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Can a common bleeding drug prevent wound problems after ankle replacement?

NCT ID NCT07828262

Prevention Sponsor: Ottawa Hospital Research Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 18, 2026 · Last updated Sep 18, 2026

Summary

Researchers are testing whether tranexamic acid, a drug used to reduce bleeding, can lower the risk of wound healing problems after total ankle replacement surgery. About 40 patients having ankle replacement will be randomly assigned to receive either tranexamic acid or a saltwater placebo during and after surgery. Neither the patients nor their doctors will know which treatment was given. The study will track wound healing, infections, and additional surgeries for six months to see if a larger trial is feasible and whether the drug might help recovery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
tranexamic acid, a drug that helps reduce bleeding
What this could lead to
If it works, tranexamic acid could become a routine addition to ankle replacement surgery to lower the risk of wound problems and repeat operations.
What could go wrong
This is a small pilot study of 40 people, so it may not show a clear benefit or may not be large enough to detect rare side effects. Tranexamic acid can cause allergic reactions or blood clots in some patients.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 40 people

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

Expected to start

Dec 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 years and older

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: * Patient undergoing either primary or revision ankle replacement surgery * Patient is considered to benefit from surgical management at the treating surgeon's discretion * The patient is willing and able to provide written informed consent * The patient is willing and able to comply with post-operative rehabilitation protocols and all follow-up visits Exclusion Criteria: * Pregnant or breastfeeding patient * Uncontrolled diabetes (HgbA1C \> 8) * Known allergy or contraindication for tranexamic acid use including: presence of coronary stents, cerebrovascular event in the last six months, known thromboembolic disorder, hepatic dysfunction, impaired renal clearance, medications with known drug interactions\*\*\* * Lateral-based ankle replacement system * Patient receiving anticoagulation therapy * Investigator concerns about study compliance * Medically unfit for surgery or anesthetic * Acquired color vision problems that are not genetics * There are potential drug-drug interactions leading to myocardial infarction after coadministration of tranexamic acid with hormonal contraceptives, hydrochlorothiazide, desmopressin, sulbactam-ampicillin, carbazochrome, ranitidine, or nitroglycerin. Therefore, patients on these medications will be excluded.

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Conditions

The condition(s) this trial relates to.

Wound Infection

As listed by the trial registrant

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

Ankle arthritis Wound complication

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • The Ottawa Hospital Civic Campus

    Ottawa, Ontario, K1Y 4E9, Canada

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