title: Comprehensive Canadian review of the off-label use of recombinant activated factor VII in cardiac surgery.
abstract: BACKGROUND
  This observational study sought to identify the off-label use pattern of recombinant activated factor VII (rFVIIa) in cardiac surgery and to identify predictors of its effectiveness and risk.
  
  
  RESULTS
  At 18 Canadian centers, 522 nonhemophiliac cardiac surgical patients received rFVIIa during the period 2003 through 2006; data were available, and retrospectively collected, on 503 patients. The median (quartile 1, quartile 3) units of red blood cells transfused from surgery to therapy and in the 24 hours after therapy were 8 (5, 12) and 2 (1, 5), respectively (P<0.0001). Mortality rate was 32%, and mortality or major morbidity rate was 44%. These rates were within expected ranges (mortality, 27% to 35%; mortality or morbidity, 39% to 48%), which were calculated with a separate cohort of cardiac surgical patients who did not receive rFVIIa used as reference. Independent predictors of complications included instability before therapy (multiple inotropes or intra-aortic balloon pump) and increasing red blood cell units transfused before and after therapy. Variables independently associated with nonresponse included abnormal coagulation parameters and >15 red blood cell units transfused before therapy.
  
  
  CONCLUSIONS
  In Canada, rFVIIa is used primarily when standard interventions have failed to control bleeding. In this setting, rFVIIa is associated with reduced blood product transfusions and, after risk adjustment, does not appear to be associated with increased or decreased complication rates. The effectiveness of the drug may be enhanced if it is given early in the course of refractory blood loss in the setting of adequate amounts of circulating coagulation factors.
authors.affiliation: University Health Network, Toronto General Hospital, Department of Anesthesia, EN 3-402, 200 Elizabeth St, Toronto, Ontario, Canada M5G 2C4. keyvan.karkouti@uhn.on.ca
authors.forename: Keyvan
authors.initials: K
authors.lastname: Karkouti
authors.forename: W Scott
authors.initials: WS
authors.lastname: Beattie
authors.forename: Ramiro
authors.initials: R
authors.lastname: Arellano
authors.forename: Tim
authors.initials: T
authors.lastname: Aye
authors.forename: Jean S
authors.initials: JS
authors.lastname: Bussieres
authors.forename: Jeannie L
authors.initials: JL
authors.lastname: Callum
authors.forename: Davy
authors.initials: D
authors.lastname: Cheng
authors.forename: Lee
authors.initials: L
authors.lastname: Heinrich
authors.forename: Blaine
authors.initials: B
authors.lastname: Kent
authors.forename: Trevor W R
authors.initials: TW
authors.lastname: Lee
authors.forename: Charles
authors.initials: C
authors.lastname: MacAdams
authors.forename: C David
authors.initials: CD
authors.lastname: Mazer
authors.forename: Brian
authors.initials: B
authors.lastname: Muirhead
authors.forename: Antoine G
authors.initials: AG
authors.lastname: Rochon
authors.forename: Fraser D
authors.initials: FD
authors.lastname: Rubens
authors.forename: Corey
authors.initials: C
authors.lastname: Sawchuk
authors.forename: Shaohua
authors.initials: S
authors.lastname: Wang
authors.forename: Terrence
authors.initials: T
authors.lastname: Waters
authors.forename: Bill I
authors.initials: BI
authors.lastname: Wong
authors.forename: Terrence M
authors.initials: TM
authors.lastname: Yau
mesh_terms: D000368:Aged; D016063:Blood Loss, Surgical / Q000517:prevention & control*; D002170:Canada; D006348:Cardiac Surgical Procedures / Q000379:methods*; D003625:Data Collection; D017707:Erythrocyte Transfusion / Q000706:statistics & numerical data; D015942:Factor VIIa / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011994:Recombinant Proteins / Q000627:therapeutic use; D012189:Retrospective Studies; D016896:Treatment Outcome
chemical_list: D011994:Recombinant Proteins; C103587:recombinant FVIIa; D015942:Factor VIIa