Background: Drotrecogin alfa (activated) has antithrombotic, antiinflammatory, and profibrinolytic properties. This phase 3 trial was designed to assess if DAA would reduce the rate of death in patients with severe sepsis.
Methods: Randomized, double-blind, placebo-controlled, multicenter trial. Three out of four SIRS criteria and organ failure were used as entry criteria. n = 1690.
Treatment: DAA was started within 24 hours of diagnosis, dosed at 24 micrograms per kilogram per hour for a total of 96 hours.
Results: Mortality was 24.7 v 30.8%. ARR 6.1%, p = 0.005. NNT = 16
Adverse Events: Serious bleeding event was 3.5 v 2.0%. ARI 1.5%, p = 0.06. NNH = 7
Number needed to harm is a little concerning... I think it is important to look up, where were these "serious bleeding events". Consequences are different for GI bleed and for intracranial bleed. I treat 16 pts and prevent 1 death, but I harm 2 pts by inducing iatrogenic serious bleeding - depends where is the bleeding and how I may intervene... Any clinical predictors on who will bleed and where?