Safety and efficacy of recombinant activated factor VII: a randomized placebo-controlled trial in the setting of bleeding after cardiac surgery.
This phase II dose-escalation study evaluated the risk/benefit ratio of recombinant activated factor VII (rFVIIa) in 172 cardiac surgery patients who were bleeding postoperatively. These patients were randomized to receive placebo, 40 g/kg rFVIIa, or 80 g/kg rFVIIa. More patients experienced a critical serious adverse event, i.e. a thrombotic event (the primary endpoint criterion), in the rFVIIa group, although significantly fewer patients in the rFVIIa group underwent a reoperation as a result of bleeding or required allogeneic transfusions (statistical significance but low clinical relevance).
The authors conclude that rFVIIa may be beneficial for treating bleeding after cardiac surgery, but caution should be applied and further clinical trials are required because there is an increase in the number of critical serious adverse events, including stroke, in those patients randomized to receive rFVIIa.
– Charles-Marc Samama