[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100600176":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":34,"locations":40,"responsibleParty":224,"collaborators":11,"id":226,"slug":227,"hasResults":228,"nctId":229,"briefTitle":230,"officialTitle":231,"acronym":11,"eligibilityCriteria":232,"healthyVolunteers":228,"sex":233,"minAge":234,"maxAge":11,"enrollmentInfo":235,"targetDuration":11,"studyType":238,"phases":239,"briefSummary":241,"conditions":242,"keywords":244,"overallStatus":43,"whyStopped":11,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":250,"startDateStruct":253,"completionDateStruct":255,"leadSponsor":257,"locationsCount":258},{"fullName":5,"class":6},"CSL Behring","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"BE1116","EXPERIMENTAL",null,[13],"Biological: BE1116",{"label":15,"type":16,"description":11,"interventionNames":17},"Fresh frozen plasma","ACTIVE_COMPARATOR",[18],"Biological: FFP",[20,26],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"BIOLOGICAL","A single dose of BE1116 will be administered by intravenous (IV) infusion intraoperatively.",[9],[25],"4F-PCC",{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":11},"FFP","A single dose of FFP will be administered as investigational product (IP) by IV infusion intraoperatively.",[15],[31],{"name":32,"affiliation":5,"role":33},"Study Director","STUDY_DIRECTOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":11,"email":39},"Trial Registration Coordinator","CONTACT","+1 610-878-4697","clinicaltrials@cslbehring.com",[41,55,66,76,86,96,106,116,126,136,146,158,167,176,186,197,207,212],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":11},"UCLA Health - Ronald Reagan Medical Center","RECRUITING","Los Angeles","California","90095","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-118.24368,34.05223,{"lat":53,"lon":52},{"facility":56,"status":57,"city":58,"state":59,"zip":60,"country":47,"countryCode":48,"cosmosGeoPoint":61,"geoPoint":65,"contacts":11},"University of Chicago Medicine","NOT_YET_RECRUITING","Chicago","Illinois","60637",{"type":50,"coordinates":62},[63,64],-87.65005,41.85003,{"lat":64,"lon":63},{"facility":67,"status":43,"city":68,"state":69,"zip":70,"country":47,"countryCode":48,"cosmosGeoPoint":71,"geoPoint":75,"contacts":11},"University of Maryland Medical Center (UMMC)","Baltimore","Maryland","21201",{"type":50,"coordinates":72},[73,74],-76.61219,39.29038,{"lat":74,"lon":73},{"facility":77,"status":57,"city":78,"state":79,"zip":80,"country":47,"countryCode":48,"cosmosGeoPoint":81,"geoPoint":85,"contacts":11},"North Shore University Hospital","Manhasset","New York","11040",{"type":50,"coordinates":82},[83,84],-73.69957,40.79788,{"lat":84,"lon":83},{"facility":87,"status":43,"city":88,"state":89,"zip":90,"country":47,"countryCode":48,"cosmosGeoPoint":91,"geoPoint":95,"contacts":11},"University of Cincinnati","Cincinnati","Ohio","45267",{"type":50,"coordinates":92},[93,94],-84.51439,39.12711,{"lat":94,"lon":93},{"facility":97,"status":43,"city":98,"state":99,"zip":100,"country":47,"countryCode":48,"cosmosGeoPoint":101,"geoPoint":105,"contacts":11},"OUHSC (University of Oklahoma Health Sciences Center)","Oklahoma City","Oklahoma","73104",{"type":50,"coordinates":102},[103,104],-97.51643,35.46756,{"lat":104,"lon":103},{"facility":107,"status":43,"city":108,"state":109,"zip":110,"country":47,"countryCode":48,"cosmosGeoPoint":111,"geoPoint":115,"contacts":11},"Oregon Health & Sciences University","Portland","Oregon","97239",{"type":50,"coordinates":112},[113,114],-122.67621,45.52345,{"lat":114,"lon":113},{"facility":117,"status":43,"city":118,"state":119,"zip":120,"country":47,"countryCode":48,"cosmosGeoPoint":121,"geoPoint":125,"contacts":11},"Thomas Jefferson University Hospital","Philadelphia","Pennsylvania","19107",{"type":50,"coordinates":122},[123,124],-75.16362,39.95238,{"lat":124,"lon":123},{"facility":127,"status":57,"city":128,"state":129,"zip":130,"country":47,"countryCode":48,"cosmosGeoPoint":131,"geoPoint":135,"contacts":11},"UT Southwestern Medical Center","Dallas","Texas","75390",{"type":50,"coordinates":132},[133,134],-96.80667,32.78306,{"lat":134,"lon":133},{"facility":137,"status":57,"city":138,"state":139,"zip":140,"country":47,"countryCode":48,"cosmosGeoPoint":141,"geoPoint":145,"contacts":11},"University of Virginia Health System","Charlottesville","Virginia","22908",{"type":50,"coordinates":142},[143,144],-78.47668,38.02931,{"lat":144,"lon":143},{"facility":147,"status":57,"city":148,"state":149,"zip":150,"country":151,"countryCode":152,"cosmosGeoPoint":153,"geoPoint":157,"contacts":11},"Kingston Health Science Center","Kingston","Ontario","K7L 2V7","Canada","CA",{"type":50,"coordinates":154},[155,156],-76.48098,44.22976,{"lat":156,"lon":155},{"facility":159,"status":43,"city":160,"state":149,"zip":161,"country":151,"countryCode":152,"cosmosGeoPoint":162,"geoPoint":166,"contacts":11},"London Health Sciences Center - University Campus","London","N6A 5A5",{"type":50,"coordinates":163},[164,165],-81.23304,42.98339,{"lat":165,"lon":164},{"facility":168,"status":57,"city":169,"state":149,"zip":170,"country":151,"countryCode":152,"cosmosGeoPoint":171,"geoPoint":175,"contacts":11},"University of Toronto - St. Michael's Hospital (SMH) - Keenan Research Centre for Biomedical Science","Toronto","M5B 1W8",{"type":50,"coordinates":172},[173,174],-79.39864,43.70643,{"lat":174,"lon":173},{"facility":177,"status":57,"city":178,"state":179,"zip":180,"country":151,"countryCode":152,"cosmosGeoPoint":181,"geoPoint":185,"contacts":11},"Universite de Montreal-Institut de Cardiologie de Montreal (ICM) Montreal Heart Institute (MHI)","Montreal","Quebec","H1T1C8",{"type":50,"coordinates":182},[183,184],-73.58781,45.50884,{"lat":184,"lon":183},{"facility":187,"status":43,"city":188,"state":188,"zip":189,"country":190,"countryCode":191,"cosmosGeoPoint":192,"geoPoint":196,"contacts":11},"Kyushu University Hospital","Fukuoka","812-8582","Japan","JP",{"type":50,"coordinates":193},[194,195],130.41667,33.6,{"lat":195,"lon":194},{"facility":198,"status":57,"city":199,"state":200,"zip":201,"country":190,"countryCode":191,"cosmosGeoPoint":202,"geoPoint":206,"contacts":11},"National Cerebral and Cardiovascular Center","Suita","Osaka","564-8565",{"type":50,"coordinates":203},[204,205],135.51567,34.76143,{"lat":205,"lon":204},{"facility":208,"status":57,"city":209,"state":210,"zip":211,"country":190,"countryCode":191,"cosmosGeoPoint":11,"geoPoint":11,"contacts":11},"Sakakibara Heart Institute","Fuchu-shi","Tokyo","183-0003",{"facility":213,"status":57,"city":214,"state":215,"zip":216,"country":217,"countryCode":218,"cosmosGeoPoint":219,"geoPoint":223,"contacts":11},"Hospital Civil de Guadalajara","Guadalajara","Jalisco","44100","Mexico","MX",{"type":50,"coordinates":220},[221,222],-103.34749,20.67738,{"lat":222,"lon":221},{"type":225,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","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":236,"type":237},200,"ESTIMATED","INTERVENTIONAL",[240],"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.",[243],"Complex Cardiovascular Surgery With Cardiopulmonary Bypass",[245,246,247,248,15],"Cardiopulmonary bypass","Coagulopathic Bleeding","Coagulation factor deficiency","Prothrombin complex concentrates","2026-05-08",{"date":251,"type":252},"2026-05-11","ACTUAL",{"date":254,"type":252},"2025-09-15",{"date":256,"type":237},"2026-12-17",{"name":5,"class":6},18]