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Simple drug may cut infection risk after major gut surgery

NCT ID NCT04192435

Disease control Sponsor: Bayside Health Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether tranexamic acid, a drug that helps blood clot, can lower the chance of infection after gastrointestinal surgery. Over 3,300 adults at higher risk for complications took part. The goal was to see if the drug reduces surgical site infections compared to a placebo.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

3,300 people

The number who actually took part.

Started

May 2022

Finished

Oct 2025

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 99 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

digestive system disorder Hemorrhage hemorrhagic disease injury nosocomial infection Wound Infection

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anesthesia Bleeding Gastrointestinal complication Healthcare associated infection Infection wound

Contacts and locations

Locations

  • Alfred Hospital

    Melbourne, Victoria, 3004, Australia

More trials for these conditions

Other studies related to the condition(s) this trial covers.