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

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

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.

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