The use of ultra-low-dose aprotinin to reduce blood loss in cardiac surgery.
One hundred patients due to undergo primary cardiac surgery were prospectively randomized to receive aprotinin or placebo. In the aprotinin group, 250,000 kallikrein inhibitory units (KIU) of aprotinin were added to the cardiopulmonary bypass prime solution. A further 250,000 KIU of aprotinin were infused intravenously over 30 minutes immediately before the start of cardiopulmonary bypass. The control group received 0.9% saline in equal volumes at identical times. The study was designed to have a 90% chance of demonstrating a 30% reduction in blood loss. No significant differences were found between the two groups. The median blood loss in the aprotinin group was 750 mL (interquartile range 556 to 1025 mL, 95% confidence interval 600 to 800 mL). In the control group, the median blood loss was also 750 mL (interquartile range 500 to 988 mL, 95% confidence interval 625 to 925 mL). In the aprotinin group, 12 patients received postoperative autotransfusion of shed mediastinal blood of median volume of 665 mL (interquartile range 500 to 925 mL, 95% confidence interval 450 to 1000 mL). In the control group, 14 patients received postoperative autotransfusion of mediastinal blood of median volume of 663 mL (interquartile range 600 to 800 mL, 95% confidence interval 600 to 700 mL). Five patients in the aprotinin group and seven patients in the control group required postoperative homologous blood transfusion. Reassessment of inclusion criteria showed a 19% reduction in blood loss in patients undergoing only aortocoronary bypass receiving aprotinin compared with controls.(ABSTRACT TRUNCATED AT 250 WORDS)