[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100595464":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":31,"locations":37,"responsibleParty":54,"collaborators":11,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":60,"acronym":11,"eligibilityCriteria":61,"healthyVolunteers":58,"sex":62,"minAge":63,"maxAge":11,"enrollmentInfo":64,"targetDuration":11,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":11,"overallStatus":40,"whyStopped":11,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"Northwell Health","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"FEIBA","EXPERIMENTAL",null,[13],"Drug: FEIBA",{"label":15,"type":16,"description":11,"interventionNames":17},"FFP","ACTIVE_COMPARATOR",[18],"Drug: FFP",[20,24],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":11},"DRUG","Subjects randomized to FEIBA will receive up to 2 vials of 500U of FEIBA through a preexisting central line at a rate that does not exceed 2 units per kg of body weight per minute for the study intervention.",[9],{"type":21,"name":15,"description":25,"armGroupLabels":26,"otherNames":11},"Subjects randomized to FFP will receive up to 2 units of FFP intravenously through a preexisting central line.",[15],[28],{"name":29,"affiliation":5,"role":30},"Pey-Jen Yu","PRINCIPAL_INVESTIGATOR",[32],{"name":33,"role":34,"phone":35,"phoneExt":11,"email":36},"Kristine McGowan","CONTACT","516-881-7035","kmcgowan@northwell.edu",[38],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"North Shore University Hospital","RECRUITING","Manhasset","New York","11030","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-73.69957,40.79788,{"lat":50,"lon":49},[53],{"name":33,"role":34,"phone":11,"phoneExt":11,"email":11},{"type":55,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100595464","phase-2-factor-viii-inhibitor-bypass-activity-feiba-versus-fresh-frozen-plasma-as-first-line-therapy-for-bleeding-after-cardiac-surgery-100595464",false,"NCT07032792","Factor VIII Inhibitor Bypass Activity (FEIBA) Versus Fresh Frozen Plasma As First Line Therapy For Bleeding After Cardiac Surgery","Inclusion Criteria:\n\n* Provision of signed and dated informed consent form\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n* Male or female, aged 18 years or above\n* Undergoing nonemergent non-coronary cardiac surgery with the use of cardiopulmonary bypass\n* Patient with microvascular bleeding requiring factor transfusion as deemed by the patient care team\n\nExclusion Criteria:\n\n* Contraindication to the administration of FEIBA or known anaphylactic or severe hypersensitivity reaction to FEIBA or any of its components\n* Disseminated intravascular coagulation\n* Acute thrombosis or embolism, including myocardial infarction\n* Pregnancy\n* Patients that are not able or do not want to consent for themselves\n* Patients with known coagulation disorders\n* Patients who received coronary artery bypass surgery\n* Patients who received transplants or ventricular assist devices\n* Patients on extracorporeal membrane oxygenator support\n* Patients with heparin induced thrombocytopenia\n* Patients who do not wish to receive blood products even when it is deemed medically necessary","ALL","18 Years",{"count":65,"type":66},140,"ESTIMATED","INTERVENTIONAL",[69],"PHASE2","Coagulopathic-induced bleeding after cardiopulmonary bypass in cardiac surgery patients is common and is associated with adverse outcomes in cardiac surgery. The hypothesis of the study is that FEIBA will be a more effective treatment than standard of care (FFP) in cardiac surgery patients who have coagulopathic-induced bleeding. This study is being conducted to determine the efficacy of FEIBA versus FFP as first line therapy in correcting coagulopathic induced microvascular bleeding in cardiac surgery patients.",[72,73,74],"Cardiac Disease","Surgery","Bleeding","2026-03-09",{"date":77,"type":78},"2026-03-11","ACTUAL",{"date":80,"type":78},"2025-11-03",{"date":82,"type":66},"2029-11",{"name":5,"class":6},1]