NCT07032792 Factor VIII Inhibitor Bypass Activity (FEIBA) Versus Fresh Frozen Plasma As First Line Therapy For Bleeding After Cardiac Surgery
| NCT ID | NCT07032792 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Northwell Health |
| Condition | Cardiac Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2025-11-03 |
| Primary Completion | 2028-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 140 participants in total. It began in 2025-11-03 with a primary completion date of 2028-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Provision of signed and dated informed consent form * Stated willingness to comply with all study procedures and availability for the duration of the study * Male or female, aged 18 years or above * Undergoing nonemergent non-coronary cardiac surgery with the use of cardiopulmonary bypass * Patient with microvascular bleeding requiring factor transfusion as deemed by the patient care team Exclusion Criteria: * Contraindication to the administration of FEIBA or known anaphylactic or severe hypersensitivity reaction to FEIBA or any of its components * Disseminated intravascular coagulation * Acute thrombosis or embolism, including myocardial infarction * Pregnancy * Patients that are not able or do not want to consent for themselves * Patients with known coagulation disorders * Patients who received coronary artery bypass surgery * Patients who received transplants or ventricular assist devices * Patients on extracorporeal membrane oxygenator support * Patients with heparin induced thrombocytopenia * Patients who do not wish to receive blood products even when it is deemed medically necessary
Contact & Investigator
Pey-Jen Yu
PRINCIPAL INVESTIGATOR
Northwell Health
Frequently Asked Questions
Who can join the NCT07032792 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cardiac Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07032792 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07032792 currently recruiting?
Yes, NCT07032792 is actively recruiting participants. Contact the research team at kmcgowan@northwell.edu for enrollment information.
Where is the NCT07032792 trial being conducted?
This trial is being conducted at Manhasset, United States.
Who is sponsoring the NCT07032792 clinical trial?
NCT07032792 is sponsored by Northwell Health. The principal investigator is Pey-Jen Yu at Northwell Health. The trial plans to enroll 140 participants.