title: Recombinant coagulation factor VIIa in major liver resection: a randomized, placebo-controlled, double-blind clinical trial.
abstract: BACKGROUND
  Prevention of bleeding episodes in noncirrhotic patients undergoing partial hepatectomy remains unsatisfactory in spite of improved surgical techniques. The authors conducted a randomized, placebo-controlled, double-blind trial to evaluate the hemostatic effect and safety of recombinant factor VIIa (rFVIIa) in major partial hepatectomy.
  
  
  METHODS
  Two hundred four noncirrhotic patients were equally randomized to receive either 20 or 80 microg/kg rFVIIa or placebo. Partial hepatectomy was performed according to local practice at the participating centers. Patients were monitored for 7 days after surgery. Key efficacy parameters were perioperative erythrocyte requirements (using hematocrit as the transfusion trigger) and blood loss. Safety assessments included monitoring of coagulation-related parameters and Doppler examination of hepatic vessels and lower extremities.
  
  
  RESULTS
  The proportion of patients who required perioperative red blood cell transfusion (the primary endpoint) was 37% (23 of 63) in the placebo group, 41% (26 of 63) in the 20-microg/kg group, and 25% (15 of 59) in the 80-microg/kg dose group (logistic regression model; P = 0.09). Mean erythrocyte requirements for patients receiving erythrocytes were 1,024 ml with placebo, 1,354 ml with 20 microg/kg rFVIIa, and 1,036 ml with 80 microg/kg rFVIIa (P = 0.78). Mean intraoperative blood loss was 1,422 ml with placebo, 1,372 ml with 20 microg/kg rFVIIa, and 1,073 ml with 80 microg/kg rFVIIa (P = 0.07). The reduction in hematocrit during surgery was smallest in the 80-microg/kg group, with a significant overall effect of treatment (P = 0.04).
  
  
  CONCLUSIONS
  Recombinant factor VIIa dosing did not result in a statistically significant reduction in either the number of patients transfused or the volume of blood products administered. No safety issues were identified.
authors.affiliation: St. James's University Hospital, Hospital Haute-Pierre, Strasbourg, France. peterlodge@aol.com
authors.forename: J Peter A
authors.initials: JP
authors.lastname: Lodge
authors.forename: Sven
authors.initials: S
authors.lastname: Jonas
authors.forename: Elie
authors.initials: E
authors.lastname: Oussoultzoglou
authors.forename: Massimo
authors.initials: M
authors.lastname: Malagó
authors.forename: Christian
authors.initials: C
authors.lastname: Jayr
authors.forename: Daniel
authors.initials: D
authors.lastname: Cherqui
authors.forename: Matthias
authors.initials: M
authors.lastname: Anthuber
authors.forename: Darius F
authors.initials: DF
authors.lastname: Mirza
authors.forename: Luce
authors.initials: L
authors.lastname: Kuhlman
authors.forename: Wolf-Otto
authors.initials: WO
authors.lastname: Bechstein
authors.forename: Juan Carlos Meneu
authors.initials: JC
authors.lastname: Díaz
authors.forename: Jack
authors.initials: J
authors.lastname: Tartiere
authors.forename: Daniel
authors.initials: D
authors.lastname: Eyraud
authors.forename: Marianne
authors.initials: M
authors.lastname: Fridberg
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Erhardtsen
authors.forename: Oliver
authors.initials: O
authors.lastname: Mimoz
mesh_terms: D000328:Adult; D000368:Aged; D016063:Blood Loss, Surgical / Q000517:prevention & control; D004311:Double-Blind Method; D015942:Factor VIIa / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D005260:Female; D005767:Gastrointestinal Diseases / Q000139:chemically induced; D006498:Hepatectomy / Q000009:adverse effects / Q000379:methods*; D006801:Humans; D008099:Liver / Q000187:drug effects* / Q000601:surgery*; D008113:Liver Neoplasms / Q000188:drug therapy / Q000601:surgery; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology; D011517:Prothrombin Time / Q000706:statistics & numerical data; D011994:Recombinant Proteins / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D020246:Venous Thrombosis / Q000209:etiology
chemical_list: D011994:Recombinant Proteins; D015942:Factor VIIa