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The Effect of Recombinant Activated Factor VII on Mortality in Combat-Related Casualties With Severe Trauma and Massive Transfusion

Spinella, Philip C. MD; Perkins, Jeremy G. MD; McLaughlin, Daniel F. MD; Niles, Sarah E. MD, MPH; Grathwohl, Kurt W. MD; Beekley, Alec C. MD; Salinas, Jose PhD; Mehta, Sumeru MD; Wade, Charles E. PhD; Holcomb, John B. MD

The Journal of Trauma: Injury, Infection, and Critical Care: February 2008 - Volume 64 - Issue 2 - p 286-294
doi: 10.1097/TA.0b013e318162759f
Original Articles

Background: The majority of patients with potentially survivable combat-related injuries die from hemorrhage. Our objective was to determine whether the use of recombinant activated factor VII (rFVIIa) decreased mortality in combat casualties with severe trauma who received massive transfusions and if its use was associated with increased severe thrombotic events.

Methods: We retrospectively reviewed a database of combat casualty patients with severe trauma (Injury Severity Score [ISS] >15) and massive transfusion (red blood cell [RBCs] ≥10 units/24 hours) admitted to one combat support hospital in Baghdad, Iraq, between December 2003 and October 2005. Admission vital signs and laboratory data, blood products, ISS, 24-hour and 30-day mortality, and severe thrombotic events were compared between patients who received rFVIIa (rFVIIa+) and did not receive rFVIIa (rFVIIa).

Results: Of 124 patients in this study, 49 patients received rFVIIa and 75 did not. ISS, laboratory values, and admission vitals did not differ between rFVIIa+ and rFVIIa groups, except for systolic blood pressure (mm Hg) 105 ± 33 and 92 ± 28, p = 0.02 and temperature (°F) 96.3 ± 2.1 and 95.2 ± 2.4, p = 0.03, respectively. Interactions between all vital signs and laboratory values measured upon admission, to include systolic blood pressure and temperature, were not significant when measured between rFVIIa use and 30-day mortality. Twenty-four-hour mortality was 7 of 49 (14%) in rFVIIa+ and 26 of 75 (35%) in rFVIIa, (p = 0.01); 30-day mortality was 15 of 49 (31%) and 38 of 75 (51%), (p = 0.03). Death from hemorrhage was 8 of 14 (57%) for rFVIIa+ patients compared with 29 of 37 (78%) for rFVIIa patients, (p = 0.12). The incidence of severe thrombotic events was similar in both groups.

Conclusions: The early use of rFVIIa was associated with decreased 30-day mortality in severely injured combat casualties requiring massive transfusion, but was not associated with increased risk of severe thrombotic events.

From the US Army Institute of Surgical Research (P.C.S., D.F.M., J.S., C.E.W., J.B.H.), San Antonio, Texas; Connecticut Children's Medical Center (P.C.S.), Hartford, Connecticut; Walter Reed Army Medical Center (J.G.P., S.E.N), Washington, District of Columbia; Brooke Army Medical Center (K.W.G., S.M.), San Antonio, Texas; Madigan Army Medical Center (A.C.B.), Tacoma, Washington.

Submitted for publication May 15, 2007.

Accepted for publication November 16, 2007.

The views and opinions expressed in this article are those of the authors and do not reflect the official policy or position of the Army Medical Department, Department of the Army, the Department of Defense, or the United States Government.

Presented at the 66th Annual Meeting of the American Association for the Surgery of Trauma, September 27–29, 2007, Las Vegas, Nevada.

Address for reprints: Philip C. Spinella, MD, Connecticut Children's Medical Center, Pediatric Intensive Care Unit, 282 Washington Street, Hartford, CT 06106; email:

© 2008 Lippincott Williams & Wilkins, Inc.