa-inhibitors Trial","The Efficacy and Safety of Intravenous Thrombolysis in Acute Ischemic Stroke Patients With Recent Ingestion of Factor Xa-inhibitors Trial (SIFT)","SIFT","Inclusion Criteria:\n\n1. Participant must be 18 years of age or older.\n2. Ingestion of FXa inhibitors within the last 48 hours of symptom onset (or ongoing prescription of FXa inhibitor if unknown)\n3. Clinical diagnosis of AIS with disabling neurological deficit\n4. Presenting within 4.5 h of symptom onset or after awakening with symptoms of AIS with FLAIR-DWI mismatch on MRI as judged by the (neuro-) radiologist.\n5. Informed consent\n\nExclusion Criteria:\n\n1. Endovascular treatment eligible patients with isolated large vessel occlusion of the intracranial internal carotid artery (ICA), the M1 segment of the middle cerebral artery (MCA), or both confirmed by CT or MR angiography and expected time from randomization to groin puncture of \\\u003C30 minutes.\n2. Systolic BP \\>185 mmHg or diastolic BP \\>110 mmHg despite antihypertensive treatment.\n3. Known bleeding diathesis; manifest or recent severe bleeding; significant bleeding disorder last 6 months.\n4. Arterial puncture at a non-compressible site; biopsy or lumbar puncture \\\u003C7 days; major surgery, traumatic external heart massage, obstetrical delivery or serious trauma \\\u003C14 days; history of intracranial haemorrhage; stroke \\\u003C2 months, CNS neurosurgery \\\u003C2 months; serious head trauma \\\u003C2 months; pericarditis; sepsis; bacterial endocarditis; pericarditis; acute pancreatitis; neoplasm with increased bleeding risk; any serious medical illness likely to interact with treatment (i.e. aortic dissection); confounding pre-existent neurological or psychiatric disease.\n5. Any condition that, in the opinion of the treating physician, puts a patient at risk if treated with thrombolysis (i.e. signs of cerebral hemorrhage, known cerebral amyloid angiopathy, CT with signs of early ischemia greater than one-third of the middle cerebral artery territory).\n\n   Prior\u002FConcomitant Therapy\n6. Use of a) direct thrombin (II) inhibitor (Dabigatran) or b) warfarin with an INR ≥1.8; c) heparin \\\u003C48 h; d) treatment dose of LMWH \\\u003C24 h.\n\n   Prior\u002FConcurrent Clinical Study Experience\n7. Hypersensitivity to Alteplase or Tenecteplase",{"count":200,"type":21},300,[202],"PHASE3","This study looks at whether stroke patients who take FXa inhibitors (a type of blood thinner) can safely receive clot-busting treatment (IVT). IVT is a common emergency treatment for stroke, but current guidelines say it should not be given to people who have taken FXa inhibitors in the last 48 hours. This is because doctors worry that IVT might cause dangerous bleeding in the brain.\n\nHowever, new research suggests that IVT might be safe for these patients. Some studies even show that stroke patients on FXa inhibitors who receive IVT do not have a higher risk of brain bleeding than other stroke patients. But because these studies were not designed as full medical trials, doctors still avoid IVT for this group.\n\nThe SIFT trial will compare two groups of stroke patients who take FXa inhibitors:\n\nOne group will receive IVT to see if it helps them recover better. One group will not receive IVT, which is the current standard. Doctors will check if IVT helps with recovery and if it causes any serious bleeding. If IVT is found to be safe and effective, this study could change stroke treatment guidelines and help more patients get life-saving care.\n\nRight now, some guidelines say that stroke patients on FXa inhibitors should have a blood test before getting IVT, to measure how much of the drug is in their system. But these tests are not available in most hospitals, and waiting for results could delay important treatment. The SIFT trial will not require this test before giving IVT.\n\nMore and more people use FXa inhibitors to prevent strokes, but right now, they are being denied IVT based on old rules. If this study proves that IVT is safe for them, it could help doctors give better care to thousands of stroke patients.",[35,205,206,207,208,209,32,210,211],"Stroke (in Patients With Atrial Fibrillation)","Ischemic Stroke","Acute Ischemic Stroke","Anticoagulant Therapy","Factor Xa Inhibitor","Hemorrhagic Transformation Due to Acute Stroke","Bleeding in the Brain",[213,207,206,214,215,216,217,218,219,220,221,35,222,223,224],"Thrombolysis","Factor Xa Inhibitors","Atrial Fibrillation-Related Stroke","Intravenous Thrombolysis","Tissue Plasminogen Activator","Tenecteplase","Alteplase","Symptomatic Intracranial Hemorrhage","SIFT Trial","Acute stroke","Direct Oral Anticoagulants","DOACs","2025-08-29",{"date":227,"type":45},"2025-09-02",{"date":229,"type":45},"2025-03-14",{"date":231,"type":21},"2037-12-31",{"name":233,"class":52},"Guri Hagberg",13,{"id":236,"slug":237,"hasResults":11,"nctId":238,"briefTitle":239,"officialTitle":240,"acronym":241,"eligibilityCriteria":242,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":243,"targetDuration":4,"studyType":22,"phases":245,"briefSummary":246,"conditions":247,"keywords":250,"overallStatus":137,"whyStopped":4,"lastUpdateSubmitDate":255,"lastUpdatePostDateStruct":256,"startDateStruct":257,"completionDateStruct":259,"leadSponsor":261,"locationsCount":263},"100385439","comparison-of-laa-closure-vs-oral-anticoagulation-in-patients-with-nvaf-and-status-post-intracranial-bleeding-100385439","NCT04298723","Comparison of LAA-Closure vs Oral Anticoagulation in Patients With NVAF and Status Post Intracranial Bleeding.","Randomized Comparison of Interventional Closure of the Left Atrial Appendage Using a LAA Closure Device Versus Oral Anticoagulation Therapy in Patients With Non-valvular Atrial Fibrillation and Status Post Intracranial Bleeding.","CLEARANCE","Inclusion Criteria:\n\n* Signed written informed consent\n* Documented atrial fibrillation (paroxysmal, persistent, long-standing persistent or permanent)\n* CHA2DS2VASc-Score ≥2\n* Status post intracranial bleeding \\>6 weeks\n* Favorable LAA anatomy\n* Subject eligible for a LAA occluder device\n* Age ≥18 years\n\nExclusion Criteria:\n\n* Comorbidities other than AF requiring chronic (N)OAC therapy, e.g. mechanical heart valve prosthesis, hereditary thrombophilia requiring livelong OAC - recurrent thrombosis\n* Symptomatic carotid disease (if not treated)\n* Thrombus in the left atrium or left atrial appendage\n* Active infection or active endocarditis or other infections resulting in bacteremia\n* Functional Impairment (modified ranking scale ≥4 )\n* Severe liver failure (Child-Pugh class C or liver failure with coagulopathy)\n* Pregnancy or breastfeeding\n* Subject with participation in another interventional clinical trial during this study or within 30 days before entry into this trial.\n* Known terminating disease with life expectancy \\\u003C1 year (including those with end-stage heart failure)\n* Subjects, who are committed to an institution due to binding official or court order\n* Subjects with planned cardiac or non-cardiac surgery or intervention. (These subjects can be included 30 days after intervention \u002F surgery",{"count":244,"type":21},530,[24],"Atrial fibrillation is the most common cardiac arrhythmia. In atrial fibrillation, there is a risk that clots can form in the heart, especially in the left atrium. If these clots come loose, there is a risk of stroke. To prevent strokes, patients with atrial fibrillation and status post ICB can be treated with anticoagulants. This medication therapy prevents blood clots from forming in the heart, but can also cause bleeding. Another therapy option is the occlusion of the left atrium. After closure of the left atrium, only a short anticoagulation therapy is necessary until the occluder has healed. The aim of the study is to compare these two treatment approaches. In this study only already approved drugs and occlusion systems will be used.",[32,248,249],"Atrial Fibrillation (AF)","Atrial Flutter",[98,251,252,253,254],"Intracranial Bleeding","Atrial Fibrillation","Anticoagulation","LAA Occlusion","2025-08-25",{"date":227,"type":45},{"date":258,"type":45},"2020-06-16",{"date":260,"type":21},"2029-12",{"name":262,"class":52},"Jena University Hospital",33,{"id":265,"slug":266,"hasResults":11,"nctId":267,"briefTitle":268,"officialTitle":269,"acronym":4,"eligibilityCriteria":270,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":61,"enrollmentInfo":271,"targetDuration":4,"studyType":91,"phases":4,"briefSummary":273,"conditions":274,"keywords":279,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":282,"lastUpdatePostDateStruct":283,"startDateStruct":285,"completionDateStruct":287,"leadSponsor":289,"locationsCount":4},"100601819","development-and-validation-of-a-prognostic-model-for-neurocritical-patients-using-multimodal-brain-monitoring-100601819","NCT07115459","Development and Validation of a Prognostic Model for Neurocritical Patients Using Multimodal Brain Monitoring","Protocol for Developing and Validating a Multimodal Brain Monitoring-Based Prognostic Model for Neurocritical Patients: A Prospective, Observational, Multicenter Cohort Study","Inclusion Criteria:\n\n1. Aged 18-80 years, no gender restrictions.\n2. Diagnosed with acute brain injury (ABI), including one of the following: large cerebral infarction, supratentorial large-volume intracerebral hemorrhage, subarachnoid hemorrhage, or severe traumatic brain injury, with imaging evidence (CT or MRI) supporting the diagnosis.\n3. On ICU admission, Glasgow Coma Scale (GCS) eye response = 1 (no eye opening) and motor score ≤ 5 (does not follow commands); or within 48 hours, neurological deterioration with no eye opening and motor score reduced to ≤ 5 (total GCS score ≤ 8).\n4. Able to undergo continuous multimodal monitoring, with an expected ICU stay of ≥72 hours.\n5. Informed consent signed by the family or legal representative.\n\nExclusion Criteria:\n\n1. Confirmed brain death on admission or imaging showing irreversible brain herniation.\n2. Severe trauma unrelated to brain injury (e.g., multiple fractures, spinal cord injuries, or visceral rupture) that may interfere with brain function monitoring or outcome assessment.\n3. Pre-existing severe neurological disorders such as epilepsy, severe encephalopathy, or chronic intracranial conditions (e.g., brain tumors or hydrocephalus).\n4. Inability to perform multimodal monitoring due to technical issues (e.g., equipment failure or sensor installation problems).\n5. Predicted survival time \\\u003C24 hours after admission, or family members choose to withdraw treatment.\n6. Refusal to participate in the study by the patient or their legal representative.",{"count":272,"type":21},167,"This study aims to develop and validate a prognostic model for neurocritical patients using multimodal brain monitoring data. By combining data from various monitoring techniques such as EEG, TCD, and NIRS, this model will help predict 90-day outcomes (awake, comatose, or deceased) and support personalized treatment decisions. The study is observational and involves no experimental interventions.",[275,276,277,32,182,278],"Acute Brain Injury Coma","Neurocritical Care","Cerebral Infarction","Severe Traumatic Brain Injury",[280,281],"Multimodal Brain Monitoring","Prognostic Model","2025-08-03",{"date":284,"type":45},"2025-08-11",{"date":286,"type":21},"2025-08-15",{"date":288,"type":21},"2026-11-15",{"name":290,"class":52},"Xiangya Hospital of Central South University",{"id":292,"slug":293,"hasResults":11,"nctId":294,"briefTitle":295,"officialTitle":296,"acronym":297,"eligibilityCriteria":298,"healthyVolunteers":87,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":299,"targetDuration":4,"studyType":22,"phases":301,"briefSummary":302,"conditions":303,"keywords":305,"overallStatus":137,"whyStopped":4,"lastUpdateSubmitDate":312,"lastUpdatePostDateStruct":313,"startDateStruct":315,"completionDateStruct":317,"leadSponsor":319,"locationsCount":53},"100564700","timing-impact-of-early-vs-late-cranioplasty-on-hemicraniectomy-outcomes-100564700","NCT06632587","Timing Impact of Early vs. Late Cranioplasty on Hemicraniectomy Outcomes","Comparing Outcomes Between Early and Standard-of-care Delayed Cranioplasty After Decompressive Hemicraniectomy","TIMELY","Inclusion Criteria:\n\n* Adults of age greater than or equal to 18 years at the time of acute traumatic injury or source of increased intracranial pressure secondary to stroke or intracranial hemorrhage necessitating decompressive hemicraniectomy (DHC)\n* Patient's cranial flap fulfills Craniectomy Contour Class A or B after 4 weeks postoperatively (doi:10.1227\u002Fons.0000000000000689)\n* Medically optimized for general anesthesia\u002Fsurgery\n\nExclusion Criteria:\n\n* Active systemic infection in weeks 6-8 post-DHC leading up to cranioplasty (e.g. pneumonia, urinary tract infection, soft tissue infection, bacteremia)\n* Cranial infection in the post-DHC period\n* Patient deemed not appropriate for early cranioplasty by attending neurosurgeon\n* Patient mortality prior to 8 weeks post-injury (\"injury\" defined as \"acute traumatic injury or source of increased intracranial pressure causing brain injury secondary to stroke or intracranial hemorrhage\")",{"count":300,"type":21},44,[24],"This prospective, randomized study aims to comprehensively evaluate the impact of cranioplasty timing on postoperative complications and long-term functional outcomes following decompressive hemicraniectomy (DHC). The primary endpoint focuses on comparing the rates of various postoperative complications, including infection, seizures, return to the operating room, and the need for ventriculoperitoneal shunting, between patients undergoing standard of care cranioplasty (\\>3 months after DHC) and those receiving early cranioplasty (within 8 weeks).",[304,35,32],"Craniocerebral Trauma",[306,307,308,309,310,38,311],"Decompressive hemicraniectomy","cranioplasty","cranial trauma","stroke","intracranial hemorrhage","neurosurgery","2025-07-21",{"date":314,"type":45},"2025-07-23",{"date":316,"type":45},"2024-09-01",{"date":318,"type":21},"2027-09-01",{"name":320,"class":52},"Thomas Jefferson University",{"id":322,"slug":323,"hasResults":11,"nctId":324,"briefTitle":325,"officialTitle":326,"acronym":327,"eligibilityCriteria":328,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":61,"enrollmentInfo":329,"targetDuration":4,"studyType":22,"phases":331,"briefSummary":332,"conditions":333,"keywords":335,"overallStatus":137,"whyStopped":4,"lastUpdateSubmitDate":340,"lastUpdatePostDateStruct":341,"startDateStruct":343,"completionDateStruct":345,"leadSponsor":346,"locationsCount":348},"100599727","statins-for-treatment-of-primary-intracerebral-hemorrhage-100599727","NCT07088250","Statins for Treatment of Primary Intracerebral Hemorrhage","Statins for Treatment Of Primary IntraCerebral Hemorrhage (STOP ICH)","STOP ICH","Inclusion Criteria:\n\n* Patients with a diagnosis of spontaneous intracerebral hemorrhage (ICH) confirmed by computed tomography (CT);\n* Age 18-80 years;\n* Hematoma located in the supratentorial region;\n* Time from symptom onset or last known well to baseline CT ranging from 3 to 24 hours;\n* Atorvastatin treatment can be initiated within 48 hours of symptom onset or last known well;\n* Glasgow Coma Scale (GCS) score ≥9;\n* Baseline hematoma volume of 5-35 mL;\n* Signed informed consent obtained.\n\nExclusion Criteria:\n\n* ICH secondary to trauma, tumor, aneurysm, arteriovenous malformation (AVM), vascular anomaly, hemorrhagic transformation of infarction, cerebral venous thrombosis, or anticoagulant-related ICH;\n* Patients who have undergone or are scheduled for immediate surgical intervention;\n* Pregnancy or lactation;\n* Use of oral anticoagulants within 1 month prior to symptom onset;\n* Pre-stroke mRS \\>1;\n* Known allergy to statins, active liver disease, liver dysfunction, or rhabdomyolysis;\n* Known terminal illness with a pre-stroke life expectancy of less than three months, or patients with planned withdrawal of care.",{"count":330,"type":21},264,[24],"The STOP ICH trial is a multicenter, prospective, randomized, open-label, blinded end-point (PROBE) study designed to assess the efficacy and safety of atorvastatin in patients with intracerebral hemorrhage (ICH) presenting within 3 to 24 hours of symptom onset.",[28,32,98,334],"Intracerebral Haemorrhage",[336,337,338,339],"Intracerebral hemorrhage","Treatment","Atorvastatin","Outcome","2025-07-20",{"date":342,"type":45},"2025-07-28",{"date":344,"type":45},"2023-05-06",{"date":188,"type":21},{"name":347,"class":52},"The Second Hospital of Anhui Medical University",22,{"id":350,"slug":351,"hasResults":11,"nctId":352,"briefTitle":353,"officialTitle":354,"acronym":355,"eligibilityCriteria":356,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":357,"targetDuration":4,"studyType":91,"phases":4,"briefSummary":359,"conditions":360,"keywords":365,"overallStatus":137,"whyStopped":4,"lastUpdateSubmitDate":368,"lastUpdatePostDateStruct":369,"startDateStruct":371,"completionDateStruct":373,"leadSponsor":375,"locationsCount":53},"100564929","personalized-viscoelastic-testing-guided-bleeding-management-in-liver-surgery-neurosurgery-and-obstetrics-100564929","NCT06635564","Personalized ViscoElastic Testing-guided Bleeding Management In Liver Surgery, Neurosurgery and Obstetrics","Personalized ViscoElastic Testing-guided Bleeding Management In Liver Surgery, Neurosurgery and Obstetrics - a Prospective Comparison of the Novel ClotPro With ROTEM and TEG","VETILNO","Inclusion Criteria:\n\n1. Vulnerable patient cohorts\n\n   * Patients undergoing elective liver surgery defined as one of the following invasive procedures:\n\n     * Liver resection (anatomic or non-anatomic segmental resection, right or left hepatectomy, right or left extended hepatectomy),\n     * Orthotopic liver transplantation,\n   * Pregnant women undergoing an elective caesarean section, and\n   * Patients undergoing an elective intracranial neurosurgery.\n2. Written informed consent\n\nExclusion Criteria:\n\nnone",{"count":358,"type":21},240,"The ClotPro analyzer is a new generation viscoelastic analyzer for the in vitro assessment of blood coagulation. This study aims to assess the agreement of ClotPro 6.0, ROTEM delta, and TEG 6s in three distinct cohorts: i) patients with liver disease undergoing liver surgery, ii) pregnant women undergoing elective cesarean section, and iii) patients undergoing elective intracranial neurosurgery. Further coagulation tests will be performed (standard laboratory coagulation tests, thrombin and plasmin generation tests) in an exploratory fashion to compare them with viscoelastic test results. The obtained test results will not result in any diagnostic or therapeutic consequences for patients included in this study.",[361,362,363,364,32],"Thrombelastography","Liver Transplant","Postpartum Hemorrhage","Bleeding Disorder",[366,367],"Viscoelastic testing","personalized bleeding management","2025-05-20",{"date":370,"type":45},"2025-05-23",{"date":372,"type":45},"2024-07-01",{"date":374,"type":21},"2026-07-31",{"name":376,"class":52},"Medical University of Vienna",{"id":378,"slug":379,"hasResults":11,"nctId":380,"briefTitle":381,"officialTitle":382,"acronym":383,"eligibilityCriteria":384,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":385,"targetDuration":387,"studyType":91,"phases":4,"briefSummary":388,"conditions":389,"keywords":4,"overallStatus":137,"whyStopped":4,"lastUpdateSubmitDate":390,"lastUpdatePostDateStruct":391,"startDateStruct":393,"completionDateStruct":395,"leadSponsor":397,"locationsCount":53},"100540691","blandish-brain-loss-of-function-aneurism-disease-injury-stroke-hemorrhage-100540691","NCT06320132","BLANDISH (Brain, Loss of Function, Aneurism, Disease, Injury, Stroke, Hemorrhage)","BLANDISH (Brain, Loss of Function, Aneurism, Disease, Injury, Stroke, Hemorrhage): Design and Internal Validation of an AI System to Support and Optimize the Management of Spontaneous Intracranial Hemorrhage Patients in the NeuroICU","BLANDISH","Inclusion Criteria:\n\n* Patients who enter the NICU for acute spontaneous intracranial hemorrhage\n* Adult patients (≥ 18 years)\n* Sex: female, male, intersex\n\nExclusion Criteria:\n\n* All patients affected by non-spontaneous ICH\n* Patients with sICH determined by brain tumor or brain metastases\n* All patients affected by chronic ICH\n* Pregnant and puerperal women\n* Refusal to participate in the protocol",{"count":386,"type":21},2000,"14 Months","The goal of this observational study is to train a machine learning system based on data from patients affected by spontaneous Intracranial Hemorrage. The main question it aims to answer is whether there is a correlation between actual clinical pratice, reached outcomes and favorable or unfavorable predictive factors, and anamnesis.\n\nParticipants will be treated as per standard clinical practice.",[32],"2025-04-03",{"date":392,"type":45},"2025-04-06",{"date":394,"type":45},"2024-03-13",{"date":396,"type":21},"2029-01-31",{"name":398,"class":52},"IRCCS Ospedale San Raffaele",{"id":400,"slug":401,"hasResults":11,"nctId":402,"briefTitle":403,"officialTitle":404,"acronym":405,"eligibilityCriteria":406,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":61,"enrollmentInfo":407,"targetDuration":4,"studyType":91,"phases":4,"briefSummary":409,"conditions":410,"keywords":415,"overallStatus":137,"whyStopped":4,"lastUpdateSubmitDate":419,"lastUpdatePostDateStruct":420,"startDateStruct":422,"completionDateStruct":424,"leadSponsor":426,"locationsCount":53},"100513636","detection-of-microplastics-and-nanoplastics-in-neurosurgery-patients-dt-mini-100513636","NCT05968053","Detection of Microplastics and Nanoplastics in Neurosurgery Patients (DT-MiNi)","Presence of Microplastics and Nanoplastics in Neurosurgery Patients","DT-MiNi","Inclusion Criteria:\n\n* Age 18-80 years\n* Any type of neurosurgery\n\nExclusion Criteria:\n\n·refusal of the patient to participate",{"count":408,"type":21},500,"Plastic particles are a ubiquitous pollutant in the living environment and food chain, so far, plenty of studies have reported the internal exposure of microplastics and nanoplastics in human tissues and enclosed body fluids.\n\nNeurosurgery is the only department that can open the skull. In addition to blood and cerebrospinal fluid, there are brain tissue and tumors in the presence of lesions. Whether any of these microplastics and nanoplastics are present remains a mystery. This prospective observational study will harvest biological samples of neurosurgery patients.\n\nThe objective of this research is to be able to detect microplastics and nanoplastics on blood and operation samples of neurosurgery patients.",[411,412,413,32,414],"Carotid Artery Stenosis","Glioma","Intracranial Aneurysm","Brain Tumor",[416,417,413,418,411],"microplastics","nanoplastics","brain tumor","2025-01-21",{"date":421,"type":45},"2025-01-23",{"date":423,"type":45},"2023-09-25",{"date":425,"type":21},"2025-12-31",{"name":427,"class":52},"Beijing Tiantan Hospital",{"id":429,"slug":430,"hasResults":11,"nctId":431,"briefTitle":432,"officialTitle":432,"acronym":433,"eligibilityCriteria":434,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":435,"targetDuration":4,"studyType":22,"phases":436,"briefSummary":437,"conditions":438,"keywords":439,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":441,"lastUpdatePostDateStruct":442,"startDateStruct":444,"completionDateStruct":446,"leadSponsor":448,"locationsCount":53},"100322976","safety-and-efficacy-of-remote-ischemic-conditioning-in-patients-with-spontaneous-intracerebral-hemorrhage-100322976","NCT03484936","Safety and Efficacy of Remote Ischemic Conditioning in Patients With Spontaneous Intracerebral Hemorrhage","SERIC-sICH","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Supratentorial intracerebral hemorrhage confirmed by brain CT scan\n3. Functional independence prior to ICH, defined as pre-ICH mRS ≤ 1\n4. NIHSS score ≥ 4 and GCS ≥ 6 upon presentation\n5. Able to commence RIC treatment within 12 hours of stroke onset\n6. Signed and dated informed consent is obtained.\n\nExclusion Criteria:\n\n1. Definite evidence of secondary ICH, such as structural abnormality, brain tumor, thrombolytic drug, and other causes\n2. A very high likelihood that the patient will die within the next 24 hours on the basis of clinical and\u002For radiological criteria\n3. Already booked for surgical treatment\n4. Life expectancy of less than 90 days due to comorbid conditions\n5. Severe hematologic disease\n6. Concurrent use of anticoagulation drugs including Warfarin, dabigatran, rivaroxaban.\n7. Concurrent use of glibenclamide or nicorandil\n8. Any soft tissue, orthopedic, or vascular injury, wounds or fractures in healthy upper limb which may pose a contraindication for application of RIC\n9. Severe hepatic and renal dysfunction\n10. Platelet count \\\u003C100×10\\^9\u002FL\n11. Coagulopathy defined as INR,APTT,and PT beyond the upper limit of normal range\n12. Known pregnancy, or positive pregnancy test, or breastfeeding\n13. Patients being enrolled or having been enrolled in other clinical trial within 3 months prior to this clinical trial\n14. A high likelihood that the patient will not adhere to the study treatment and follow up regimen\n15. Patients unsuitable for enrollment in the clinical trial according to investigators decision making.",{"count":244,"type":21},[24],"The purpose of this study is to determine whether treatment with remote ischemic conditioning is of sufficient promise to improve outcome before conducting a larger clinical trial to examine its effectiveness as a treatment for intracerebral hemorrhage.",[32],[32,440],"remote ischemic conditioning","2024-10-01",{"date":443,"type":45},"2024-10-02",{"date":445,"type":21},"2026-03-15",{"date":447,"type":21},"2027-06-15",{"name":449,"class":52},"Yi Yang",{"id":451,"slug":452,"hasResults":11,"nctId":453,"briefTitle":454,"officialTitle":455,"acronym":4,"eligibilityCriteria":456,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":457,"targetDuration":459,"studyType":91,"phases":4,"briefSummary":460,"conditions":461,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":462,"lastUpdatePostDateStruct":463,"startDateStruct":465,"completionDateStruct":467,"leadSponsor":469,"locationsCount":4},"100561478","defining-volume-status-with-extracellular-water-measurement-in-patients-with-intracranial-hemorrhage-100561478","NCT06590688","Defining Volume Status with Extracellular Water Measurement in Patients with Intracranial Hemorrhage","Extracellular Water for Volume Status Characterization in Patients with Intracranial Hemorrhage","Inclusion Criteria:\n\n* Adults with intracranial hemorrhage admitted to ICU.\n\nExclusion Criteria:\n\n* Pregnancy, palliative care.",{"count":458,"type":21},10,"7 Days","The goal of this observational study is to learn about the influence of extracellular water on volume status in adult patients with intracranial hemorrhage presenting with hemodynamic instability. The main question it aims to answer is:\n\n• Can measurement of extracellular water contribute to the description of hemodynamic instability in adult patients with intracranial hemorrhage. Patients with intracranial hemorrhage admitted to intensive care will receive standard care with the addition of measurement of extracellular water.",[32],"2024-09-09",{"date":464,"type":45},"2024-09-19",{"date":466,"type":21},"2024-09-23",{"date":468,"type":21},"2026-12",{"name":470,"class":52},"Uppsala University",{"id":472,"slug":473,"hasResults":11,"nctId":474,"briefTitle":475,"officialTitle":475,"acronym":476,"eligibilityCriteria":477,"healthyVolunteers":87,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":478,"targetDuration":4,"studyType":91,"phases":4,"briefSummary":480,"conditions":481,"keywords":486,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":496,"lastUpdatePostDateStruct":497,"startDateStruct":499,"completionDateStruct":500,"leadSponsor":502,"locationsCount":53},"100555454","plasticizer-exposure-and-its-consequences-on-health-100555454","NCT06512298","Plasticizer Exposure and Its Consequences on Health","PEACH","TDTM:\n\n* Inclusion: Adult, homozygous ß-Thalassemia Major, transfusion dependency.\n* Exclusion: Plastic implants, chronic infectious disease, pregnancy.\n\nThalassemia Intermedia\u002FMinor:\n\n* Inclusion: Adult, homozygous\u002Fheterozygous ß-Thalassemia Intermedia\u002FMinor\n* Exclusion: Plastic implants, chronic infectious disease, pregnancy, transfusion dependency\n\nHealthy adults:\n\n* Inclusion: Adult\n* Exclusion: Chronic disease, plastic implants, infectious disease, pregnancy, anemia, medication-, drug-, or alcohol-abuse\n\nGlioma patients:\n\n* Inclusion: Adult, high\u002Flow-grade glioma, tumor larger then 3cm, resection with access to the ventricular system\n* Exclusion: Large intraventricular hemorrhage, plastic implants, infectious disease\n\nICU patients:\n\n* Inclusion: Adult, brain hemorrhage, external CSF drain from ventricle\n* Exclusion: intraventricular hemorrhage, plastic implants, ECMO, hemodialysis, infectious disease\n\nPatients undergoing diagnostic lumbar-puncture:\n\n* Inclusion: Adult, diagnostic CSF sampling, outpatient setting\n* Exclusion: Ventricular hemorrhage, plastic implants, infectious disease",{"count":479,"type":21},120,"Plasticizers are chemicals commonly found in many everyday items, from food packaging to medical equipment. Although they are pervasive in our daily lives, researchers still don't have a clear picture of their long-term effects on human health. Evidence suggests that these substances might disrupt various biological functions such as the immune system, the balance of gut bacteria, hormone regulation, and brain processes. While some studies have linked plasticizer exposure to health issues, definitive data from human studies are still lacking.\n\nThe PEACH study aims to bridge these knowledge gaps by investigating how plasticizers affect human health. The study focuses on understanding how these chemicals are absorbed, distributed, and accumulated in the body across different groups of patients. The investigators are particularly interested in how plasticizers influence gut microbiota and the functionality of immune cells, as well as their effects on neurotransmitters involved in brain function.\n\nA combination of patient data, systems biology, and laboratory models will be used to thoroughly assess the biological impacts of plasticizers. Advanced techniques such as mass spectrometry will aid in studying toxicokinetic properties, sequencing technologies will be used to examine immune effects, and radiouptake assays will be employed to explore interactions with neurotransmitter transport. This comprehensive methodology will provide new insights into the effects of both short-term and long-term exposure to plasticizers.\n\nThe PEACH study introduces innovative methods to the field, aiming to create a robust model for understanding how plasticizer compounds behave in the human body. It employs state-of-the-art techniques to assess the dynamics of these chemicals, marking a significant advancement in environmental health research.",[482,412,483,484,32,485],"Beta-thalassemia","Healthy Controls","Transfusion-dependent Beta-Thalassemia","Toxicity",[487,488,489,490,491,492,493,494,495],"Plasticizer","Transfusion","Systems Biology","Immunology","Microbiome","Neuropharmacology","Pharmacokinetics","Pharmacodynamics","Exposomics","2024-07-22",{"date":498,"type":45},"2024-07-24",{"date":441,"type":21},{"date":501,"type":21},"2027-09-30",{"name":376,"class":52},{"id":504,"slug":505,"hasResults":11,"nctId":506,"briefTitle":507,"officialTitle":507,"acronym":508,"eligibilityCriteria":509,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":510,"targetDuration":511,"studyType":91,"phases":4,"briefSummary":512,"conditions":513,"keywords":514,"overallStatus":137,"whyStopped":4,"lastUpdateSubmitDate":518,"lastUpdatePostDateStruct":519,"startDateStruct":521,"completionDateStruct":523,"leadSponsor":524,"locationsCount":526},"100462190","the-south-london-stroke-register-improving-the-lives-of-stroke-survivors-with-data-100462190","NCT05298436","The South London Stroke Register: Improving the Lives of Stroke Survivors With Data","SLSR","Inclusion Criteria:\n\n1. Confirmed stroke (WHO ICD-11 clinical definition)- cerebral ischaemic stroke, primary intracerebral haemorrhage, subarachnoid haemorrhage and stroke not known if ischaemic or haemorrhagic. Formerly defined Transient Ischaemic Attacks with CT\u002FMRI evidence of cerebrovascular disease are classified as stroke under this definition.\n2. Living in the study area at the time of the first stroke.\n3. First stroke since 1st January 1995 for enrolled participants. First stroke since 1st April 2022 for updated definition.\n\nExclusion Criteria:\n\n1. First ever stroke is before 1st January 1995\n2. Patients' main residence at the time of first stroke is outside the study area.\n3. Focal neurological signs resolved within 24 hours and no CT\u002FMRI scan reports evidence of cerebrovascular disease (i.e. transient ischaemic attack)\n4. CT\u002FMRI scans positive for cerebrovascular disease but absence of related focal neurological deficits (asymptomatic cerebrovascular disease)\n5. brain lesion other than stroke causes the acute symptoms such as cerebral tumour or metastases",{"count":386,"type":21},"15 Years","The South London Stroke Register (SLSR) is an observational population based registry, combining a population incidence study of stroke events in a geographically defined area of South London and a cohort study of these patients followed up over time. The SLSR has been continually ongoing since January 1995 using the WHO ICD-10 definition of stroke. From April 2022, SLSR will use the new ICD-11 definition for case identification to establish a new prospective cohort of patients identified according to the new definition.\n\nFollow up of the existing retrospective cohort of current patients will continue, providing data on long term outcomes of stroke through a program of regular patient interviews up to 15 years after stroke. Outcome measures include health outcomes, such as stroke mortality and recurrence, and measures of activities of daily living, quality of life and mental health (cognition, anxiety, depression).\n\nThe new data collection will include newly selected scales to best capture variation in key health domains and long term outcomes.\n\nThe change to ICD-11 is expected to lead to an increase in the incidence of stroke and a reduction in the average severity, but the effects of this change have not yet been measured in any population internationally. There is a need for a high quality population-based stroke incidence study to address this gap. Similarly, the factors determining the health of long-term stroke survivors can only be understood using a long running observational cohort study.\n\nThe overall purpose of this research is to continue and develop the SLSR data collection and analysis to address the needs of stroke patients in the 2020s. The current programme was funded to address the following objectives as part of a broader NIHR programme grant on using data to improve the lives of stroke survivors:\n\n* Understand the impact of the ICD-11 new definition of stroke\n* Define the outcomes and needs of long-term stroke survivors\n* Support stroke survivors and stakeholders with these detailed data and analyses\n* Describe the use of formal, informal, and social care services up to 15 years after stroke\n* Asses the influence of formal, informal, and social care use on stroke recovery and generate patient-level total costs up to 15 years after stroke",[35,182,32],[515,516,517],"Registries","Epidemiology","Cohort study","2024-03-05",{"date":520,"type":45},"2024-03-06",{"date":522,"type":45},"2022-04-01",{"date":468,"type":21},{"name":525,"class":52},"Guy's and St Thomas' NHS Foundation Trust",7,{"id":528,"slug":529,"hasResults":11,"nctId":530,"briefTitle":531,"officialTitle":532,"acronym":533,"eligibilityCriteria":534,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":535,"targetDuration":4,"studyType":22,"phases":537,"briefSummary":538,"conditions":539,"keywords":542,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":555,"lastUpdatePostDateStruct":556,"startDateStruct":558,"completionDateStruct":560,"leadSponsor":562,"locationsCount":53},"100380143","phase-3-restarting-anticoagulation-after-traumatic-intracranial-hemorrhage-100380143","NCT04229758","Restarting Anticoagulation After Traumatic Intracranial Hemorrhage","Restarting Anticoagulation After Traumatic Intracranial Hemorrhage (Restart tICrH): a Prospective Randomized Open Label Blinded Endpoint (PROBE) Pragmatic Time-dose, Response Adaptive Clinical Trial","Restart tICrH","Inclusion Criteria:\n\nEntry into the trial is primarily driven pragmatically by clinician intent to restart a Direct Oral Anticoagulant (DOAC) after anticoagulant-associated traumatic intracranial hemorrhage and equipoise concerning restart of anticoagulation at the specified time intervals. DOAC will be at label dose with label adjustments for creatinine clearance. DOAC will be at continuation dose, i.e. not initial therapy high doses in the setting of VTE.\n\n1. Acute traumatic intracranial hemorrhage on anticoagulation for Atrial Fibrillation (AF) or Venous Thromboembolism (VTE) or both (2,500 patients per year at our 40 sites)\n2. Patient is higher risk for stroke or other thrombotic events as witnessed by having a CHA2DS2-VASc score of \\> 3 (at least 3 of the following risk factors: age greater than 65,( age \\> 75 counts for two points), history of stroke or TIA, history of heart failure, history of diabetes, history of atherosclerotic vascular disease, female gender, history of hypertension) (Excludes 20% or 500 patients per year)\n\nExclusion Criteria:\n\n1. Mechanical Valve\n2. Ventricular Assist Device (VAD)\n3. SDH \\>8 mm maximum width or any midline shift at any time point or more than one SDH\n4. Physician plan to start\u002Frestart antiplatelet therapy during trial period\n5. Acute Injury Score other than head \\>=3\n6. Pregnancy\n7. Inability to understand need for adherence to study protocol\n8. Renal function below DOAC label exclusions\n9. Any active pathological bleeding (e.g. no acute blood on most recent CT)\n10. Hypersensitivity to drug or other label contraindication\n11. Any bleeding that the investigator deems unsafe to restart DOAC at 1 week post injury, or conversely unsafe to hold DOAC to 4 weeks\n12. Expected completion of DOAC therapy expected prior to 60 day primary outcome, e.g. 3-6 month VTE therapy\n13. Concomitant need for strong inducers\u002Finhibitors of p-gp and CYP3A4",{"count":536,"type":21},1100,[202],"Primary Objective:\n\nTo identify the optimal interval to restart oral anticoagulation after traumatic intracranial hemorrhage that will minimize thrombotic events and major bleeding by performing a response adaptive randomized (RAR) PROBE clinical trial of restarting in anticoagulant-associated traumatic intracranial hemorrhage patients, comparing restart at 1 week to restart at 2 weeks or at 4 weeks, with a primary composite outcome of major thrombotic events and bleeding.\n\nPrimary Outcome: 60-day composite of thromboembolic events, defined as DVT, pulmonary emboli, myocardial infarctions, ischemic strokes and systemic emboli, and bleeding events defined as non-CNS major bleeding events (modified BARC3 or above) and worsening index tICrH or new intracranial hemorrhage (ICrH).\n\nSecondary objectives of this trial include:\n\n1. To use the Trauma Quality Improvement Program (TQIP) of the American College of Surgeons - Committee on Trauma (ACS-COT), a well-established and highly respected trauma center oversight mechanism, to translate findings of the trial into practice in a closed loop.\n2. To establish a relationship between time of restarting and overall secondary events, i.e. a dose response, that favors early restarting (1 week is better than 2 weeks and 2 weeks is better than 4 weeks.\n3. To explore patient centered utility weighting of thrombotic versus bleeding composite endpoint components by: A) 60-day Disability Rating Scale (DRS) 24,25 and modified Rankin Scale (mRS)26; B) Trial patient-reported standard gamble utilities including by race, gender and ethnicity.\n4. To explore the composite without DVT in the thrombotic component",[31,32,540,541],"Bleeding","Trauma",[253,543,544,545,546,31,547,548,549,550,551,552,553,554],"Anticoagulant","Anticoagulants","Restart","Delay","ICH","SAH","SDH","DOAC","NOAC","apixaban","rivaroxaban","edoxaban","2021-05-14",{"date":557,"type":45},"2021-05-19",{"date":559,"type":21},"2021-10",{"date":561,"type":21},"2027-02",{"name":563,"class":52},"University of Texas at Austin"]