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Tranexamic Acid to Reduce Infection After Gastrointestinal Surgery

NCT04192435 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 3300

Last updated 2025-12-31

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

Tranexamic Acid

100mg/ml

DRUG

Placebos

Placebo will be 5ml vials calculated to equivalent to the 100mg/ml of active drug.

Sponsors & Collaborators

  • National Health and Medical Research Council, Australia

    collaborator OTHER

  • Bayside Health

    lead OTHER_GOV

Principal Investigators

  • Paul S Myles, MD, DSc · Alfred Hospital and Monash University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-18
Primary Completion
2025-09-13
Completion
2025-10-20

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04192435 on ClinicalTrials.gov