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Unraveling Severe Sepsis
Why Did OPTIMIST Fail and What's Next?
Derek C. Angus, MD, MPH;
Mark A. Crowther, MD, MSc
JAMA. 2003;290:256-258.
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In this issue of THE JOURNAL, Abraham and colleagues1 report the results of an international, multicenter randomized controlled trial (optimized phase 3 tifacogin in multicenter international sepsis trial [OPTIMIST]) that compared a 96-hour infusion of recombinant tissue factor pathway inhibitor (TFPI) with placebo in 1754 critically ill patients with sepsis and mild coagulopathy (international normalized ratio [INR]  1.2). Tissue factor pathway inhibitor, a naturally occurring anticoagulant, modulated the coagulation cascade but did not impact the mortality rate.
Perhaps the most surprising observation in this trial is the pattern of survival. A planned interim analysis of the first 722 patients demonstrated a large difference in the mortality rate favoring patients assigned to receive TFPI (38.9% vs 29.1%, P = .006). However, the survival difference was not large enough to activate the predefined stopping rules and the study continued. Subsequently, survival in . . . [Full Text of this Article]
Author Affiliation: Department of Critical Care Medicine, Clinical Research, Investigation, and Systems Modeling of Acute Illness (CRISMA) Laboratory, University of Pittsburgh, Pittsburgh, Pa (Dr Angus), and Department of Medicine, McMaster University, Hamilton, Ontario (Dr Crowther).
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Efficacy and Safety of Tifacogin (Recombinant Tissue Factor Pathway Inhibitor) in Severe Sepsis: A Randomized Controlled Trial
Edward Abraham, Konrad Reinhart, Steven Opal, Ignace Demeyer, Christopher Doig, Angel López Rodriguez, Richard Beale, Petr Svoboda, Pierre Francois Laterre, Stuart Simon, Bruce Light, Herbert Spapen, Judy Stone, Allan Seibert, Claus Peckelsen, Cathy De Deyne, Russell Postier, Ville Pettilä, Antonio Artigas, Sandra R. Percell, Vincent Shu, Christian Zwingelstein, Jeffrey Tobias, Lona Poole, James C. Stolzenbach, and Abla A. Creasey
JAMA. 2003;290(2):238-247.
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