Abstract
BackgroundMajor 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.MethodsIn 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.ResultsCompared 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 < 0.001) and the volume of allogeneic erythrocyte transfusion (2.57 ± 3.15 unit vs 3.73 ± 4.21 unit, MD-1.16 unit, 95%CI − 2.06 units to − 0.26 units, p = 0.002). The bleeding and transfusion outcomes were comparable between the ulinastatin group and the tranexamic acid group. In-hospital outcomes and 10-year follow-up showed no statistical difference in mortality and major morbidity among groups.ConclusionsUlinastatin reduced post-operative blood loss and allogeneic erythrocyte transfusion in heart surgery with CPB. The mortality and major morbidity was comparable among the groups shown by the 10-year follow-up.Trial registrationThe trial was retrospectively registered on February 2, 2010. Trial registration number: https://www.clinicaltrials.gov Identifier: NCT01060189.
Highlights
Major bleeding and allogeneic transfusion leads to negative outcomes in patients receiving cardiac surgery with cardiopulmonary bypass (CPB)
Open heart surgery with cardiopulmonary bypass (CPB) and aortic cross-clamping produces variable systemic inflammatory reactions [4,5,6,7], which are associated with multi-organ dysfunction via the action of leucocytes, especially polymorphonuclear neutrophils (PMNs) [8]
Twenty patients didn’t meet the inclusion criteria and 35 patients refused to participate. (Fig. 1) The remained 426 patients were randomized to receiving ulinastatin (Group U, n = 142), tranexamic acid (Group T, n = 143), or placebo (Group C, n = 141)
Summary
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 sparse evidence of its effects on blood loss and allogeneic transfusion in this specific population. The PMNs degrade or inhibit the activity of fibrin, fibrinogen, platelets and coagulation factors, [9,10,11] and lead to increased blood loss and demand for transfusion [12]. Ulinastatin shortened activated partial thromboplastin time (aPTT) and activated coagulation time (ACT) in patients undergoing cardiopulmonary bypass [17]. Two small-sized studies showed no improvement in blood loss and transfusion sparing in patients undergoing specific open heart surgery pretreated with ulinastatin [18, 19]
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