Effect of ulinastatin on post-operative blood loss and allogeneic transfusion in patients receiving cardiac surgery with cardiopulmonary bypass: a prospective randomized controlled study with 10-year follow-up

• Published in: Journal of cardiothoracic surgery 2020-05, Vol.15 (1), p.98-11, Article 98
• Main Authors: Zhang, Peng, Lv, Hong, Qi, Xia, Xiao, Wenjing, Xue, Qinghua, Zhang, Lei, Li, Lihuan, Shi, Jia
• Format: Article
• Language: English
• Subjects: Acids; Adolescent; Adult; Aged; Antifibrinolytic agents; Antifibrinolytic Agents - therapeutic use; Aprotinin; Bleeding; Blood; Blood conservation; Blood platelets; Blood transfusion; Cardiac patients; Cardiac Surgical Procedures; Cardiopulmonary Bypass; Cerebral infarction; Coagulation; Coronary artery bypass; Coronary vessels; Double-Blind Method; Erythrocyte Transfusion - statistics & numerical data; Erythrocytes; Female; Follow-Up Studies; Glycoproteins - therapeutic use; Health aspects; Heart; Heart attacks; Heart surgery; Hospitals; Humans; Male; Middle Aged; Morbidity; Mortality; Myocardial infarction; Ostomy; Patients; Postoperative Hemorrhage - diagnosis; Postoperative Hemorrhage - epidemiology; Postoperative Hemorrhage - prevention & control; Postoperative Hemorrhage - therapy; Prospective Studies; Randomization; Renal failure; Respiratory failure; Stroke; Studies; Surgery; Survival analysis; Tranexamic acid; Tranexamic Acid - therapeutic use; Transfusion; Treatment Outcome; Trypsin; Trypsin inhibitors; Trypsin Inhibitors - therapeutic use; Ulinastatin; Young Adult
• ISSN: 1749-8090; 1749-8090
• DOI: 10.1186/s13019-020-01144-9

Major bleeding and allogeneic transfusion leads to negative outcomes in patients receiving cardiac surgery with cardiopulmonary bypass (CPB). Ulinastatin, a urine trypsin inhibitor, relieves systemic inflammation and improves coagulation profiles with however sparse evidence of its effects on blood loss and allogeneic transfusion in this specific population. In this prospective randomized controlled trial, 426 consecutive patients receiving open heart surgery with CPB were randomly assigned into three groups to receive ulinastatin (group U, n = 142), tranexamic acid (group T, n = 143) or normal saline (group C, n = 141). The primary outcome was the total volume of post-operative bleeding and the secondary outcome included the volume and exposure of allogeneic transfusion, the incidence of stroke, post-operative myocardial infarction, renal failure, respiratory failure and all-cause mortality. A ten-year follow-up was carried on to evaluate long-term safety. Compared with placebo, ulinastatin significantly reduced the volume of post-operative blood loss within 24 h (688.39 ± 393.55 ml vs 854.33 ± 434.03 ml MD - 165.95 ml, 95%CI - 262.88 ml to - 69.01 ml, p