Randomized, multicentre, double-blind, placebo-controlled trial of the use of aprotinin in the repair of ruptured abdominal aortic aneurysm

Abstract

Abstract Background The use of aprotinin in cardiac surgery reduces blood transfusion requirements. The aim of this trial was to see whether the same benefit applies in the repair of ruptured abdominal aortic aneurysm (AAA). Methods In this prospective, randomized trial, nine centres with local ethics committee approval recruited 77 patients with a ruptured AAA. A bolus of aprotinin 2 × 106 units, followed by an infusion of 0·5 × 106 units every 30 min, was administered to 38 patients, and 39 received a placebo infusion. The quantity of blood products transfused during surgery and in the first 12 h after operation was noted, along with the incidence of complications, mortality rates and length of hospital stay. Results Seventeen of the 38 patients who received aprotinin and 17 of the 39 given placebo died within 30 days (overall mortality rate 44 per cent). The median amount of blood given to the aprotinin group after operation was 1 (range 0–14) unit, while for the placebo group it was 3 (range 0–13) units (P = 0·02). However, the difference in the total number of units of blood transfused did not reach significance (10 (range 2–29) versus 14 (range 4–38) units respectively). Conclusion The use of high-dose aprotinin during the repair of a ruptured AAA reduced blood transfusion requirements in the first 12 h after operation, but had no significant effect on the overall blood transfusion requirement.