NCT04192435

Tranexamic Acid to Reduce Infection After Gastrointestinal Surgery

Tranexamic Acid to Reduce Infection After Gastrointestinal Surgery; The TRIGS Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 3,300 (actual)
• Sponsor: Bayside Health · Other Government
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Study Aims: To conduct a large, multicentre clinical trial of tranexamic acid (TxA), an antifibrinolytic drug routinely used to reduce bleeding in cardiac and some orthopaedic surgery, in 3,300 patients undergoing major gastrointestinal (GI) surgery. Our specific aims are to investigate whether TxA: Aim 1: Reduces surgical site infection ("wound infection"), and other healthcare-associated infections (pneumonia and sepsis). Aim 2: Reduces red cell transfusion in GI surgery. Aim 3: Reduces a pooled composite of any serious postoperative complications, and so increases "days alive and at home up to 30 days after surgery" (DAH30). Aim 4: To evaluate the temporal effect of TxA on perioperative immune and inflammatory responses. Study Hypothesis Prophylactic TxA administration in patients undergoing major GI surgery reduces the incidence of surgical site infection (SSI) after surgery when compared with placebo.

Conditions

• Infection Wound
• Gastrointestinal Complication
• Anesthesia
• Bleeding
• Healthcare Associated Infection

Interventions

Type	Name	Description
DRUG	Tranexamic Acid	100mg/ml
DRUG	Placebos	Placebo will be 5ml vials calculated to equivalent to the 100mg/ml of active drug.

Timeline

• Start date: 2022-05-18
• Primary completion: 2025-09-13
• Completion: 2025-10-20
• First posted: 2019-12-10
• Last updated: 2025-12-31

Locations

1 site across 1 country: Australia