High-dose ulinastatin reduces postoperative bleeding and provides platelet-protective effects in patients undergoing heart valve replacement surgery.

Background: The aim of this prospective study was to investigate the effect of a high dose of ulinastatin on platelets and coagulation in patients undergoing mitral valve and/or aortic valve replacement with cardiopulmonary bypass (CPB).

Materials and methods: 273 patients were enrolled in this open-label study. According to patients' willingness, 243 patients were assigned to the ulinastatin group and 30 to the control group. In the ulinastatin group, ulinastatin (300,000 U) was given after the induction of anesthesia, ulinastatin (400,000 U) was added to the CPB pump prime, and then ulinastatin (300,000 U) was administered after weaning from CPB. Complete blood count and coagulation function test were conducted 1 day before surgery and on the first postoperative day. Bleeding and other safety events were recorded during hospitalization.

Results: Less postoperative major bleeding occurred in the ulinastatin group (0.4 vs. 6.7%, p = 0.03). Moreover, 1 day after CPB, platelet count in the ulinastatin group increased significantly compared to that in the control group (157.7 ± 71.0 vs. 132.1 ± 59.6, p = 0.03). Interestingly and contrary to what was expected, activated partial thromboplastin time (APTT) and prothrombin time (PT) did not differ significantly between the two groups. Ulinastatin application did not cause significant increase in total costs (p = 0.89).

Conclusion: In heart valve replacement surgery with CPB, high-dose ulinastatin could reduce postoperative bleeding and promote platelet recovery with no significant additional medical cost.