[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100582862":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":15,"locations":24,"responsibleParty":48,"collaborators":10,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":53,"sex":59,"minAge":60,"maxAge":10,"enrollmentInfo":61,"targetDuration":10,"studyType":64,"phases":10,"briefSummary":65,"conditions":66,"keywords":70,"overallStatus":27,"whyStopped":10,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"University Hospital, Motol","OTHER",[8,12],{"label":9,"type":10,"description":11,"interventionNames":10},"UFH Anticoagulation Group",null,"Participants in this group will receive unfractionated heparin (UFH) as the standard anticoagulation regimen during perioperative veno-arterial (V-A) ECMO support for bilateral lung transplantation.\n\nUFH Administration:\n\nA bolus of 20-40 IU\u002Fkg UFH will be administered 30 minutes before ECMO initiation.\n\nContinuous UFH infusion of 2-6 mL\u002Fh (dilution: 100 mg\u002F50 mL) will be maintained.\n\nCoagulation Monitoring:\n\nROTEM (EXTEM, INTEM, HEPTEM, FIBTEM) will be used for real-time assessment. The target CT INTEM\u002FCT HEPTEM ratio will be maintained at 1.2-1.5 to guide anticoagulation adjustments.\n\nCoagulation and Hemostasis Assessments:\n\nStandard laboratory coagulation tests (aPTT, PT, TT, fibrinogen, FXIII, D-dimers, anti-Xa, platelet count, hemoglobin, hematocrit) will be performed at predefined timepoints.\n\nPoint-of-care (POC) testing and thrombin generation test (TGT) will be used for additional evaluation.",{"label":13,"type":10,"description":14,"interventionNames":10},"LMWH Anticoagulation Group","Participants in this group will receive low-molecular-weight heparin (LMWH) as an alternative anticoagulation strategy during perioperative veno-arterial (V-A) ECMO support for bilateral lung transplantation.\n\nLMWH Administration:\n\nA bolus of 20-40 IU\u002Fkg LMWH (Enoxaparin) will be administered 30 minutes before ECMO initiation.\n\nContinuous LMWH infusion of 2-6 mL\u002Fh (dilution: 100 mg\u002F50 mL) will be maintained.\n\nCoagulation Monitoring:\n\nROTEM (EXTEM, INTEM, HEPTEM, FIBTEM) will be used for real-time assessment. The CT INTEM\u002FCT HEPTEM difference will be maintained at 20-30 seconds to guide anticoagulation adjustments.\n\nCoagulation and Hemostasis Assessments:\n\nStandard laboratory coagulation tests (aPTT, PT, TT, fibrinogen, FXIII, D-dimers, anti-Xa, platelet count, hemoglobin, hematocrit) will be performed at predefined timepoints.\n\nPoint-of-care (POC) testing and thrombin generation test (TGT) will be used for additional evaluation.",[16,21],{"name":17,"role":18,"phone":19,"phoneExt":10,"email":20},"Miroslav Durila, prof. M.D., Ph.D., MHA","CONTACT","+420224435440","miroslav.durila@fnmoto.cz",{"name":22,"role":18,"phone":19,"phoneExt":10,"email":23},"Gabriela Holubova, M.D.","gabriela.holubova@fnmotol.cz",[25],{"facility":26,"status":27,"city":28,"state":29,"zip":30,"country":31,"countryCode":10,"cosmosGeoPoint":32,"geoPoint":37,"contacts":38},"University Hospital Motol, 2nd Faculty of Medicine, Charles University in Prague and 3rd Department of Surgery, First Faculty of Medicine, Charles University, and Motol University Hospital, Lung Transplant Program","RECRUITING","Prague","Czech Republic","150 06","Czechia",{"type":33,"coordinates":34},"Point",[35,36],14.42076,50.08804,{"lat":36,"lon":35},[39,41,42,44,47],{"name":17,"role":18,"phone":19,"phoneExt":10,"email":40},"miroslav.durila@fnmotol.cz",{"name":22,"role":18,"phone":19,"phoneExt":10,"email":23},{"name":17,"role":43,"phone":10,"phoneExt":10,"email":10},"PRINCIPAL_INVESTIGATOR",{"name":45,"role":46,"phone":10,"phoneExt":10,"email":10},"Kristyna Petrovicova, M.D.","SUB_INVESTIGATOR",{"name":22,"role":46,"phone":10,"phoneExt":10,"email":10},{"type":43,"investigatorFullName":49,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Durila Miroslav MUDr. Ph.D.","Prof. M.D. Miroslav Durila, Ph.D., MHA","100582862","prospective-observational-pilot-study-of-lmwh-versus-ufh-as-ecmo-anticoagulation-in-lung-transplantation-100582862",false,"NCT06868823","Prospective Observational Pilot Study of LMWH Versus UFH as ECMO Anticoagulation in Lung Transplantation","LMWH Versus UFH as ECMO Anticoagulation in Lung Transplantation: A Prospective, Observational, and Pilot Study","LUX-ET-LT","Inclusion Criteria:\n\n1. ⃣ Adults (≥18 years old).\n2. ⃣ Patients undergoing bilateral lung transplantation with perioperative veno-arterial (V-A) ECMO support.\n3. ⃣ Planned perioperative anticoagulation with either UFH or LMWH, as determined by the attending anesthesiologist.\n4. ⃣ Ability to provide informed consent or consent provided by a legally authorized representative.\n\nExclusion Criteria:\n\n1. ⃣ Patients receiving ECMO as a bridge to lung transplantation.\n2. ⃣ Patients requiring postoperative continuation of ECMO.\n3. ⃣ Patients with perioperative blood loss ≥3,000 mL.\n4. ⃣ Patients undergoing lung re-transplantation.\n5. ⃣ History of severe coagulopathy or bleeding disorder.\n6. ⃣ Active use of antiplatelet or anticoagulant therapy (excluding study anticoagulants).\n7. ⃣ Known heparin-induced thrombocytopenia (HIT).\n8. ⃣ Severe liver dysfunction (Child-Pugh C) or end-stage renal disease requiring dialysis.\n9. ⃣ Pregnant or breastfeeding women.","ALL","18 Years",{"count":62,"type":63},40,"ESTIMATED","OBSERVATIONAL","The aim of this observational pilot study is to evaluate the effectiveness and safety of low-molecular-weight heparin (LMWH) compared to unfractionated heparin (UFH) as anticoagulation in perioperative ECMO during bilateral lung transplantation.\n\nThe main question this study seeks to answer is:\n\nDoes LMWH provide a safe and effective alternative to UFH for ECMO anticoagulation in lung transplantation, with reduced bleeding and thrombotic complications?\n\nPatients undergoing bilateral lung transplantation with perioperative veno-arterial (V-A) ECMO support will be assigned to one of two anticoagulation strategies:\n\nUFH group: Standard UFH anticoagulation monitored using ROTEM. LMWH group: Enoxaparin-based anticoagulation monitored using ROTEM. The study will assess perioperative blood loss, hemoglobin levels, transfusion needs, and thrombotic events. Additional analyses will include coagulation profile assessments using point-of-care (POC) tests, thrombin generation test (TGT), and laboratory coagulation parameters.",[67,68,69],"Lung Transplantation","Extracorporeal Membrane Oxygenation (ECMO)","Anticoagulants and Bleeding Disorders",[67,68,71,72,73,74,75,76,77,78],"Anticoagulation","Low-Molecular-Weight Heparin (LMWH)","Unfractionated Heparin (UFH)","Thrombosis Prevention","Bleeding Complications","Coagulation Management in Surgery","Hemorrhagic and Thrombotic Events","Perioperative Hemostasis","2025-06-09",{"date":81,"type":82},"2025-06-10","ACTUAL",{"date":84,"type":82},"2025-05-01",{"date":86,"type":63},"2025-12-31",{"name":5,"class":6},1]