Aprotinin, a serine protease inhibitor, has recently been shown to reduce blood loss in cardiac surgical patients. Data on the safety and efficacy of aprotinin therapy administered to 671 cardiac surgical patients in 41 United Kingdom cardiac surgical units have been submitted to interim analysis. The patients studied were in high-risk categories for excessive bleeding, including 457 redo operations and 79 patients with active infective endocarditis. Overall mortality was 12% in redo cases and 5.1% in first-time operations. Adverse events were reported in only 20 patients (3%). Median blood loss at 24 hours after operation was 400 mL, and median transfusion volume throughout the operative and postoperative period was 2 units. These data confirm that the use of aprotinin therapy in high-risk cardiac surgical patients is associated with a low incidence of adverse events.