title: Recombinant activated factor VII use in critically ill infants with active hemorrhage.
abstract: BACKGROUND
  Recombinant activated factor VII (rFVIIa) is infrequently used off-label in infants despite a paucity of data in this population. We report a retrospective review of rFVIIa use in infants focusing on safety and efficacy.
  
  
  METHODS
  Between 2002 and 2007, 32 critically ill nonhemophiliac infants less than 1 year old received rFVIIa at our institution. Indications of rFVIIa and post-rFVIIa venous thrombosis were reviewed. Transfusion requirements were calculated 8 hours before and after rFVIIa administration.
  
  
  RESULTS
  Infants received on average 2 doses of rFVIIa at a mean dosage of 90 microg/kg. Active hemorrhage was the indication for rFVIIa in 24 infants, which included postoperative bleeding in 16 and nonsurgical bleeding in 8. The remaining 8 infants had preoperative coagulopathy. Thrombosis was noted in 4 infants (13%) and was not related to transfusion requirements, the number of doses, or dosage of rFVIIa. For infants who had active hemorrhage, rFVIIa was able to significantly reduce the requirements of packed red blood cells by 36.17 mL/kg (P < .005), platelets by 10.31 mL/kg (P < .01), and cryoprecipitates by 2.19 mL/kg (P < .05).
  
  
  CONCLUSIONS
  This is the first large case series demonstrating the efficacy of rFVIIa in critically ill infants with active hemorrhage by reducing their transfusion requirements. Furthermore, venous thrombosis was not associated with increase in either the number of doses or dosage of rFVIIa.
authors.affiliation: Division of Pediatric Surgery, UCLA School of Medicine-Mattel Children's Hospital, Los Angeles, CA 90095-7098, USA.
authors.forename: Howard
authors.initials: H
authors.lastname: Jen
authors.forename: Stephen
authors.initials: S
authors.lastname: Shew
mesh_terms: D016913:Blood Component Transfusion / Q000191:economics / Q000706:statistics & numerical data; D003422:Critical Care / Q000191:economics / Q000706:statistics & numerical data*; D016638:Critical Illness; D005169:Factor VIII / Q000191:economics / Q000627:therapeutic use; D015942:Factor VIIa / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use*; D005260:Female; D005340:Fibrinogen / Q000191:economics / Q000627:therapeutic use; D006470:Hemorrhage / Q000188:drug therapy*; D006490:Hemostatics / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use*; D006801:Humans; D007223:Infant; D008297:Male; D019106:Postoperative Hemorrhage / Q000188:drug therapy; D011994:Recombinant Proteins / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use; D012189:Retrospective Studies; D020246:Venous Thrombosis / Q000139:chemically induced
chemical_list: D006490:Hemostatics; D011994:Recombinant Proteins; C026912:cryoprecipitate coagulum; D005169:Factor VIII; D005340:Fibrinogen; C103587:recombinant FVIIa; D015942:Factor VIIa