drugset / Trial / NCT07032792
Factor VIII Inhibitor Bypass Activity (FEIBA) Versus Fresh Frozen Plasma As First Line Therapy For Bleeding After Cardiac Surgery
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | FFP | Unknown | — | Intravenous |
| Subject | Factor VIII Inhibitor Bypass Activity | Unknown | 500 iu | Intravenous |