title: Determinants of complications with recombinant factor VIIa for refractory blood loss in cardiac surgery.
abstract: OBJECTIVE
  Recombinant factor VIIa (rFVIIa) is being used for refractory, excessive blood loss (EBL) after cardiac surgery, but its safety for this indication is not known.
  
  
  METHODS
  The unadjusted and risk-adjusted adverse event (AE) rates were compared between 114 consecutive cardiac surgical patients who received rFVIIa for refractory EBL and 541 concurrent patients who developed EBL but did not receive rFVIIa. Similarly, timing of rFVIIa therapy was assessed by dichotomizing rFVIIa patients based on median number of red blood cell (RBC) units received before therapy. The measured AE was a composite of death, stroke, renal failure, myocardial infarction, and major vein thrombosis. For risk adjustment, logistic regression models for this outcome were constructed using known predictors of AEs.
  
  
  RESULTS
  The median RBC units transfused before rFVIIa therapy was eight. The AE rates in the untreated, early (< or = 8 U), and late (> 8 U) treated patients were 24% (129/541), 30% (20/66), and 60% (29/48). The risk-adjustment model included total RBC units, pump time, weaning difficulty, gender, weight, and age. The unadjusted and adjusted AE odds ratios (OR) in the treated vs untreated groups were 2.41 [confidence interval (CI) 1.58-3.67; P < 0.0001] and 1.04 (CI 0.60-1.81; P = 0.9). In the rFVIIa group, the adjusted AE OR was lower in the early treated group (OR 0.41; CI 0.18-0.92; P = 0.03).
  
  
  CONCLUSIONS
  In cardiac surgical patients with refractory hemorrhage, rFVIIa therapy is not associated with increased risk of AEs, and early treatment may be associated with better outcomes.
authors.affiliation: University of Toronto, University Health Network, Department of Anesthesia, 3 Eaton North, 200 Elizabeth Street, Toronto, Ontario M5G 2C4, Canada. keyvan.karkouti@uhn.on.ca
authors.forename: Keyvan
authors.initials: K
authors.lastname: Karkouti
authors.forename: Terrence M
authors.initials: TM
authors.lastname: Yau
authors.forename: Sheila
authors.initials: S
authors.lastname: Riazi
authors.forename: Kathleen M
authors.initials: KM
authors.lastname: Dattilo
authors.forename: Marcin
authors.initials: M
authors.lastname: Wasowicz
authors.forename: Massimiliano
authors.initials: M
authors.lastname: Meineri
authors.forename: Stuart A
authors.initials: SA
authors.lastname: McCluskey
authors.forename: Duminda N
authors.initials: DN
authors.lastname: Wijeysundera
authors.forename: Adriaan
authors.initials: A
authors.lastname: van Rensburg
authors.forename: W Scott
authors.initials: WS
authors.lastname: Beattie
mesh_terms: D058186:Acute Kidney Injury / Q000209:etiology; D000367:Age Factors; D000368:Aged; D001835:Body Weight; D006348:Cardiac Surgical Procedures; D002315:Cardiopulmonary Bypass; D002423:Cause of Death; D017707:Erythrocyte Transfusion; D005167:Factor VII / Q000009:adverse effects*; D015942:Factor VIIa; D005260:Female; D006490:Hemostatics / Q000009:adverse effects*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology; D019106:Postoperative Hemorrhage / Q000517:prevention & control*; D011994:Recombinant Proteins / Q000009:adverse effects; D012307:Risk Factors; D012449:Safety; D012737:Sex Factors; D020521:Stroke / Q000209:etiology; D013997:Time Factors; D016896:Treatment Outcome; D020246:Venous Thrombosis / Q000209:etiology
chemical_list: D006490:Hemostatics; D011994:Recombinant Proteins; D005167:Factor VII; C103587:recombinant FVIIa; D015942:Factor VIIa