Tranexamic Acid to Reduce Infection After Gastrointestinal Surgery

• Status: Recruiting
• Trial end date: 2026-01-31
• Target enrollment: 0
• Participant gender: All

Summary

This international, multicentre, pragmatic, double-blind, placebo-controlled, randomised trial of TxA versus placebo will enrol 3,300 patients throughout Australia and internationally. This is an effectiveness trial - some elements of the trial are deliberately left to the perioperative clinicians' discretion in order to reflect usual practice and maximise generalisability.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayside Health
• Collaborator: National Health and Medical Research Council, Australia
• Treatments: Tranexamic Acid

Criteria

Inclusion Criteria:

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

• Age ≥70 years

• ASA physical status 3 or 4

• Known or suspected history of: heart failure, diabetes, peripheral vascular disease, or chronic respiratory disease

• Obesity (BMI ≥30 kg/m2)

• Anaemia (preoperative haemoglobin <130 g/l in males and <120 g/l in females)

• Renal impairment (se. creatinine ≥150mol/l)

• Low albumin (<30 g/L)

Exclusion Criteria:

• Poor spoken and or written language comprehension

• Laparoscopic cholecystectomy and other minor (eg. closure of stoma) surgery

• Pre-existing infection/sepsis

• Known history of: spontaneous pulmonary embolism, arterial thrombosis familial thrombophilia (e.g. Lupus anticoagulant, protein C deficiency, factor V Leiden)