The effect of ulinastatin on postoperative blood loss in patients undergoing open heart surgery with cardiopulmonary bypass.

This prospective, randomized, double-blind study evaluated the effect of ulinastatin on postoperative blood loss and transfusion requirements of patients undergoing open-heart surgery with cardiopulmonary bypass (CPB) and aortic cross-clamping (ACC). CPB and ACC produce variable systemic inflammatory reactions that are associated with multiorgan dysfunction via leucocytes, especially polymorphonuclear neutrophils (PMNs). PMNs increase blood loss and transfusion requirements. Ulinastatin, a urinary trypsin inhibitor, inhibits PMN activity and reduces the systemic inflammatory response. Patients received either 5000 U/kg ulinastatin or the equivalent volume of normal saline (control group) before ACC. Postoperative blood loss and transfusion requirements were recorded. Duration of intubation and length of stay in the intensive care unit (ICU) were also noted. There were no statistically significant between-group differences in postoperative blood loss and transfusion requirements. Ulinastatin caused a non-significant decrease in duration of intubation. Patients who received ulinastatin had significantly shorter ICU stays than control patients.

RCT Entities:   Population Interventions Outcomes