• Angela McLuckie, Duncan Wyncoll, Alison Boyle, Cathrine McKenzie, and Sarah Yassin.
• Institute of Pharmaceutical Sciences, Kings College London and Department of Pharmacy and Critical Care, St Thomas' Hospital, London SE1 7EH, UK. alisonboyle_1@hotmail.com
• J Crit Care. 2012 Jun 1;27(3):320.e7-12.

PurposeLicensed in 2002 for severe sepsis, drotrecogin alfa-activated (DAA) remains a much debated therapy particularly with respect to outcomes and a potentially increased risk of serious bleeding events (SBEs). Recent publications have suggested a significantly increased incidence of SBEs and death in those with baseline bleeding risks (BBRs). Our center is one of the highest prescribers of DAA worldwide; we describe our experience of SBEs and other clinical outcomes.MethodsProspectively collected data using a clinical guideline audit tool and database to track outcome and adverse events of DAA-treated severe sepsis patients were analyzed.ResultsFour hundred ninety-eight patients received DAA over an 8-year period. Hospital, critical care, and 28-day mortalities were 46.2%, 39.6%, and 35.1%, respectively. Contraindications were identified for 40 (8.0%) patients, of whom 24 (4.8%) had BBRs. Hospital mortality was 47.5% (19/40) for patients with any contraindication and 45.8% (11/24) for those with a BBR. Seventy-six (15.3%) bleeding events were reported; 22 (4.4%) were considered serious. Hospital mortality was 60.5% for patients with any bleeding event and 77.3% for those with SBEs.ConclusionsThis large single-center case series demonstrates that DAA has an incidence of SBEs similar to initial clinical trials. As expected, SBEs were associated with a poor outcome.Copyright © 2012 Elsevier Inc. All rights reserved.

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