[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"complex-cardiovascular-surgery-with-cardiopulmonary-bypass\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:complex-cardiovascular-surgery-with-cardiopulmonary-bypass":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100600176","phase-3-efficacy-and-safety-of-4f-pcc-4-factor-prothrombin-complex-concentrate-in-adult-patients-undergoing-complex-cardiovascular-surgery-with-cardiopulmonary-bypass-cpb-100600176",false,"NCT07094087","Efficacy and Safety of 4F-PCC (4-Factor Prothrombin Complex Concentrate) in Adult Patients Undergoing Complex Cardiovascular Surgery With Cardiopulmonary Bypass (CPB)","A Phase 3, Multicenter, Randomized, Open-label, Controlled Study to Investigate the Efficacy and Safety of 4-Factor Prothrombin Complex Concentrate in Adult Patients Undergoing Complex Cardiovascular Surgery With Cardiopulmonary Bypass","Inclusion Criteria:\n\n* Adult greater than or equal to (≥) 18 years and has provided written informed consent.\n* Undergoing elective complex cardiovascular surgery requiring CPB, including procedures of the thoracic aorta (with or without additional cardiac interventions), aortic valve replacement + coronary artery bypass graft (CABG), complex valve surgeries, mitral valve repair + CABG, and mitral valve replacement + CABG and reoperative CABG. Reoperative procedures are permitted. Excluded surgeries are as follows: heart transplantation, insertion or removal of ventricular assist devices (except for intra-aortic balloon pumps), and acute repair of thoracoabdominal aneurysms.\n* Coagulation factor replacement (ie, 4F-PCC or FFP) is ordered in the operating room for the management of bleeding, in accordance with accepted clinical standards. The following criteria must be met:\n* INR ≥ 1.6 (point-of-care INR testing by Hemochron ≥ 5 to 10 minutes after protamine infusion for heparin reversal). If a participant needs a second dose of protamine, a new INR measurement should be performed to confirm eligibility.\n* Significant microvascular hemorrhage (ie, not due to surgical complications), as defined by a BSS score of ≥ 2.\n\nExclusion Criteria:\n\n* Administration of any systemic hemostatic therapy, such as cryoprecipitate, platelets, FFP, PCC (eg, 4-factor \u002F 3-factor PCC \\[4F-PCC \u002F 3F-PCC\\]), Factor VIII (FVIII) inhibitor bypassing activity (FEIBA), recombinant activated Factor VIIa (rFVIIa), or other coagulation factor products, in the 24 hours before study surgery, except when FFP is added to the CPB circuit.","ALL","18 Years",{"count":19,"type":20},200,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","This is a phase 3, multicenter, randomized, open-label, parallel-group, controlled study to assess the efficacy and safety of BE1116 compared with fresh frozen plasma (FFP) in adult participants undergoing complex cardiovascular surgery with CPB. The primary purpose of the study is to compare the efficacy of BE1116 and FFP in correcting coagulation factor deficiencies in bleeding participants undergoing complex cardiovascular surgery with CPB.",[26],"Complex Cardiovascular Surgery With Cardiopulmonary Bypass",[28,29,30,31,32],"Cardiopulmonary bypass","Coagulopathic Bleeding","Coagulation factor deficiency","Prothrombin complex concentrates","Fresh frozen plasma","RECRUITING","2026-05-08",{"date":36,"type":37},"2026-05-11","ACTUAL",{"date":39,"type":37},"2025-09-15",{"date":41,"type":20},"2026-12-17",{"name":43,"class":44},"CSL Behring","INDUSTRY",18,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":58,"conditions":59,"keywords":64,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":79},"100623165","jafron-cytokine-adsorber-during-pediatric-open-heart-surgeries-100623165","NCT07393087","Jafron Cytokine Adsorber During Pediatric Open-Heart Surgeries","JACKPOT","Inclusion Criteria:\n\n* Children ≤ 10 years old at study inclusion\n* Children weighing at least 5 kg at study inclusion\n* Planned for open-heart cardiac surgery with CPB-time ≥ 120 min and aortic clamping.\n* Informed consent obtained from parent(s)\u002Flegal representative\n\nExclusion Criteria:\n\n* Children having an indication to receive hemoadsorption during CPB for drugs removal or other medically justified reason\n* Previous enrolment into the current study\n* Off-pump procedure\n* Chronic immunosuppression (chronic corticosteroid therapy, chemotherapy, anti-leucocyte drugs, TNF blockers or else)\n* Known allergy to heparin or heparin induced thrombocytopenia.\n* Severe thrombopenia (platelets count before surgery \\\u003C 20G\u002FL)\n* Parent(s)\u002Flegal representative not able to understand\u002Fread French and\u002For English\n* Participation in another conflicting research study","10 Years",{"count":55,"type":20},20,[57],"NA","This prospective single-center randomized controlled trial aims at evaluating the safety and feasibility of an hemoadsorption protocol using Jafron HA-60 during cardio-pulmonary bypass in 20 pediatric patients undergoing open-heart surgery.",[60,61,26,62,63],"Cardiac Surgery Recovery","Inflammation","Cytokine Storm","Pediatric Open Heart Surgery",[65,66,67],"Feasibility pilot study","Pediatric open heart surgery","Hemoadsorption","NOT_YET_RECRUITING","2026-02-06",{"date":71,"type":37},"2026-02-10",{"date":73,"type":20},"2026-03",{"date":75,"type":20},"2029-04",{"name":77,"class":78},"Centre Hospitalier Universitaire Vaudois","OTHER",1]