Recombinant coagulation factor VIIa in major liver resection: a randomized, placebo-controlled, double-blind clinical trial.
Liver surgery is known to be associated with significant blood loss and high requirement of blood products support, and rFVIIa has been shown in a few case reports to reduce blood loss following hepatic surgery. In this randomized placebo-controlled clinical trial, 200 patients who underwent partial hepatectomy were randomized to receive placebo, 20 g/kg or 80 g/kg rFVIIa before skin incision. Although there was a trend towards reduced blood loss and transfusion support with the 80 g/kg group, the results were not significantly different. This may be due to the fact that the study was powered to detect a 50% relative reduction in endpoints, in addition to the fact that rFVIIa may have shown more efficacy if administered later on during surgery. There was no difference in incidence of thromboembolic events in the three groups.
– Maadh Aldouri