Ignite Creation Date:
2025-12-24 @ 3:15 PM
Ignite Modification Date:
2025-12-25 @ 1:37 PM
Study NCT ID:
NCT07032792
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-24
First Post:
2025-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Factor VIII Inhibitor Bypass Activity (FEIBA) Versus Fresh Frozen Plasma As First Line Therapy For Bleeding After Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}], 'ancestors': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C065655', 'term': 'anti-inhibitor coagulant complex'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2029-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-18', 'studyFirstSubmitDate': '2025-04-21', 'studyFirstSubmitQcDate': '2025-06-18', 'lastUpdatePostDateStruct': {'date': '2025-06-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total post-treatment pRBC transfusion within 24 hours of surgery', 'timeFrame': '24 hours'}], 'secondaryOutcomes': [{'measure': 'Total pRBC transfusion after administration of study drug', 'timeFrame': 'From time of administration of study drug until time of discharge or up to 3 months, whichever comes first.'}, {'measure': 'Total units of posttreatment platelet transfusion within 24 hours of surgery', 'timeFrame': '24 hours'}, {'measure': 'Total units of posttreatment cryoprecipitate transfusion within 24 hours of surgery', 'timeFrame': '24 hours'}, {'measure': 'Total units of FEIBA given within 24 hours of surgery', 'timeFrame': '24 hours'}, {'measure': 'Total units of Fresh Frozen Plasma (FFP) given within 24 hours of surgery', 'timeFrame': '24 hours'}, {'measure': 'Total mLs of chest tube output within 12 hours of surgery', 'timeFrame': '12 hours', 'description': 'This is being assessed as chest tube output may be an indicator of ongoing bleeding'}, {'measure': 'Incidence of adverse postoperative events', 'timeFrame': 'Perioperative', 'description': 'This can include thrombotic events, acute kidney injury, reoperation for bleeding, prolonged intubation, atrial fibrillation, anaphylaxis.'}, {'measure': 'Length of intubation', 'timeFrame': 'Perioperative'}, {'measure': 'Length of hospital stay', 'timeFrame': 'From date of hospital admission until date of discharge or up to 3 months, whichever comes first.'}, {'measure': '30-day mortality', 'timeFrame': '30 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiac Disease', 'Surgery', 'Bleeding']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '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'}, 'identificationModule': {'nctId': 'NCT07032792', 'briefTitle': 'Factor VIII Inhibitor Bypass Activity (FEIBA) Versus Fresh Frozen Plasma As First Line Therapy For Bleeding After Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Northwell Health'}, 'officialTitle': 'Factor VIII Inhibitor Bypass Activity (FEIBA) Versus Fresh Frozen Plasma As First Line Therapy For Bleeding After Cardiac Surgery', 'orgStudyIdInfo': {'id': '24-0293'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FEIBA', 'interventionNames': ['Drug: FEIBA']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'FFP', 'interventionNames': ['Drug: FFP']}], 'interventions': [{'name': 'FEIBA', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['FEIBA']}, {'name': 'FFP', 'type': 'DRUG', 'description': 'Subjects randomized to FFP will receive up to 2 units of FFP intravenously through a preexisting central line.', 'armGroupLabels': ['FFP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11030', 'city': 'Manhasset', 'state': 'New York', 'country': 'United States', 'contacts': [{'name': 'Kristine McGowan', 'role': 'CONTACT'}], 'facility': 'North Shore University Hospital', 'geoPoint': {'lat': 40.79788, 'lon': -73.69957}}], 'centralContacts': [{'name': 'Kristine McGowan', 'role': 'CONTACT', 'email': 'kmcgowan@northwell.edu', 'phone': '516-881-7035'}], 'overallOfficials': [{'name': 'Pey-Jen Yu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwell Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwell Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}