title: Prospective randomized placebo-controlled trial of aprotinin for elective aortic reconstruction.
abstract: BACKGROUND
  The serine protease antagonist, aprotinin, reduces perioperative blood loss in cardiac surgery and orthotopic liver transplantation. A pilot study suggested that the drug may also reduce bleeding during infrarenal aortic replacement; the aim was to confirm or refute this observation with a prospective, randomized, double-blind, placebo-controlled trial.
  
  
  METHODS
  Some 136 patients were randomized to receive either aprotinin, given as a loading dose of 2 x 10(6) kallikrein inactivator (KI) units followed by 0.5 x 10(6) KI units/h or equal volumes of 0.9 per cent saline. After 80 patients had been randomized the infusion dose was doubled to ensure that plasma levels were similar to those seen in successful cardiac studies. Blood loss, coagulation and haematological parameters were recorded throughout surgery and for 7 days afterwards. Blood was transfused to maintain the haemoglobin level at 100 g/l.
  
  
  RESULTS
  Four patients were withdrawn after randomization when found at laparotomy to be unsuitable for the planned reconstruction. The 30-day mortality rate was 4.5 per cent, with no excess complications in either group. Blood loss collected on swabs was reduced from 480 ml in placebo-treated patients to 379 ml with aprotinin (P = 0.014). Blood loss into suction drains in the first 24 h after operation was reduced from 295 to 205 ml in aprotinin-treated patients (P = 0.002). However, no significant reduction was found in intraoperative or total blood loss, or transfusion requirement.
  
  
  CONCLUSIONS
  The small reduction in blood loss in patients treated with aprotinin demonstrated in this study does not support its use in routine elective aortic surgery.
authors.affiliation: Department of Vascular Surgery, Royal South Hants Hospital, Southampton, UK.
authors.forename: C J
authors.initials: CJ
authors.lastname: Ranaboldo
authors.forename: J F
authors.initials: JF
authors.lastname: Thompson
authors.forename: J N
authors.initials: JN
authors.lastname: Davies
authors.forename: A M
authors.initials: AM
authors.lastname: Shutt
authors.forename: J N
authors.initials: JN
authors.lastname: Francis
authors.forename: O S
authors.initials: OS
authors.lastname: Roath
authors.forename: J H
authors.initials: JH
authors.lastname: Webster
authors.forename: A D
authors.initials: AD
authors.lastname: Chant
mesh_terms: D000368:Aged; D001018:Aortic Diseases / Q000601:surgery*; D007611:Aprotinin / Q000627:therapeutic use*; D016063:Blood Loss, Surgical / Q000517:prevention & control*; D001803:Blood Transfusion; D004311:Double-Blind Method; D017558:Elective Surgical Procedures; D005260:Female; D006801:Humans; D008297:Male; D011446:Prospective Studies; D015842:Serine Proteinase Inhibitors / Q000627:therapeutic use*
chemical_list: D015842:Serine Proteinase Inhibitors; D007611:Aprotinin