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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Results of the control trial: Efficacy and safety of recombinant activated factor VII in the management of refractory traumatic hemorrhage
Journal of Trauma - Injury, Infection and Critical Care, Volume 69, No. 3, Year 2010
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Description
Background: Traumatic coagulopathy contributes to early death by exsanguination and late death in multiple organ failure. Recombinant Factor VIIa (rFVIIa, NovoSeven) is a procoagulant that might limit bleeding and improve trauma outcomes. Methods: We performed a phase 3 randomized clinical trial evaluating efficacy and safety of rFVIIa as an adjunct to direct hemostasis in major trauma. We studied 573 patients (481 blunt and 92 penetrating) who bled 4 to 8 red blood cell (RBC) units within 12 hours of injury and were still bleeding despite strict damage control resuscitation and operative management. Patients were assigned to rFVIIa (200 μg/kg initially; 100 μg/kg at 1 hour and 3 hours) or placebo. Intensive care unit management was standardized using evidence-based trauma "bundles" with formal oversight of compliance. Primary outcome was 30-day mortality. Predefined secondary outcomes included blood products used. Safety was assessed through 90 days. Study powering was based on prior randomized controlled trials and large trauma center databases. Results: Enrollment was terminated at 573 of 1502 planned patients because of unexpected low mortality prompted by futility analysis (10.8% vs. 27.5% planned/predicted) and difficulties consenting and enrolling sicker patients. Mortality was 11.0% (rFVIIa) versus 10.7% (placebo) (p = 0.93, blunt) and 18.2% (rFVIIa) versus 13.2% (placebo) (p = 0.40, penetrating). Blunt trauma rFVIIa patients received (mean ± SD) 7.8 ± 10.6 RBC units and 19.0 ± 27.1 total allogeneic units through 48 hours, and placebo patients received 9.1 ± 11.3 RBC units (p = 0.04) and 23.5 ± 28.0 total allogeneic units (p = 0.04). Thrombotic adverse events were similar across study cohorts. Conclusions: rFVIIa reduced blood product use but did not affect mortality compared with placebo. Modern evidence-based trauma lowers mortality, paradoxically making outcomes studies increasingly difficult. Copyright © 2010 by Lippincott Williams & Wilkins.
Authors & Co-Authors
Hauser, Carl Jeffrey
United States, Boston
Beth Israel Deaconess Medical Center
Boffard, Kenneth D.
South Africa, Johannesburg
Charlotte Maxeke Johannesburg Academic Hospital
Dutton, Richard P.
United States, Baltimore
University of Maryland School of Medicine
Bernard, Gordon R.
United States, Nashville
Vanderbilt University School of Medicine
Croce, Martin A.
United States, Memphis
University of Tennessee Health Science Center
Holcomb, John Bradley B.
United States, Houston
University of Texas Health Science Center at Houston
Leppäniemi, Ari Kalevi
Finland, Helsinki
Helsingin Yliopisto
Parr, Michael J.A.
Australia, Sydney
Unsw Sydney
Vincent, Jean Louis
Belgium, Brussels
Hôpital Erasme
Tortella, Bartholomew J.
United States, Plainsboro
Novo Nordisk Inc.
Dimsits, Jeannett
Denmark, Bagsvard
Novo Nordisk A/s
Bouillon, Bertil
Germany, Witten
Universität Witten/herdecke
Statistics
Citations: 339
Authors: 12
Affiliations: 12
Identifiers
Doi:
10.1097/TA.0b013e3181edf36e
ISSN:
00225282
e-ISSN:
15298809
Research Areas
Violence And Injury
Study Design
Randomised Control Trial
Cohort Study