Extended evaluation of recombinant human activated protein C United States Trial (ENHANCE US): a single-arm, phase 3B, multicenter study of drotrecogin alfa (activated) in severe sepsis.

Study Objective: To gather additional 28-day all-cause mortality and safety data among adult patients with severe sepsis who were treated with drotrecogin alfa (activated).

Design: Prospective, single-arm, multicenter clinical trial.

Setting: Eighty-five study sites in the United States and two in Puerto Rico.