title: The effect of recombinant activated factor VII on mortality in combat-related casualties with severe trauma and massive transfusion.
abstract: 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 ( degrees 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.
authors.affiliation: US Army Institute of Surgical Research, San Antonio, Texas, USA. pspinella@ccmckids.org
authors.forename: Philip C
authors.initials: PC
authors.lastname: Spinella
authors.forename: Jeremy G
authors.initials: JG
authors.lastname: Perkins
authors.forename: Daniel F
authors.initials: DF
authors.lastname: McLaughlin
authors.forename: Sarah E
authors.initials: SE
authors.lastname: Niles
authors.forename: Kurt W
authors.initials: KW
authors.lastname: Grathwohl
authors.forename: Alec C
authors.initials: AC
authors.lastname: Beekley
authors.forename: Jose
authors.initials: J
authors.lastname: Salinas
authors.forename: Sumeru
authors.initials: S
authors.lastname: Mehta
authors.forename: Charles E
authors.initials: CE
authors.lastname: Wade
authors.forename: John B
authors.initials: JB
authors.lastname: Holcomb
mesh_terms: D001803:Blood Transfusion; D002423:Cause of Death; D016208:Databases, Factual; D015942:Factor VIIa / Q000009:adverse effects / Q000627:therapeutic use*; D006470:Hemorrhage / Q000188:drug therapy* / Q000209:etiology; D006801:Humans; D015601:Injury Severity Score; D053208:Kaplan-Meier Estimate; D008887:Military Medicine; D008889:Military Personnel; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use; D012189:Retrospective Studies; D013927:Thrombosis / Q000209:etiology; D014481:United States; D014857:Warfare; D014947:Wounds and Injuries / Q000145:classification / Q000401:mortality* / Q000628:therapy
chemical_list: D011994:Recombinant Proteins; C103587:recombinant FVIIa; D015942:Factor VIIa