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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Prolonged prothrombin time after recombinant activated factor vii therapy in critically bleeding trauma patients is associated with adverse outcomes
Journal of Trauma - Injury, Infection and Critical Care, Volume 69, No. 1, Year 2010
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Description
Background: In trauma patients with significant hemorrhage, it is hypothesized that failure to normalize prothrombin time (PT) after recombinant activated factor VII (rFVIIa) treatment predicts poor clinical outcomes and potentially indicates a need for additional therapeutic interventions. Methods: To assess the value of PT to predict outcomes after rFVIIa or placebo therapy, we performed a post hoc analysis of data from 169 severely injured, critically bleeding trauma patients who had 1-hour postdose PT measurements from two randomized clinical trials. Baseline characteristics and outcome parameters were compared between subjects with 1-hour postdose PT ≥18 seconds and PT <18 seconds. Results: In rFVIIa-treated subjects, prolonged postdose PT values ≥18 seconds were associated with significantly higher 24-hour mortality (60% vs. 3%; p < 0.001) and 30-day mortality, increased incidence of massive transfusion, and fewer intensive care unit-free days compared with postdose PT values <18 seconds. Recombinant rFVIIa-treated subjects with postdose PT ≥18 seconds had significantly lower baseline hemoglobin levels, fibrinogen levels, and platelet counts than subjects with postdose PT values <18 seconds even though they received similar amounts of blood products before rFVIIa dosing. Placebo-treated subjects with postdose PT ≥18 seconds had significantly increased incidence of massive transfusion, significantly decreased intensive care unit-free days, and significantly lower levels of fibrinogen and platelets at baseline compared with subjects with postdose PT values <18 seconds. Conclusions: The presence of prolonged PT after rFVIIa or placebo therapy was associated with poor clinical outcomes. Because subjects with postdosing PT ≥18 seconds had low levels of hemoglobin, fibrinogen, and platelets, this group may benefit from additional blood component therapy. Copyright © 2010 by Lippincott Williams & Wilkins.
Authors & Co-Authors
McMullin, Neil R.
United States, Fort Sam Houston
U.s. Army Institute of Surgical Research
Wade, Charles E.W.
United States, Houston
University of Texas Health Science Center at Houston
Holcomb, John Bradley B.
United States, Houston
University of Texas Health Science Center at Houston
Nielsen, Tina G.
Denmark, Bagsvard
Novo Nordisk A/s
Rossaint, Rolf
Germany, Aachen
Uniklinik Rwth Aachen
Riou, Bruno
France, Paris
Hôpital Universitaire Pitié Salpêtrière
Rizoli, Sandro Baleotti
Canada, Toronto
University of Toronto
Kluger, Yoram S.
Israel, Haifa
Rambam Health Care Campus Israel
Iau, Phillip Tsau Choong
Singapore, Singapore City
National University Hospital
Warren, Brian Leigh
South Africa, Stellenbosch
Stellenbosch University
Tortella, Bartholomew J.
Denmark, Bagsvard
Novo Nordisk A/s
Boffard, Kenneth D.
South Africa, Johannesburg
Charlotte Maxeke Johannesburg Academic Hospital
Statistics
Citations: 12
Authors: 12
Affiliations: 10
Identifiers
Doi:
10.1097/TA.0b013e3181e17260
ISSN:
00225282
e-ISSN:
15298809
Study Design
Randomised Control Trial
Cohort Study