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Factor VIII Inhibitor Bypass Activity (FEIBA) Versus Fresh Frozen Plasma As First Line Therapy For Bleeding After Cardiac Surgery
Sponsor: Northwell Health
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
140
Start Date
2025-11-03
Completion Date
2029-11
Last Updated
2026-03-11
Healthy Volunteers
No
Conditions
Interventions
FEIBA
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.
FFP
Subjects randomized to FFP will receive up to 2 units of FFP intravenously through a preexisting central line.
Locations (1)
North Shore University Hospital
Manhasset, New York, United States