drugset / Trial / NCT07032792

Factor VIII Inhibitor Bypass Activity (FEIBA) Versus Fresh Frozen Plasma As First Line Therapy For Bleeding After Cardiac Surgery

NCT07032792 ↗

Phase 2 Recruiting 140 enrolled Northwell Health
RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2025-11-03
Primary completion
2028-11
Completion
2029-11

Drugs

EvaluationDrugModalityDoseRoute
Comparator FFP Unknown — Intravenous
Subject Factor VIII Inhibitor Bypass Activity Unknown 500 iu Intravenous