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.

Primary endpoint

Surgical site infection

Secondary endpoints

Include red cell transfusion, other healthcare-associated infections (pneumonia, blood stream infection, etc), and the number of days at home within 30 days of surgery (DAH30).

Safety endpoints

Myocardial infarction, stroke and thromboembolic events; other adverse events.

Entry criteria

Adult patients scheduled for elective or semi-elective open or lap-assisted gastrointestinal surgery (oesophageal, gastric, hepatobiliary, pancreatic, colorectal) with one or more risk factors for complications.

Sample size

3,300 patients

Study duration

5 years


NHMRC project grant

For further information

Please contact Sophie Wallace: or +61 3 9076 2651