[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"thromboembolism\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:thromboembolism":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,45,75,114,146,179,199,222,254,277,308],{"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":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100382350","phase-4-long-term-anticoagulation-with-oral-factor-xa-inhibitor-versus-vitamin-k-antagonist-after-mechanical-aortic-valve-replacement-100382350",false,"NCT04258488","Long-term Anticoagulation With Oral Factor Xa Inhibitor Versus Vitamin K Antagonist After Mechanical Aortic Valve Replacement","Randomized, Evaluation of Long-term Anticoagulation With Oral Factor Xa Inhibitor Versus Vitamin K Antagonist After Mechanical Aortic Valve Replacement","RENOVATE","Inclusion Criteria:\n\n1. Age 19 and more\n2. At least 3 months after mechanical aortic valve replacement\n3. At least one of the conditions(as defined below) is met\n\n   * The New York Heart Association (NYHA) Functional Classification I or II; or\n   * According to the Valve Academic Research Consortium(VARC)2 criteria, confirmed proper valve function: no prosthesis-patient mismatch and mean aortic valve gradient \\\u003C20 mm Hg or peak velocity \\\u003C3 m\u002Fs, AND no moderate or severe prosthetic valve regurgitation\n4. Voluntarily participated in the written agreement\n\nExclusion Criteria:\n\n1. Old-generation mechanical valve\n2. History of mechanical valve implantation in the mitral valve, pulmonary valve, or tricuspid valve\n3. Valvular atrial fibrillation(atrial fibrillation with moderate or severe mitral stenosis)\n4. Moderate to severe mitral stenosis or regurgitation\n5. History of hemorrhagic stroke\n6. Clinically overt stroke within the last 3 months\n7. Renal failure(creatinine clearance \\\u003C15mL\u002Fmin) or on hemodialysis\n8. Left ventricular dysfunction: Left ventricular ejection fraction (LVEF) ≤40%\n9. Child-Pugh B and C hepatic impairment or any hepatic disease associated with coagulopathy\n10. Clinically significant active bleeding\n11. Bleeding or hemorrhagic disorder\n12. The increased risk of bleeding due to the following reasons\n\n    1. History of gastrointestinal ulcers or active ulcerations within the last 6 months\n    2. History of intracranial or intracerebral hemorrhage within the last 6 months\n    3. Spinal cord vascular abnormalities or intracerebral vascular abnormalities\n    4. History of the brain, spinal cord, or ophthalmic surgery within the last 6 months\n    5. History of the brain or spinal cord injury within the last 6 months\n    6. History of the brain or spinal cord injury or spinal tap, major regional anesthesia, or spinal anesthesia within the last 6 months\n    7. Esophageal varices\n    8. Arteriovenous malformation\n    9. Vascular aneurysms\n    10. Malignant tumor with a high risk of bleeding\n13. Bleeding tendencies associated with overt bleeding of\n\n    1. gastrointestinal, genitourinary, respiratory tract, or colorectal cancer\n    2. cerebrovascular hemorrhage\n    3. aneurysms- cerebral, dissecting aorta\n    4. pericarditis and pericardial effusions\n    5. bacterial endocarditis\n14. Hemodynamically unstable or pulmonary embolism required thrombolysis or embolectomy\n15. Combination therapy with other anticoagulants(Unfractionated heparin(UFH), enoxaparin, dalteparin, fondaparinux, etc.) However, the following cases are permitted\n\n    * Switching anticoagulants\n    * Intravenous UFH to keep central\u002Farterial lines open\n16. Uncontrolled moderate or severe hypertension\n17. Anemia at least one among the conditions(as defined below) is met 1) Hemoglobin level \\\u003C10.0 g\u002FdL or platelet count \\\u003C 100 x 10x9\u002FL within the last 6 months 2) Diagnosed and documented ongoing anemia\n18. Infective endocarditis\n19. Hypersensitivity to the main component or constituents of Rivaroxaban or Vitamin K antagonist\n20. Positive pregnancy test results (all pregnant women should undergo urinary human chorionic gonadotropin (hCG) testing within 7 days before screening and\u002For randomization) or during pregnancy or lactation\n21. A genetic problem with galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption\n22. The unsuitable condition of the protocol\n23. Actively participating in another drug or device investigational study, which has not completed the primary endpoint follow-up period\n24. Terminal illness with life expectancy \\\u003C12 months\n25. Vitamin K deficiency\n26. Alcoholic or psychical disorder\n27. Threatened abortion, eclampsia, or preeclampsia\n28. Concomitant use with antiplatelet in patients with a history of stroke or transient ischemic attack for the treatment of the acute coronary syndrome","ALL","19 Years",{"count":20,"type":21},1300,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","This study evaluates the long-term anticoagulation with oral factor Xa inhibitor versus vitamin K antagonist in patients receiving a mechanical aortic valve replacement.",[27,28],"AORTIC VALVE DISEASES","Thromboembolism",[30,31],"Aortic valve replacement","Mechanical valve","RECRUITING","2026-06-23",{"date":35,"type":36},"2026-06-24","ACTUAL",{"date":38,"type":36},"2022-02-21",{"date":40,"type":21},"2028-12-30",{"name":42,"class":43},"Joon Bum Kim","OTHER",16,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":57,"conditions":58,"keywords":62,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":74},"100566649","phase-2-preoperative-tranexamic-acid-txa-to-prevent-bleeding-in-patients-undergoing-major-colorectal-surgery-100566649","NCT06657924","Preoperative Tranexamic Acid (TXA) to Prevent Bleeding in Patients Undergoing Major Colorectal Surgery","Inclusion Criteria:\n\n1. Adults 18 years or older\n2. Undergoing elective or non-elective inpatient abdominal and pelvic colorectal surgery\n\nExclusion Criteria:\n\n1. Creatinine clearance less than 30 mL\u002Fminute\n2. Long-term dialysis\n3. Known defective color vision (color blind)\n4. Pregnancy\n5. History of venous or arterial thromboembolism, or active thromboembolic disease\n6. Disseminated intravascular coagulation (DIC) - clinically suspected and\u002For confirmed by platelet count on CBC, fibrinogen, INR and PTT.","18 Years","100 Years",{"count":54,"type":21},394,[56],"PHASE2","The goal of this prospective pragmatic randomized clinical trial is to determine if preoperative administration of tranexamic acid (TXA) reduces bleeding during and after major colorectal surgery. The primary questions are:\n\n* Does TXA reduce bleeding during and after surgery (change in hemoglobin from before surgery to lowest value after surgery within 30 days)\n* Does TXA reduce bleeding complications within 30 days of surgery (blood transfusion, return to the operating room or procedural intervention for bleeding, death due to bleeding)\n* Does TXA increase the risk of thromboembolic complications within 30 days of surgery (cerebrovascular accident, myocardial infarction, deep venous thrombosis, pulmonary embolism)\n\nResearchers will compare preoperative TXA to no TXA to answer the above questions.\n\nParticipants who receive TXA will receive 1 g TXA IV at the beginning and end of surgery in the operating room.",[59,60,28,61],"Bleeding","Colorectal Disorders","Tranexamic Acid",[61,63,59,64,28],"TXA","Colorectal Surgery","2026-05-27",{"date":67,"type":36},"2026-05-28",{"date":69,"type":36},"2025-02-11",{"date":71,"type":21},"2027-10-01",{"name":73,"class":43},"Kristen Ban",1,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":17,"minAge":51,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":22,"phases":85,"briefSummary":87,"conditions":88,"keywords":93,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":74},"100637597","stepwise-vs-standard-anticoagulation-for-af-patients-undergoing-cied-implantation-step-af-100637597","NCT07616414","Stepwise vs Standard Anticoagulation for AF Patients Undergoing CIED Implantation (STEP-AF)","Stepwise Versus Standard Antithrombotic Strategies in Patients With Atrial Fibrillation at High Thromboembolic Risk Undergoing CIED Procedures (STEP-AF Trial)","STEP-AF","Inclusion Criteria:\n\n1. Aged 18 years or older at the time of screening, and able to provide written informed consent;\n2. Scheduled for any CIED procedure (implantation or generator replacement), including pacemakers, implantable cardioverter-defibrillators (ICDs), and cardiac resynchronization therapy (CRT) devices;\n3. Receiving NOAC therapy for at least 5 consecutive days prior to enrollment;\n4. Diagnosed with non-valvular atrial fibrillation (and\u002For atrial flutter) with a CHA₂DS₂-VASc score ≥2, or scheduled for cardioversion or defibrillation threshold testing during the CIED procedure.\n\nExclusion Criteria:\n\n1. Presence of active systemic or local infection at the time of screening;\n2. Estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin, or any other contraindication to NOAC use;\n3. Active bleeding (e.g., gastrointestinal bleeding);\n4. Severe thrombocytopenia, defined as platelet count \\\u003C 50 × 10⁹\u002FL at screening;\n5. Life expectancy \\\u003C1 year;\n6. Pregnancy.",{"count":84,"type":21},424,[86],"NA","This is a multi-center, prospective, open-label, randomized controlled trial (STEP-AF) designed to evaluate the safety of a stepwise anticoagulation strategy compared with the guideline-recommended standard anticoagulation regimen in patients with non-valvular atrial fibrillation at high thromboembolic risk (CHA₂DS₂-VASc score ≥2) undergoing cardiac implantable electronic device (CIED) implantation. A total of 424 eligible patients will be randomized 1:1 to either the stepwise anticoagulation group (reduced-dose NOAC from 24 hours post-surgery to day 7, followed by standard-dose NOAC) or the standard anticoagulation group (standard-dose NOAC resumed 24 hours post-surgery). The primary endpoint is the incidence of clinically significant pocket hematoma within 30 days after surgery. Secondary endpoints include individual components of the primary endpoint and other composite outcomes of major perioperative bleeding events. The study aims to provide evidence-based data for optimizing perioperative anticoagulation regimens in Chinese patients undergoing CIED implantation.",[89,28,90,91,92],"Non-valvular Atrial Fibrillation (NVAF)","Cardiac Implantable Electronic Device","Perioperative Bleeding","Hematoma Postoperative",[94,90,95,96,97,98,99,100,28,91,101,102,103],"Non-valvular atrial fibrillation","CIED","Perioperative Anticoagulation","Non-Vitamin K Antagonist Oral Anticoagulant","NOAC","Stepwise Anticoagulation","Postoperative hematoma","Randomized Controlled Trial","Edoxaban","Rivaroxaban","NOT_YET_RECRUITING","2026-05-23",{"date":107,"type":36},"2026-06-01",{"date":109,"type":21},"2026-05-26",{"date":111,"type":21},"2026-12-31",{"name":113,"class":43},"Fu Wai Hospital, Beijing, China",{"id":115,"slug":116,"hasResults":11,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":120,"eligibilityCriteria":121,"healthyVolunteers":11,"sex":17,"minAge":51,"maxAge":122,"enrollmentInfo":123,"targetDuration":4,"studyType":22,"phases":125,"briefSummary":126,"conditions":127,"keywords":129,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":74},"100336383","pregnancy-and-risk-of-venous-thromboembolism-100336383","NCT03659708","Pregnancy and Risk of Venous Thromboembolism","Prospective Multicentre Randomized Clinical Trial on the Management of Pregnancies With High Risk of Venous Thrombosis","PRESCOT","Inclusion Criteria:\n\n* Adult pregnant women at high risk of VTE (with a personal history of VTE and\u002For thrombophilia)\n* At the time of inclusion, be at most in the 7th month of pregnancy\n* giving informed consent to participate to the study\n\nExclusion Criteria:\n\n* contraindication to heparin therapy,\n* women with obstetrical complications only, with no history of VTE (pre-eclampsia, HELLP\\[ Hemolysis, Elevated Liver enzymes, Low Platelet count\\],intra-uterine growth retardation, miscarriage, etc),\n* patients with a history of superficial venous thrombosis, and those with the highest VTE risk for whom clear recommendations with a high level of evidence are available (patients on long-term anticoagulants, or those with antiphospholipid syndrome or antithrombin deficiency).\n* Patient participating in an ongoing study that could interfere with the study,\n* Patient under legal protection measure.","50 Years",{"count":124,"type":21},600,[86],"The management of venous thromboembolism (VTE) risk in pregnancy still remains a challenge. An individual assessment of the VTE risk is crucial for optimal thromboprophylaxis, but there is no validated tool to help clinicians stratify the risk in pregnant women and introduce prophylactic anticoagulation at the appropriate time. Recommendations mostly based on case-control studies and expert opinions do not accurately reflect the physician's need. In view of the lack of international recommendations with a high level of evidence regarding prophylactic treatment of pregnant women at risk of thrombosis, the use of a risk stratification tool that takes all individual risk factors for VTE into consideration and which aids decisions over prophylaxis regimens may help. Investigators have previously described a VTE risk score (the Lyon-VTE-score), rating patients at increased risk of VTE and recommending individually tailored management. A retrospective evaluation of the initial score showed favorable outcomes in pregnancies with a high risk of thrombosis. A subsequent multicenter prospective study reported promising results using this score and related management strategy. The efficacy and safety after 10 years of prospective use of the Lyon-VTE-score in daily practice to guide the prescription of antithrombotic prophylaxis during pregnancy was recently evaluated and the results showed that the Lyon-VTE-score allows a standardized approach with objective criteria and can help non-specialized centers and young doctors manage these high-risk pregnancies.\n\nThe results of previous studies provide consistent conclusions on the safety and efficacy of the approach of investigators and give background for a medico-economic study to evaluate costs and consequences of this procedure. The most recent study (2005) evaluating the cost of prophylaxis in pregnant women, evaluated this cost as $1292 for each 6-week cycle of treatment. In addition, the use of such a score offers the prospect of personalized medicine, which is probably more cost-efficient compared to \"inclusive, equal treatment for all\".\n\nIn antepartum, the decision to administer thromboprophylaxis should be considered on an individual basis with regard to lowering the absolute risk of thrombosis, the inconvenience of daily subcutaneous heparin therapy and the potential risks of bleeding, heparin-induced thrombocytopenia and osteoporosis. An individual assessment of the VTE risk is crucial for optimal thromboprophylaxis, but there is no validated tool to help clinicians to stratify VTE risk in pregnant women and to introduce prophylactic anticoagulation at the right time.\n\nMost of the recommendations are grade 2C. They are mostly based on case-control studies and expert opinions and do not entirely highlight the physicians' need. The originality of this approach is the use of a risk stratification tool that takes all individual risk factors for VTE into consideration and that aids the decision-making process of antenatal anti-thrombotic prophylaxis. This study will personalize care using a score to individually assess the risk and propose appropriate prevention.\n\nThe main objective of this study is to conduct a medico-economic study to evaluate the efficiency of an innovative strategy integrating the Lyon-VTE-score in the management of pregnant patients with venous thromboembolism risk versus standard care.",[28,128],"Pregnancy",[130,131,132,133,134,135,136],"low molecular weight heparin (LMWH)","Lyon VTE-score","pregnancy","thromboprophylaxis","venous thromboembolism","quality of life","cost utility","2026-05-13",{"date":139,"type":36},"2026-05-15",{"date":141,"type":36},"2021-01-22",{"date":143,"type":21},"2031-10-22",{"name":145,"class":43},"Hospices Civils de Lyon",{"id":147,"slug":148,"hasResults":11,"nctId":149,"briefTitle":150,"officialTitle":150,"acronym":151,"eligibilityCriteria":152,"healthyVolunteers":11,"sex":17,"minAge":51,"maxAge":4,"enrollmentInfo":153,"targetDuration":4,"studyType":155,"phases":4,"briefSummary":156,"conditions":157,"keywords":164,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":74},"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":154,"type":21},464,"OBSERVATIONAL","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.",[158,159,160,161,162,163,28],"Atrial Fibrillation","Stroke Prevention in Patients With Atrial Fibrillation","Left Atrial Appendage Closure","Hemorrhage","Anticoagulants \u002F Administration & Dosage","Reduced-dose Apixaban",[165,166,167,168],"atrial fibrillation","left atrial appendage closure","anticoagulants","reduced dose apixaban","2026-05-04",{"date":171,"type":36},"2026-05-08",{"date":173,"type":21},"2026-04",{"date":175,"type":21},"2032-04",{"name":177,"class":178},"National Medical Research Center for Therapy and Preventive Medicine","OTHER_GOV",{"id":180,"slug":181,"hasResults":11,"nctId":182,"briefTitle":183,"officialTitle":183,"acronym":4,"eligibilityCriteria":184,"healthyVolunteers":11,"sex":17,"minAge":51,"maxAge":4,"enrollmentInfo":185,"targetDuration":4,"studyType":22,"phases":187,"briefSummary":188,"conditions":189,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":191,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":74},"100462414","in-vivo-detection-of-circulating-clots-in-patients-with-thromboembolism-100462414","NCT05301348","In Vivo Detection of Circulating Clots in Patients With Thromboembolism","Inclusion Criteria\n\n* Men and women, 18 years old and older.\n* Evidence of current venous or arterial thromboembolic disease diagnosed by standard of care clinical, radiographic, or laboratory testing or acute ischemic stroke.\n* Informed consent provided by the subject.\n\nExclusion Criteria\n\n* Pulmonary embolus with a need for mechanical ventilation or other ventilator support (may be on oxygen delivered by nasal cannula or mask at an FiO2 of ≤ 0.40)\n* Acute coronary syndrome (including unstable angina)\n* Significant cardiac arrhythmia (may have atrial fibrillation controlled with medication)\n* Intracardiac thrombus\n* Any embolus or thrombus requiring vascular surgery or interventional radiology to attempt acute embolectomy or thrombectomy\n* Sickle cell disease with vaso-occlusive crisis\n* Sepsis or life-threatening infection\n* Traumatic injury requiring hospitalization (within 30 days prior to enrollment)\n* Pregnancy or breastfeeding\n* Severe mental illness\n* Other conditions deemed by the investigators to put the subject at greater risk",{"count":186,"type":21},30,[86],"Subjects with thromboembolic disease or at high-risk for thromboembolic conditions diagnosed with ultrasound or other standard of care techniques will be recruited to estimate the feasibility of a device to detect in vivo CBCs.",[28],"2026-02-18",{"date":192,"type":36},"2026-02-19",{"date":194,"type":36},"2023-07-26",{"date":196,"type":21},"2027-01-31",{"name":198,"class":43},"University of Arkansas",{"id":200,"slug":201,"hasResults":11,"nctId":202,"briefTitle":203,"officialTitle":204,"acronym":205,"eligibilityCriteria":206,"healthyVolunteers":11,"sex":17,"minAge":51,"maxAge":4,"enrollmentInfo":207,"targetDuration":4,"studyType":155,"phases":4,"briefSummary":209,"conditions":210,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":221},"100351419","registry-of-thrombosis--neoplasia-of-sociedad-espaola-de-oncologa-mdica-100351419","NCT03855592","Registry of Thrombosis & NEoplasia of \"Sociedad Española de Oncología Médica\"","Observational Epidemiological Study of Cancer-associated Thrombosis: Registry of Thrombosis & NEoplasia of SEOM (TESEO Study)","TESEO","Inclusion Criteria:\n\n* Over 18 years of age with a histologically confirmed diagnosis of malignant tumor.\n* Venous or arterial thromboembolism episode, symptomatic or incidental, in the month prior or any time after the cancer diagnosis and in the three previous months to enrollment, confirmed with an imaging technique: Doppler echocardiography, computed tomography (CT) angiography, etc.\n* Signing of informed consent.\n\nExclusion Criteria:\n\n* Clinical diagnosis of thromboembolic event without radiological confirmation.\n* Presenting a single episode of superficial thrombophlebitis without association with another thromboembolic event.\n* Each patient will be recorded just once, and therefore a second thromboembolic event will be considered a rethrombosis and will be recorded as such. Patients with a rethrombosis and a previous thromboembolic event before the start of the study in each center will not be able to be included.",{"count":208,"type":21},700,"Epidemiological, observational, non-interventional, multicentric study on patients diagnosed with cancer who develop a venous or arterial thromboembolic episode, symptomatic or incidental, within a month prior to cancer diagnosis or at anytime after such diagnosis",[28,211],"Cancer","2025-05-13",{"date":214,"type":36},"2025-05-16",{"date":216,"type":36},"2018-07-04",{"date":218,"type":21},"2026-07",{"name":220,"class":43},"Fundación Sociedad Española de Oncologia Médica",48,{"id":223,"slug":224,"hasResults":11,"nctId":225,"briefTitle":226,"officialTitle":226,"acronym":4,"eligibilityCriteria":227,"healthyVolunteers":228,"sex":17,"minAge":51,"maxAge":4,"enrollmentInfo":229,"targetDuration":4,"studyType":22,"phases":230,"briefSummary":231,"conditions":232,"keywords":234,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":246,"startDateStruct":248,"completionDateStruct":250,"leadSponsor":252,"locationsCount":74},"100463355","phase-4-effect-of-tofacitinib-on-coagulation-and-platelet-function-and-its-role-in-thromboembolic-events-100463355","NCT05313620","Effect of Tofacitinib on Coagulation and Platelet Function, and Its Role in Thromboembolic Events","Inclusion Criteria:\n\nEX VIVO STUDY IN PATIENTS WITH UC\n\nPATIENTS WITH UC:\n\n* Over 18 years old.\n* Diagnosis of UC according to the criteria of the European Crohn's and Colitis Organisation (ECCO).\n* Previous treatments are allowed, provided they have remained stable for the past 3 months.\n* In the case of patients with active UC, they should have endoscopic activity within 1 month of starting the treatment (Mayo endoscopic sub-index of ≥ 2).\n* Women of childbearing age using contraceptive methods with an error rate \\\u003C1% per year. Examples of contraceptive methods whose error rate is \\\u003C1% per year are:\n\n  1. Intrauterine device (IUD).\n  2. Bilateral tubal occlusion.\n  3. Couple with vasectomy.\n  4. Sexual abstinence.\n\nINDIVIDUALS WITHOUT UC:\n\n* Over 18 years old.\n* Subjects not diagnosed with UC, or other inflammatory allergic, malignant or autoimmune diseases.\n* Women of childbearing age using contraceptive methods with an error rate \\\u003C1% per year. Examples of contraceptive methods whose error rate is \\\u003C1% per year are:\n\n  1. Intrauterine device (IUD).\n  2. Bilateral tubal occlusion.\n  3. Couple with vasectomy.\n  4. Sexual abstinence.\n\nIN VIVO STUDY IN PATIENTS WITH UC\n\nPATIENTS WITH UC:\n\n* Over 18 years old.\n* Diagnosis of UC according to the criteria of the European Crohn's and Colitis Organisation (ECCO).\n* Have indication of treatment with anti-TNFα (infliximab, adalimumab or golimumab) o tofacitinib.\n* Be the first received JAK-inhibitor or anti-TNFα with a given mechanism of action.\n* Have endoscopic activity of UC within 1 month of starting the treatment (Mayo endoscopic sub-index of ≥ 2).\n* Previous treatments (including corticosteroids and immunosuppressants) are allowed provided that they have been stable for the last 3 months before beginning treatment with JAK-inhibitor or anti-TNFα and that they are maintained at a stable dose for the duration of the study\n* Women of childbearing age using contraceptive methods with an error rate \\\u003C1% per year. Examples of contraceptive methods whose error rate is \\\u003C1% per year are:\n\n  1. Intrauterine device (IUD).\n  2. Bilateral tubal occlusion.\n  3. Couple with vasectomy.\n  4. Sexual abstinence.\n\nINDIVIDUALS WITHOUT UC:\n\n* Over 18 years old.\n* Subjects not diagnosed with UC, or other inflammatory, allergic, malignant or autoimmune diseases.\n* Women of childbearing age using contraceptive methods with an error rate \\\u003C1% per year. Examples of contraceptive methods whose error rate is \\\u003C1% per year are:\n\n  1. Intrauterine device (IUD).\n  2. Bilateral tubal occlusion.\n  3. Couple with vasectomy.\n  4. Sexual abstinence.\n\nExclusion Criteria:\n\nEX VIVO STUDY IN PATIENTS WITH UC\n\nPATIENTS WITH UC:\n\n* Under 18 years old.\n* Immune-mediated disease, neoplasm or active infection.\n* Pregnancy or lactation.\n* Alcohol or drug abuse.\n* Ostomy.\n* Abdominal surgery in the last 6 months.\n* Colectomy.\n* Active infection with hepatitis B, C or HIV virus.\n* Medical history of thromboembolic events.\n* Treatment with anticoagulants, antiplatelets or other drugs that alter the coagulation.\n* Use of combined hormonal contraceptives or hormone replacement therapy.\n* Hereditary coagulation disorders.\n* Refusal to give consent for participation in the study.\n\nINDIVIDUALS WITHOUT UC:\n\n* Under 18 years of age.\n* Advanced chronic disease or any other pathology that prevents the monitoring of the protocol of this study.\n* Pregnancy or lactation.\n* Alcohol or drug abuse.\n* Ostomy.\n* Abdominal surgery in the last 6 months.\n* Colectomy.\n* Active infection with hepatitis B, C or HIV virus.\n* Medical history of thromboembolic events.\n* Treatment with anticoagulants, antiplatelets or other drugs that alter the coagulation.\n* Use of combined hormonal contraceptives or hormone replacement therapy.\n* Hereditary coagulation disorders.\n* Refusal to give consent for participation in the study.\n\nIN VIVO STUDY IN PATIENTS WITH UC\n\nPATIENTS WITH UC:\n\n* Under 18 years old.\n* Immune-mediated disease.\n* Neoplasm or active infection.\n* Pregnancy or lactation.\n* Alcohol or drug abuse.\n* Ostomy.\n* Colectomy.\n* Active infection with hepatitis B, C or HIV virus.\n* Indication of anti-TNFα or JAK-inhibitors treatment for a cause other than UC.\n* Have previously received a drug with the same mechanism of action (anti-TNFα or JAK-inhibitors)\n* Medical history of thromboembolic events.\n* Treatment with anticoagulants, antiplatelets or other drugs that alter the coagulation.\n* Use of combined hormonal contraceptives or hormone replacement therapy.\n* Hereditary coagulation disorders.\n* Refusal to give consent for participation in the study.\n\nINDIVIDUALS WITHOUT UC:\n\n* Under 18 years of age.\n* Advanced chronic disease or any other pathology that prevents the monitoring of the protocol of this study.\n* Pregnancy or lactation.\n* Alcohol or drug abuse.\n* Active infection with hepatitis B, C or HIV virus.\n* Finding of macroscopic alterations during the colonoscopy or finding of relevant inflammatory alterations in the biopsies obtained during the colonoscopy.\n* Treatment with immunomodulators, immunosuppressants, corticosteroids or other drugs that alter the immune system.\n* Medical history of thromboembolic events.\n* Treatment with anticoagulants, antiplatelets or other drugs that alter the coagulation.\n* Use of combined hormonal contraceptives or hormone replacement therapy.\n* Hereditary coagulation disorders.\n* Refusal to give consent for participation in the study.\n* Abdominal surgery in the last 6 months.",true,{"count":186,"type":21},[24],"Post-authorization, prospective and unicenter clinical trial, in which patients with UC will be included. The treatment with anti-TNFα (infliximab, adalimumab or golimumab) or JAK-inhibitors (tofacitinib) will be initiated by clinical practice and the choice will be made at the discretion of the investigator at the center where the patients will be recruited (Hospital Universitario de La Princesa). In the case of the group of patients treated with tofacitinib, the selection will be made following the action protocol implemented in our center, in which this drug is usually reserved for those cases refractory to anti-TNFα and\u002For vedolizumab. There will be no random assignment of treatment. The drugs will be used in the approved indications and conditions of use.",[233,28],"Ulcerative Colitis",[235,236,237,238,239,240,241,242,243,244],"ulcerative colitis","Tromboembolism","Coagulation","Platelet Function","Tofacitinib","JAK inhibitors","anti-TNF","Infliximab","Adalimumab","Golimumab","2025-03-12",{"date":247,"type":36},"2025-03-17",{"date":249,"type":36},"2022-04-01",{"date":251,"type":21},"2025-12",{"name":253,"class":43},"Fundación de Investigación Biomédica - Hospital Universitario de La Princesa",{"id":255,"slug":256,"hasResults":11,"nctId":257,"briefTitle":258,"officialTitle":258,"acronym":4,"eligibilityCriteria":259,"healthyVolunteers":11,"sex":17,"minAge":51,"maxAge":4,"enrollmentInfo":260,"targetDuration":4,"studyType":155,"phases":4,"briefSummary":262,"conditions":263,"keywords":265,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":269,"startDateStruct":271,"completionDateStruct":273,"leadSponsor":275,"locationsCount":74},"100578072","the-frequency-of-peripheral-arterial-disease-in-patients-with-deep-vein-thrombosis-of-the-lower-limbs-100578072","NCT06806540","The Frequency of Peripheral Arterial Disease in Patients with Deep Vein Thrombosis of the Lower Limbs","Inclusion Criteria:\n\n* Age \\> 18 years\n* Diagnosis of unprovoked, provoked, or cancer-related DVT\n* Diagnosis of DVT in the lower limbs, both proximal and distal, subjected to compression ultrasound within 6 months of diagnosis\n* Ability to provide informed consent\n\nExclusion Criteria:\n\n* Diagnosis of upper limb DVT or DVT in other locations, if not concurrent with lower limb DVT\n* Diagnosis of superficial venous thrombosis (SVT), if not concurrent with lower limb DVT\n* Diagnosis of DVT associated with central venous catheters (CVC)\n* Presence of epithelial or basal cell carcinomas, as they are associated with a low risk of deep vein thrombosis",{"count":261,"type":21},440,"The aim of the study is to assess the frequency of Peripheral Arterial Disease (PAD) and cardiovascular risk factors in patients with unprovoked Deep Vein Thrombosis (DVT) of the lower limbs, comparing them with patients who have provoked DVT or cancer-related DVT. Additionally, the study aims to examine the association between the Ankle-Brachial Index (ABI) and Carotid Intima-Media Thickness (IMT) in the different patient groups.\n\nThis is an observational, spontaneous, monocentric, non-pharmacological study conducted on outpatient, non-hospitalized patients diagnosed with lower limb DVT, including both unprovoked and provoked DVT, as well as cancer-related DVT. The patients are followed at the Vascular Day Service of the SSD U.O. Angiology and Coagulation Disorders Unit at the Sant'Orsola Malpighi Polyclinic in Bologna. The study has a retrospective design for patients with DVT diagnosed between October 1, 2020, and the date of project approval, and a prospective design for patients diagnosed with DVT after this date. The study is expected to conclude by December 31, 2027.",[28,264],"Peripheral Arterial Disease",[266,267],"TVP","AOP","2025-01-28",{"date":270,"type":36},"2025-02-04",{"date":272,"type":36},"2021-06-10",{"date":274,"type":21},"2027-12-31",{"name":276,"class":43},"IRCCS Azienda Ospedaliero-Universitaria di Bologna",{"id":278,"slug":279,"hasResults":11,"nctId":280,"briefTitle":281,"officialTitle":282,"acronym":283,"eligibilityCriteria":284,"healthyVolunteers":11,"sex":17,"minAge":51,"maxAge":4,"enrollmentInfo":285,"targetDuration":4,"studyType":22,"phases":287,"briefSummary":288,"conditions":289,"keywords":292,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":299,"lastUpdatePostDateStruct":300,"startDateStruct":302,"completionDateStruct":304,"leadSponsor":306,"locationsCount":74},"100550069","phase-4-comparing-anticoagulation-strategies-using-ufh-argatroban-and-lmwh-for-ecmo-support-100550069","NCT06442267","Comparing Anticoagulation Strategies Using UFH, Argatroban and LMWH for ECMO Support","A Three-arm Randomized Controlled Non-inferiority Pilot Study Comparing Anticoagulation Strategies Using Unfractionated Heparin, Argatroban and Low-molecular-weight Heparin for Extracorporeal Membrane Oxygenation Support","CASUAL-ECMO","Inclusion Criteria:\n\n* either\n\n  * require ECMO support or\n  * have been started on ECMO therapy within the last 12 hours\n\nExclusion Criteria:\n\n* Patients exhibiting contraindications to anticoagulation in general or any of the three investigated substances\n* Patients who are pregnant\n* Patients suffering from a clinically relevant pre-existing coagulopathy\n* Patients, for whom screening, randomization and implementation of study protocol cannot be initiated within 12 hours after cannulation\n* Patients receiving ongoing therapeutic systemic anticoagulation prior to ECMO implantation, or exhibiting an indication for therapeutic anticoagulation (e.g., pulmonary embolism)\n* Patients whose total duration of ECMO support lasts less than 24 hours\n* Patients with start of ECMO support during CPR (eCPR)\n* Patients with passive decarboxylation, without an active pumping system\n* Patients, who have been weaned off ECMO support within the last 30 days\n* Patients with central ECMO cannulation and\u002For after cardiopulmonary bypass",{"count":286,"type":21},90,[24],"A three-arm randomized controlled non-inferiority pilot study comparing anticoagulation strategies using unfractionated heparin, argatroban and enoxaparin for extracorporeal membrane oxygenation support conducted as an investigator-initiated, prospective, parallel group, open-label, active comparator controlled, single center, phase IV study to evaluate the non-inferiority of enoxaparin or argatroban for anticoagulation during ECMO therapy in comparison to the current standard, unfractionated heparin, as measured by the incidence of thromboembolic events during the duration of ECMO therapy",[290,291,28,59],"Respiratory Insufficiency","Circulatory Failure",[293,294,295,59,296,297,298],"ECMO","Anticoagulation","Thromboembolic Event","extracorporeal life support","anticoagulant","heparin","2024-10-26",{"date":301,"type":36},"2024-10-29",{"date":303,"type":36},"2024-07-30",{"date":305,"type":21},"2027-07-30",{"name":307,"class":43},"Medical University of Vienna",{"id":309,"slug":310,"hasResults":11,"nctId":311,"briefTitle":312,"officialTitle":312,"acronym":4,"eligibilityCriteria":313,"healthyVolunteers":11,"sex":17,"minAge":51,"maxAge":4,"enrollmentInfo":314,"targetDuration":316,"studyType":155,"phases":4,"briefSummary":317,"conditions":318,"keywords":320,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":331,"lastUpdatePostDateStruct":332,"startDateStruct":334,"completionDateStruct":336,"leadSponsor":338,"locationsCount":74},"100410712","laac-registry-clinical-outcome-after-echocardiography-guided-laa-closure-100410712","NCT04628078","LAAC-registry: Clinical Outcome After Echocardiography-guided LAA-closure","Inclusion Criteria:\n\n* Age\\> 18\n* Written informed consent to participate in the study\n* Patients with paroxysmal, persistent, or permanent non-valvular AF and CHA2DS2-VASc Score of ≥2 that are planned for an elective LAA-closure\n* Anatomic characteristics allow placement of a CE marked device, dedicated for LAAC\n\nExclusion Criteria:\n\n* None. Considering the nature of the project, which is to prospectively collect information on all patients treated with LAAC in our center, we will only exclude patients unwilling to sign the informed consent.",{"count":315,"type":21},1000,"5 Years","The study aims at comparing, in a large cohort of consecutive clinically indicated left atrial appendage closure, clinical and imaging outcomes between different subpopulations.",[158,319,28],"Cardiovascular Diseases",[321,322,323,324,325,326,327,328,329,330],"Left atrial appendage closure","Amulet","Watchman","Watchman flx","Acp","Cardiac computed tomography angiography","Transesophageal echocardiography","Peridevice leak","Thromboembolic events","Atrial fibrillation","2023-02-21",{"date":333,"type":36},"2023-02-22",{"date":335,"type":36},"2015-08-12",{"date":337,"type":21},"2027-06-01",{"name":339,"class":43},"Insel Gruppe AG, University Hospital Bern"]