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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Recombinant activated factor VII as an adjunctive therapy for bleeding control in severe trauma patients with coagulopathy: Subgroup analysis from two randomized trials
Critical Care, Volume 10, Article R178, Year 2006
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Description
Introduction: We conducted a post-hoc analysis on the effect of recombinant factor VIIa (rFVIIa) on coagulopathic patients from two randomized, placebo-controlled, double-blind trials of rFVIIa as an adjunctive therapy for bleeding in patients with severe trauma. Methods: Blunt and penetrating trauma patients were randomly assigned to rFVIIa (200 + 100 + 100 μg/kg) at 0, 1, and 3 hours after transfusion of 8 units of red blood cells (RBCs) or to placebo. Subjects were monitored for 48 hours post-dosing and followed for 30 days. Coagulopathy was retrospectively defined as transfusion of fresh frozen plasma (FFP) (>1 unit of FFP per 4 units of RBCs), FFP in addition to whole blood, and transfusion of platelets and/or cryoprecipitate. Results: Sixty rFVIIa-treated and 76 placebo subjects were retrospectively identified as being coagulopathic. No significant differences were noted in baseline characteristics. The rFVIIa-treated coagulopathic subgroup consumed significantly less blood product: RBC transfusion decreased by 2.6 units for the whole study population (P = 0.02) and by 3.5 units among patients surviving more than 48 hours (P < 0.001). Transfusion of FFP (1,400 versus 660 ml, P < 0.01), platelet (300 versus 100 ml, P = 0.01), and massive transfusions (29% versus 6%, P < 0.01) also dropped significantly. rFVIIa reduced multi-organ failure and/or acute respiratory distress syndrome in the coagulopathic patients (3% versus 20%, P = 0.004), whereas thromboembolic events were equally present in both groups (3% versus 4%, P = 1.00). Conclusion: Coagulopathic trauma patients appear to derive particular benefit from early adjunctive rFVIIa therapy. © 2006 Rizoli et al.; licensee BioMed Central Ltd.
Authors & Co-Authors
Rizoli, Sandro Baleotti
Canada, Toronto
University of Toronto
Boffard, Kenneth D.
South Africa, Johannesburg
Charlotte Maxeke Johannesburg Academic Hospital
Riou, Bruno
France, Paris
Hôpital Universitaire Pitié Salpêtrière
Warren, Brian Leigh
South Africa, Tygerberg
Tygerberg Hospital
Iau, Phillip Tsau Choong
Singapore, Singapore City
National University Hospital
Kluger, Yoram S.
Israel, Haifa
Rambam Health Care Campus Israel
Israel, Tel Aviv-yafo
Sourasky Medical Centre
Rossaint, Rolf
Germany, Aachen
Uniklinik Rwth Aachen
Tillinger, Michael
Denmark, Bagsvard
Novo Nordisk A/s
Nicol, Andrew John
South Africa, Observatory
Groote Schuur Hospital
Tracey, Ralph
South Africa, Centurion
Netcare Unitas Hospital
Marx, J. S.S.
South Africa, Pretoria
Steve Biko Academic Hospital
Degiannis, Elias D.
South Africa, Johannesburg
Chris Hani Baragwanath Hospital
Goosen, Jacques
South Africa, Johannesburg
Milpark Hospital
Plani, Frank
South Africa, Alberton
Union Hospital
Fingleson, L. M.
South Africa, Sandton
Sunninghill Hospital
Payen de La Garanderie, J. F.
France, La Tronche
Hôpital A. Michallon Chu Grenoble
Marty, J.
France, Clichy
Hôpital Beaujon
Krivosic-Horber, R.
France, Lille
Chu Lille
Freysz, Marc
France, Dijon
Hôpital François Mitterrand
De La Coussaye, Jean Emmanuel
France, Nimes
Centre Hospitalier Universitaire de Nîmes
Duranteau, Jacques
France, Le Kremlin-bicetre
Hopital de Bicetre
François, Bruno
France, Limoges
Hopital Dupuytren
Smail, N.
France, Toulouse
Hôpital Purpan
Petit, P.
France, Lyon
Hopital Edouard Herriot
van Aken, H. K.
Germany, Munster
Universitätsklinikum Münster
Hempelmann, G.
Germany, Giessen
Universitätsklinikum Gießen Und Marburg, Standort Gießen
Rivkind, Avraham I.
Israel, Jerusalem
Hadassah University Medical Centre
Shaked, Gad
Israel, Beer Sheva
Soroka University Medical Center
Michaelson, M.
Israel, Haifa
Rambam Health Care Campus Israel
Choong, P. Iau Tsau
Singapore, Singapore City
National University Hospital
Yan, A. Yeo Wan
Singapore, Singapore City
Singapore General Hospital
Hameed, S. Morad
Canada, Calgary
Foothills Medical Centre
Samra, G. S.
United Kingdom, London
The Royal London Hospital
Dobb, Geoffrey J.
Australia, Perth
Royal Perth Hospital
Statistics
Citations: 74
Authors: 34
Affiliations: 33
Identifiers
Doi:
10.1186/cc5133
ISSN:
13648535
e-ISSN:
1466609X
Research Areas
Disability
Study Design
Cross Sectional Study