Pediatr Crit Care Me
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Pediatr Crit Care Me · May 2006
Multicenter StudyENHANCE: results of a global open-label trial of drotrecogin alfa (activated) in children with severe sepsis.
To gather additional 28-day all-cause mortality data and safety information for pediatric patients with severe sepsis who received drotrecogin alfa (activated) (DrotAA). ⋯ 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.