Reduced blood loss by aprotinin in thoracic surgical operations associatedwith high risk of bleeding. A placebo-controlled, randomized phase IV study

Objective: Although the blood-saving effect of aprotinin has been well docu mented in cardiac surgery and lung transplantation, its use in lung surgery has received less attention. We present our experience with the intraopera tive application of aprotinin in lung resections with a predicted high risk of bleeding. Methods: Thirty-eight patients undergoing major thoracic surg ical procedures were randomized into treatment and placebo groups. The trea tment group (n = 18) received a bolus of 2 x 10(6) kallikrein inhibitor uni ts (KIU) of aprotinin followed by 5 x 10(5) KIU/h during surgery. The place bo group (n = 20) received an isotonic saline infusion instead. Results: Th ere was no significant difference between the groups concerning diagnosis, co-morbidity, age, sex, height, and weight. The mean intraoperative blood l oss in the treatment group was significantly reduced (342 vs. 808 ml, P < 0 024), postoperative blood loss was also reduced (623 vs. 1282 ml, P < 0.000 7) and the need for blood transfusion was less (14 vs. 60, n.s.). No severe side effects of aprotinin were registered. Re-thoracotomy was necessary in two patients of the placebo group because of postoperative bleeding. Concl usion: Aprotinin reduces the perioperative blood loss and the need for bloo d transfusion in thoracic surgical procedures in patients with an increased risk of bleeding. (C) 2001 Elsevier Science B.V. All rights reserved.