Safety and Efficacy of Recombinant Activated Factor VII A Randomized Placebo-Controlled Trial in the Setting of Bleeding After Cardiac Surgery

Background— Blood loss is a common complication of cardiac surgery. Evidence suggests that recombinant activated factor VII (rFVIIa) can decrease intractable bleeding in patients after cardiac surgery. Our objective was to investigate the safety and possible benefits of rFVIIa in patients who bleed after cardiac surgery. Methods and Results— In this phase II dose-escalation study, patients who had undergone cardiac surgery and were bleeding were randomized to receive placebo (n=68), 40 μg/kg rFVIIa (n=35), or 80 μg/kg rFVIIa (n=69). The primary end points were the number of patients suffering critical serious adverse events. Secondary end points included rates of reoperation, amount of blood loss, and transfusion of allogeneic blood. There were more critical serious adverse events in the rFVIIa groups. These differences did not reach statistical significance (placebo, 7%; 40 μg/kg, 14%; P=0.25; 80 μg/kg, 12%; P=0.43). After randomization, significantly fewer patients in the rFVIIa group underwent a reoper...