Tranexamic Acid to Reduce Delirium After Gastrointestinal Surgery: the TRIGS-D Trial

NCT05470816 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: 58/20
• Study Type: interventional
• Target: 826
• Locations: 1 country
• Sites: 1

Brief Summary

Prophylactic TxA administration in patients undergoing major gastrointestinal surgery reduces the incidence of delirium after surgery when compared with placebo. The unifying hypothesis is that systemic and neuro-inflammation lead to neuronal injury and resultant postoperative delirium.

Conditions

Surgical Site Infection; Dementia; Cognition

Outcome Measures

Primary Outcomes (1)

• incidence of delirium in the first 3 days postoperatively

  3D-Confusion Assessment Method (3D-CAM) or CAM-ICU if the Used to measure delirium. Assessments will be conducted twice daily A classification of delirium will be made if both features 1 and 2 are present

  post surgical incision to day 3 (at anytime)obtaining information from the patient, family and staff, and thorough chart review

Secondary Outcomes (7)

• Delirium severity

  post surgical incision to day 3 (inclusive)

• Quality of Life Intergroup differences

  12 months post surgical incision

• Disability

  12 months post surgical incision

• perioperative neurocognitive disorders (NCDs)

  12 months post surgical incision

• Days at home up to 30 days after surgery (DAH30)

  30 days post surgical incision post surgical incision

Study Arms (2)

Tranexamic Acid

ACTIVE COMPARATOR

12 mg/kg, before surgical incision, and then an infusion of 3 mg/kg/h until the end of surgery.

Drug: Tranexamic Acid 100Mg/ml Inj Vial 10ml

Placebo

PLACEBO COMPARATOR

12 mg/kg, before surgical incision, and then an infusion of 3 mg/kg/h until the end of surgery.

Drug: Placebo

Interventions

Tranexamic Acid 100Mg/ml Inj Vial 10ml DRUG

Intervention is from the Tranexamic acid to Reduce Infection after Gastrointestinal Surgery: the TRIGS Trial. A 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

Also known as: Cyklokapron

Tranexamic Acid

Placebo DRUG

Normal saline

Also known as: Normal Saline

Placebo

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients scheduled for elective gastrointestinal (oesophageal, gastric, hepatobiliary, colorectal) surgery
• with 2 or more risk factors for complications:
• age ≥70 years,
• American Society of Anesthesiologists (ASA) physical status 3 or 4,
• heart failure, diabetes,
• chronic respiratory disease,
• obesity (BMI ≥30 kg/m2),
• vascular disease,
• preoperative haemoglobin \<100 g/L,
• renal impairment (se. creatinine ≥150 micromol/L), or low albumin (\<30 g/L).

You may not qualify if:

• Poor spoken and/or written language comprehension,
• laparoscopic and other minor (eg. closure of stoma) surgery,
• pre-existing infection/sepsis,
• history of spontaneous pulmonary embolism or arterial thrombosis,
• current arterial or venous thrombosis,
• familial thrombophilia (e.g. Lupus anticoagulant, protein C deficiency, factor V Leiden),
• contraindication to TxA.

Sponsors & Collaborators

• Bayside Health: lead
• Monash University: collaborator

Study Sites (1)

Alfred Health

Melbourne, Victoria, 3181, Australia

Location

MeSH Terms

Conditions

Surgical Wound Infection; Dementia

Interventions

Tranexamic Acid; Saline Solution

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Paul S Myles, DSci

  Monash University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: TxA blinded for the TRIGS Trial
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Multicentre, randomised, triple-blind, placebo-controlled, clinical trial (a substudy of the TRIGS trial).

Study Record Dates

• First Submitted: July 5, 2022
• First Posted: July 22, 2022
• Study Start: November 1, 2022
• Primary Completion (Estimated): August 13, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Following analysis for the publication
• Access Criteria: Written request

Locations

AU (1)