title: Safety and hemostatic effect of recombinant activated factor VII in cirrhotic patients undergoing partial hepatectomy: a multicenter, randomized, double-blind, placebo-controlled trial.
abstract: BACKGROUND
  Coagulopathy caused by cirrhosis may contribute to excessive bleeding during hepatectomy. We evaluated the hemostatic effect and safety of recombinant factor VIIa (rFVIIa) in cirrhotic patients undergoing partial hepatectomy.
  
  
  METHODS
  Patients were randomized to rFVIIa 50 or 100 mug/kg or placebo, administered intravenously 10 minutes before surgery and every second hour during surgery. The primary efficacy end points were the proportion of patients receiving red blood cell (RBC) transfusions and the amount of RBCs transfused. The RBC transfusion trigger was blood loss of 500 mL. Safety end points included thromboembolic and adverse events.
  
  
  RESULTS
  No statistically significant effect of rFVIIa treatment on efficacy end points was observed. Serious and thromboembolic adverse events occurred at similar incidences in the study groups.
  
  
  CONCLUSIONS
  Using blood loss as a transfusion trigger, the efficacy of rFVIIa in reducing the requirement for RBC transfusion was not established in this study. No safety concerns were identified.
authors.affiliation: Department of Abdominal Surgery, Tumor Hospital of Chinese Academy of Medical Sciences, Beijing, China.
authors.forename: Yong-Fu
authors.initials: YF
authors.lastname: Shao
authors.forename: Jia-Mei
authors.initials: JM
authors.lastname: Yang
authors.forename: Gar-Yang
authors.initials: GY
authors.lastname: Chau
authors.forename: Yongyut
authors.initials: Y
authors.lastname: Sirivatanauksorn
authors.forename: Shou-Xian
authors.initials: SX
authors.lastname: Zhong
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Erhardtsen
authors.forename: Supanit
authors.initials: S
authors.lastname: Nivatvongs
authors.forename: Po-Huang
authors.initials: PH
authors.lastname: Lee
mesh_terms: D000328:Adult; D000368:Aged; D004311:Double-Blind Method; D017707:Erythrocyte Transfusion; D015942:Factor VIIa / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006489:Hemostatic Techniques; D006498:Hepatectomy; D006801:Humans; D008103:Liver Cirrhosis / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D012449:Safety
chemical_list: D011994:Recombinant Proteins; D015942:Factor VIIa