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.
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
Funding
NHMRC project grant
For further information
Please contact Sophie Wallace: s.wallace@alfred.org.au or +61 3 9076 2651