Tranexamic acid, blood loss and transfusion after valve replacement cardiac surgery: a randomized controlled trial of two modes of administration

Abstract

SUMMARYWe aimed to assess the effect of two different modalities for administering similar doses of tranexamic acid on bleeding following primary elective valve replacement cardiac surgery. In a double‐blinded, prospective, placebo‐controlled design, 209 patients scheduled for aortic, mitral or combined valve replacement were randomized to three groups: one placebo and two treatment groups applying different modalities of tranexamic acid administration (bolus injection of 30 mg/kg vs. continuous infusion). Blood loss up until removal of chest tubes was the primary outcome measure; also recorded and assessed were blood products transfused, need of resternotomy and thrombogenic complications. All groups were comparable at baseline. Blood loss and excessive bleeding were greater in the placebo group than in either treatment group (P < 0.001). Trends toward transfusion differences between groups did not reach statistical significance. No differences in thromboembolic complications, morbidity or mortality were found. In valve replacement cardiac surgery, the use of either method for administering similar doses of tranexamic acid leads to a similarly significant reduction in postoperative mediastinal bleeding, although transfusion needs remained unchanged compared with the placebo group.