Adverse events and clinical outcome associated with drotrecogin alfa-activated: A single-center experience of 498 patients over 8 years

Boyle, Alison, McKenzie, Cathrine, Yassin, Sarah, McLuckie, Angela and Wyncoll, Duncan (2012) Adverse events and clinical outcome associated with drotrecogin alfa-activated: A single-center experience of 498 patients over 8 years. Journal of Critical Care, 27 (3), 320.e7-320.e12. (doi:10.1016/J.JCRC.2011.07.004).

Abstract

Purpose
Licensed 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.

Methods
Prospectively collected data using a clinical guideline audit tool and database to track outcome and adverse events of DAA-treated severe sepsis patients were analyzed.

Results
Four 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.

Conclusions
This 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.

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Contributors

Author: Cathrine McKenzie

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