Background: Tranexamic acid is a lysine analogue that acts by blocking the lysine-dependent production of plasmin and resultant fibrinolysis. Plasmin has direct effects on immune function and inflammation, and we have compelling laboratory and clinical evidence demonstrating tranexamic acid may reduce infection risk in surgery.
Design: This multicentre, pragmatic, double-blind, randomised clinical trial will compare the incidence of surgical site infection and red cell transfusion requirements after IV tranexamic acid and placebo in patients undergoing gastrointestinal surgery.
Study intervention: A bolus of study drug, 0.15 ml/kg (TxA 15 mg/kg or matched placebo) before surgical incision, and then infusion at 0.05 ml/kg/h until the end of surgery. All other aspects of anaesthesia and surgery are flexible.
Entry criteria: Adult patients scheduled for elective or semi-elective open or lap-assisted gastrointestinal surgery (oesophageal, gastric, hepatobiliary, pancreatic, colorectal)
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