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Simple drug may stop Post-Surgery brain fog in High-Risk patients

NCT ID NCT05470816

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests whether giving tranexamic acid before major gastrointestinal surgery can lower the chance of delirium (sudden confusion) after the operation. Delirium is common in older or sicker patients and may be caused by inflammation harming the brain. The trial includes 826 adults with two or more risk factors, such as age 70+ or diabetes, and compares the drug to a placebo. The goal is to see if this simple, safe medication can protect brain function and improve recovery.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 826 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2022

Expected to finish

Aug 2026

An estimate. End dates often move.

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 100 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 * 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). * Written informed consent will be obtained. Exclusion criteria * 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.

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Conditions

The condition(s) this trial relates to.

cognitive disorder dementia Surgical Wound Infection

As listed by the trial registrant

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

Cognition Dementia Surgical site infection

Contacts and locations

Locations

  • Alfred Health

    Melbourne, Victoria, 3181, Australia

More trials for these conditions

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