Tranexamic Acid to Reduce Infection After Gastrointestinal Surgery (TRIGS)

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

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.

Study Overview

• Status: Completed
• Conditions: Bleeding; Anesthesia; Gastrointestinal Complication; Healthcare Associated Infection; Infection Wound
• Intervention / Treatment: Drug: Tranexamic Acid; Drug: Placebos

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.

• Study Type: Interventional
• Enrollment (Actual): 3300
• Phase: Phase 4

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3004
      • Alfred Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Tranexamic acid; At induction of anesthesia and prior to surgical incision a bolus of 0.15 ml/kg ( up to a maximum of 15 ml) , and then commence an infusion of 0.05 ml/kg/h until the end of surgery. The total maximal administered study drug volume will be 30 ml.	Drug: Tranexamic Acid; 100mg/ml
Placebo Comparator: Placebo; At induction of anesthesia and prior to surgical incision a bolus of 0.15 ml/kg ( up to a maximum of 15 ml) , and then commence an infusion of 0.05 ml/kg/h until the end of surgery. The total maximal administered study drug volume will be 30 ml.	Drug: Placebos; Placebo will be 5ml vials calculated to equivalent to the 100mg/ml of active drug.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Surgical Site Infection	defined by the US Centers for Disease Control (CDC)	from surgical incision to 30 days post surgical incision

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Red cell transfusion	Total units given	from surgical incision to hospital discharge (from index surgery) or 30 days.
Other healthcare-associated infections	sepsis, pneumonia, blood stream infection, UTI, etc; all using CDC-guided definitions	from surgical incision to 30 days
C-reactive protein	peak	Postoperative Day 3 (three days after surgical incision)
Days at home up to 30 days after surgery (DAH30).	Time that patient spends at home in the 30 days following surgery	From surgical incision to 30 days

Collaborators and Investigators

• Sponsor: Bayside Health
• Collaborators: National Health and Medical Research Council, Australia
• Investigators: Study Chair: Paul S Myles, MD, DSc, Alfred Hospital and Monash University

Publications and helpful links

General Publications

• O'Higgins N. Endocrine influence on the breast. Ir Med J. 1984 Feb;77(2):49-51. No abstract available.
• Takehara K, Nakabayashi Y, Ishibashi Y, Moroi Y, Aikawa T, Inaba K, Meshizuka K. [Immunologic abnormalities in localized scleroderma]. Nihon Hifuka Gakkai Zasshi. 1984 Feb;94(2):121-8. No abstract available. Japanese.

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2022
• Primary Completion (Actual): September 13, 2025
• Study Completion (Actual): October 20, 2025

Study Registration Dates

• First Submitted: November 27, 2019
• First Submitted That Met QC Criteria: December 8, 2019
• First Posted (Actual): December 10, 2019

Study Record Updates

• Last Update Posted (Actual): December 31, 2025
• Last Update Submitted That Met QC Criteria: December 29, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Iatrogenic Disease; Pathological Conditions, Signs and Symptoms; Hemorrhage; Wound Infection; Cross Infection; Organic Chemicals; Carboxylic Acids; Acids, Carbocyclic; Cyclohexanecarboxylic Acids; Tranexamic Acid
• Other Study ID Numbers: 087

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: This decision will be made on a individual case by case basis, with formal request and review by the PI and steering committee.
• IPD Sharing Time Frame: Before recruitment of final patient
• IPD Sharing Access Criteria: Patient and illness eligibility
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes