Factor VIII Inhibitor Bypass Activity (FEIBA) Versus Fresh Frozen Plasma As First Line Therapy For Bleeding After Cardiac Surgery
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 intrav…
Interventions
- DrugFEIBA
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.
- DrugFFP
Subjects randomized to FFP will receive up to 2 units of FFP intravenously through a preexisting central line.
Location
- North Shore University HospitalManhasset, New York