Cardiovascular Disease Clinical Trial
Official title:
Factor VIII Inhibitor Bypass Activity (FEIBA) for the Reduction of Transfusion in Cardiac Surgery: A Randomized Double Blind Placebo Controlled Pilot Trial
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.
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.
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