title: Aprotinin and transfusion requirements in orthotopic liver transplantation: a multicentre randomised double-blind study. EMSALT Study Group.
abstract: BACKGROUND
  Intraoperative hyperfibrinolysis contributes to bleeding during adult orthotopic liver transplantation. We aimed to find out whether aprotinin, a potent antifibrinolytic agent, reduces blood loss and transfusion requirements.
  
  
  METHODS
  We did a randomised, double-blind, placebo-controlled trial in which six liver-transplant centres participated. Patients undergoing primary liver transplantation were randomly assigned intraoperative high-dose aprotinin, regular-dose aprotinin, or placebo. Primary endpoints were intraoperative blood loss and transfusion requirements. Secondary endpoints were perioperative fluid requirements, postoperative blood transfusions, complications, and mortality.
  
  
  RESULTS
  137 patients received high-dose aprotinin (n=46), regular-dose aprotinin (n=43), or placebo (n=48). Intraoperative blood loss was significantly lower in the aprotinin-treated patients, with a reduction of 60% in the high-dose group and 44% in the regular-dose group, compared with the placebo group (p=0.03). Total amount of red blood cell (homologous and autologous) transfusion requirements was 37% lower in the high-dose group and 20% lower in the regular-dose group, than in the placebo group (p=0.02). Thromboembolic events occurred in two patients in the high-dose group, none in the regular-dose group, and in two patients in the placebo group (p=0.39). Mortality at 30 days did not differ between the three groups (6.5%, 4.7%, and 8.3%; p=0.79).
  
  
  CONCLUSIONS
  Intraoperative use of aprotinin in adult patients undergoing orthotopic liver transplantation significantly reduces blood-transfusion requirements and should be routinely used in patients without contraindications.
authors.affiliation: Department of Surgery, Leiden University Medical Centre, The Netherlands. r.j.porte@chir.azg.nl
authors.forename: R J
authors.initials: RJ
authors.lastname: Porte
authors.forename: I Q
authors.initials: IQ
authors.lastname: Molenaar
authors.forename: B
authors.initials: B
authors.lastname: Begliomini
authors.forename: T H
authors.initials: TH
authors.lastname: Groenland
authors.forename: A
authors.initials: A
authors.lastname: Januszkiewicz
authors.forename: L
authors.initials: L
authors.lastname: Lindgren
authors.forename: G
authors.initials: G
authors.lastname: Palareti
authors.forename: J
authors.initials: J
authors.lastname: Hermans
authors.forename: O T
authors.initials: OT
authors.lastname: Terpstra
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D007611:Aprotinin / Q000008:administration & dosage* / Q000009:adverse effects; D016063:Blood Loss, Surgical / Q000503:physiopathology; D001803:Blood Transfusion; D002423:Cause of Death; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005342:Fibrinolysis / Q000187:drug effects; D006490:Hemostatics / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D007262:Infusions, Intravenous; D016031:Liver Transplantation; D008297:Male; D008875:Middle Aged; D019106:Postoperative Hemorrhage / Q000188:drug therapy / Q000401:mortality; D015996:Survival Rate
chemical_list: D006490:Hemostatics; D007611:Aprotinin