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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Recombinant activated factor VII safety in trauma patients: Results from the CONTROL trial
Journal of Trauma - Injury, Infection and Critical Care, Volume 71, No. 1, Year 2011
Notification
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Description
BACKGROUND: Safety data on recombinant activated factor VII (rFVIIa, NovoSeven; Novo Nordisk A/S, Bagsværd, Denmark) in actively hemorrhaging trauma patients are limited. We present detailed safety data from a large multicenter, randomized, placebo-controlled phase III study (the CONTROL trial). METHODS: Data from 560 patients were analyzed. Subjects were monitored for adverse events (AEs) after rFVIIa or placebo administration. Incidences, timing, and presence of risk factors were reported by site investigators, supported by external study monitors and overseen by an independent Data Monitoring Committee. RESULTS: There were no differences in overall mortality, organ system failure, or AEs, serious AEs, or medical events of special interest. Arterial and venous thromboembolic (TE) events and their risk factors were similar in both groups. The greatest risk factor for TE events was a chest injury requiring mechanical ventilation >3 days (86%). There were four site investigator-reported myocardial infarctions in the rFVIIa group of which only one met diagnostic criteria preestablished by the Data Monitoring Committee. There were no reported myocardial infarctions in the placebo group. Troponins were increased in 30% of all patients. The rate of acute respiratory distress syndrome was lower in the rFVIIa (3.0%) than in the placebo (7.2%) group (p = 0.022). CONCLUSIONS: This represents the largest placebo-controlled dataset of rFVIIa use in trauma patients to date. In this prospective study of critically bleeding trauma patients, rFVIIa use was associated with an imbalance of investigator-reported Acute myocardial infarction/non-ST segment elevation myocardial infarction (AMI/NSTEMI), but was not associated with an increased risk for other AEs, including TE complications. Copyright © 2011 by Lippincott Williams & Wilkins.
Authors & Co-Authors
Dutton, Richard P.
United States, Baltimore
University of Maryland School of Medicine
Parr, Michael J.A.
Australia, Sydney
Unsw Sydney
Tortella, Bartholomew J.
United States, Plainsboro
Novo Nordisk Inc.
Champion, Howard R.
United States, Bethesda
Uniformed Services University of the Health Sciences
Bernard, Gordon R.
United States, Nashville
Vanderbilt University
Boffard, Kenneth D.
South Africa, Johannesburg
Charlotte Maxeke Johannesburg Academic Hospital
Bouillon, Bertil
Germany, Witten
Universität Witten/herdecke
Croce, Martin A.
United States, Memphis
University of Tennessee Health Science Center
Dimsits, Jeannett
Denmark, Bagsvard
Novo Nordisk A/s
Holcomb, John Bradley B.
United States, Houston
University of Texas Health Science Center at Houston
Leppäniemi, Ari Kalevi
Finland, Helsinki
Helsingin Yliopisto
Vincent, Jean Louis
Belgium, Brussels
Hôpital Erasme
Hauser, Carl Jeffrey
United States, Boston
Beth Israel Deaconess Medical Center
Statistics
Citations: 13
Authors: 13
Affiliations: 13
Identifiers
ISSN:
00225282
e-ISSN:
15298809
Research Areas
Violence And Injury
Study Design
Cohort Study