title: Recombinant activated coagulation factor VII and bleeding trauma patients.
abstract: BACKGROUND
  Recombinant activated coagulation factor VII (rFVIIa) is increasingly being administered to massively bleeding trauma patients. rFVIIa has been shown to correct coagulopathy and to decrease transfusion requirements. However, there is no conclusive evidence to suggest that rFVIIa improves the survival of these patients. The purpose of this study was to determine whether or not rFVIIa has an effect on the in-hospital survival of massively bleeding trauma patients.
  
  
  METHODS
  A retrospective cohort study was conducted from January 1, 2000 to January 31, 2005, at a Level I trauma center in Toronto, Canada. Inclusion criteria included trauma patients requiring transfusion of 8 or more units of packed red cells within the first 12 hours of admission. The primary exposure of interest was the administration of rFVIIa. Primary outcome was a 24-hour survival and secondary outcome was overall in-hospital survival.
  
  
  RESULTS
  There were 242 trauma patients identified who met inclusion criteria; 38 received rFVIIa. rFVIIa patients were younger, had more penetrating injuries, and fewer head injuries. However, rFVIIa patients required more red cell transfusions initially, and were more acidotic. Administering rFVIIa was associated with improved 24-hour survival, after adjusting for baseline demographics and injury factors. The odds ratio (OR) for survival was 3.4 (1.2-9.8). Furthermore, there was a strong trend toward increased overall in-hospital survival. The OR of in-hospital survival was 2.5 (0.8-7.6). Also, subgroup analysis of rFVIIa patients showed that 24-hour survivors required a slower initial rate of red cell transfusion (4.5 vs. 2.9 units/hr, p = 0.002), had higher platelet counts (175 vs. 121 [x10(-9)/L], p = 0.05) and smaller base deficits (7.1 vs. 14.3, p = 0.001) compared with rFVIIa patients who died during the first 24 hours.
  
  
  CONCLUSIONS
  rFVIIa may be able to improve the early survival of massively bleeding trauma patients. However, surgical control of massive hemorrhage still has primacy, as rFVIIa did not appear efficacious if extremely high red cell transfusion rates were required. Also, correction of acidosis and thrombocytopenia may be important for rFVIIa efficacy. Prospective studies are required.
authors.affiliation: Trauma Program, Department of Surgery, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Canada.
authors.forename: Sandro B
authors.initials: SB
authors.lastname: Rizoli
authors.forename: Bartolomeu
authors.initials: B
authors.lastname: Nascimento
authors.forename: Fahima
authors.initials: F
authors.lastname: Osman
authors.forename: Fernando Spencer
authors.initials: FS
authors.lastname: Netto
authors.forename: Alex
authors.initials: A
authors.lastname: Kiss
authors.forename: Jeannie
authors.initials: J
authors.lastname: Callum
authors.forename: Frederick D
authors.initials: FD
authors.lastname: Brenneman
authors.forename: Lorraine
authors.initials: L
authors.lastname: Tremblay
authors.forename: Homer C
authors.initials: HC
authors.lastname: Tien
mesh_terms: D000328:Adult; D003029:Coagulants / Q000627:therapeutic use*; D015331:Cohort Studies; D017707:Erythrocyte Transfusion; D005167:Factor VII / Q000627:therapeutic use*; D015942:Factor VIIa; D005260:Female; D006470:Hemorrhage / Q000209:etiology / Q000401:mortality* / Q000628:therapy*; D017052:Hospital Mortality; D006801:Humans; D008297:Male; D011994:Recombinant Proteins / Q000627:therapeutic use; D012189:Retrospective Studies; D015599:Trauma Severity Indices; D014947:Wounds and Injuries / Q000150:complications* / Q000401:mortality*
chemical_list: D003029:Coagulants; D011994:Recombinant Proteins; D005167:Factor VII; C103587:recombinant FVIIa; D015942:Factor VIIa