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Drotrecogin alfa (activated): diffusion from clinical trials to clinical practice
1Glan Clwyd Hospital, Department of Anaesthesia and Intensive Care, Rhyl, Denbighshire, UK. saxon@ridley.waitrose.com
European Journal of Anaesthesiology
|November 23, 2007
Summary
This audit reviewed drotrecin alfa (activated) use in England. Results suggest drotrecin alfa (activated) may reduce mortality in sepsis patients, despite mixed trial outcomes.
Area of Science:
- Critical Care Medicine
- Pharmacology
- Clinical Audit
Background:
- Drotrecogin alfa (activated) showed mortality benefit in PROWESS trial.
- Subsequent studies yielded conflicting results regarding its effectiveness.
- Concerns exist about clinical effectiveness outside of trial settings.
Purpose of the Study:
- To audit the clinical impact of drotrecogin alfa (activated) in real-world settings.
- To evaluate its effectiveness in patients treated outside of clinical trials.
- To assess mortality and adverse events associated with its use.
Main Methods:
- Retrospective review of ICU charts and medical records.
- Inclusion of patients who received drotrecogin alfa (activated) in England.
- Assessment of patient characteristics, severity of illness (APACHE II), organ dysfunction, and vital status.
Main Results:
- 351 patients received drotrecogin alfa (activated) between 2002-2005.
- Mean APACHE II score was 23.3; average 3.3 dysfunctional organs.
- Hospital mortality was 46.7%, lower than expected based on severity scores.
Conclusions:
- Data suggests drotrecogin alfa (activated) may reduce mortality in sepsis.
- Serious adverse incidents occurred in 5.1% of patients.
- Causality of adverse events directly linked to drotrecogin alfa (activated) could not be established.
