ENHANCE: Results of a global open-label trial of drotrecogin alfa (activated) in children with severe sepsis*

Abstract

Without a placebo control, no efficacy conclusions are possible. Subgroups at higher risk of death were identified, and the change in protein C level from baseline was predictive of survival. The most significant complication observed was bleeding. Risk factors for serious bleeding appear to be multiple organ failure, thrombocytopenia, and coagulopathy.