FEIBA and Use of Blood Products in Cardiac Surgery
Status and phase
Conditions
Treatments
Details and patient eligibility
About
The purpose of this pilot study is to evaluate the feasibility of the prophylactic administration of Factor VIII Inhibitor Bypass Activity (FEIBA) at termination of cardiopulmonary bypass (CPB) period. Specifically, the proposed study is designed to demonstrate the potential role of FEIBA administration in reducing the need for allogeneic transfusion to treat refractory coagulopathy in high risk patients.
Full description
Factor eight inhibitor bypassing activity (FEIBA) is currently approved for use in this country for the treatment of patients with Hemophilia and inhibitors at a dose of 50-100 units/kg. There is a large body of evidence demonstrating the safety and efficacy of FEIBA for Hemophilia patients with inhibitor and has a theoretical advantage compared to current blood product transfusion methods, as it replenishes multiple depleted factors that are lost with prolonged exposure to CPB.
This pilot study is a single center, randomized, double-blinded, placebo controlled trial assessing the feasibility and safety of factor eight inhibitor bypass activity (FEIBA) in patients undergoing major cardiovascular surgery requiring prolonged CPB. The study population will consist of adult patients undergoing elective cardiac surgery at OHSU. Twelve participants will randomly assigned to receive FEIBA or placebo during their surgical procedure.
Patients will be followed to review for adverse events while in the ICU, and up to four weeks after discharge.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Age 18 or older
- Elective aortic or aortic valve procedures, coronary re-implantation (Bentall) with cardiopulmonary bypass, and/or deep hypothermic circulatory arrest.
- Written informed consent
Exclusion criteria
- Contraindications to the administration of FIEBA or known anaphylactic or severe hypersensitivity reactions to FEIBA or any of its components
- Disseminated intravascular coagulation (DIC)
- Acute thrombosis or embolism, including myocardial infarction
- Pregnant women
- Decisionally impaired adults
- Prisoners
- Expressed unwillingness or are otherwise deemed unable to provide written informed consent.
Trial design
Primary purpose
Allocation
Interventional model
Masking
12 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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