Factor VIII Inhibitor Bypass Activity (FEIBA) for the Reduction of Transfusion in Cardiac Surgery: A Randomized, Double-Blind, Placebo-Controlled, Pilot Trial

Abstract

Background Uncontrolled bleeding after cardiac surgery can be life threatening. Factor eight inhibitor bypassing activity (FEIBA) is a prothrombin complex concentrate empirically used as rescue therapy for correction of refractory bleeding diathesis post cardiopulmonary bypass (CPB). FEIBA use as rescue therapy for bleeding diathesis after CPB has been associated with a low incidence of complications and a reduction in transfusion requirement and re-exploration. The feasibility and efficacy of early administration of FEIBA after termination of CPB have not been studied.Methods We designed a small randomized, double-blinded, placebo-controlled pilot trial to determine the feasibility of a larger trial testing the hypothesis that FEIBA decreases transfusion requirements after CPB. Twelve adult patients undergoing elective major aortic cardiovascular surgery at a tertiary referral hospital were equally randomized to receive a single dose of either FEIBA or matched placebo intraoperatively at the end of CPB. The study was designed to evaluate the feasibility of a larger pivotal trial to determine the effectiveness of FEIBA in reducing the total volume of blood products transfused perioperatively, and its safety profile.Results There were no protocol deviations or events of unblinding, and adverse events were not different between groups. Patients in the FEIBA group were older, more likely to be female, had higher BMI, lower hematocrit, and longer hypothermic circulatory arrest. There were no differences in post randomization blood product transfusions (difference FEIBA vs. placebo: -899 mL; 95%CI: -5,206 to 3,409, p = 0.65).Conclusions This pilot trial confirmed the adequacy of the trial design that involved the early, blinded administration of FEIBA, by demonstrating excellent protocol adherence. We conclude that a larger trial establishing the effectiveness of early prothrombin complex concentrate administration to reduce the use of blood products in the setting of high-risk cardiac surgery is feasible.Trial Registration: ClinicalTrials.gov Identifier: NCT02577614