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Could a simple drug cut repeat brain bleed surgeries?

NCT ID NCT07245264

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 17, 2026 · Updated 1 time

Summary

This study tests whether adding tranexamic acid (a drug that helps blood clot) to standard surgery can lower the chance of needing another surgery for chronic subdural hematoma, a condition where blood collects around the brain. About 274 adults scheduled for surgery will be randomly assigned to receive either surgery alone or surgery plus the drug. The main goal is to see if the drug reduces repeat operations within 90 days.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 274 people

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

Started

Dec 2025

Expected to finish

Jun 2029

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: 1. Symptomatic chronic subdural hematoma confirmed on computer tomography (CT) or magnetic resonance imaging (MRI) measuring greater than 10 mm thickness. 2. Adult patient ≥18 years 3. Scheduled for single or double burr hole for evacuation. 4. No contraindication for TXA Exclusion criteria 1. Mechanical heart valve 2. Newly diagnosed (last 12 months) pulmonary embolism, myocardial infarction, and strong indication for antithrombotic treatment 3. Intracranial surgery within last 6 months 4. Pregnancy and woman\<40 years 5. Participation in any other clinical trial 6. Life expectancy of less than one year. 7. A score on the modified Rankin scale, designed to assess functional independence, of 4 or 5 (scores range from 0 \[no symptoms\] to 6 \[death\]) before the hematoma occurred. 8. Unfit for participations for any other reason as evaluated by the including physician. 9. History of severe impairment of renal function (eGFR \<30ml/min or serum creatinine \>150μmol/L) 10. Known hypersensitivity or allergy to TXA 11. Inability to obtain informed consent from the patient or legal representative

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Conditions

The condition(s) this trial relates to.

Hematoma, Subdural, Chronic

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  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

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Post Graduate Institute of Medical Education & Research

    RECRUITING

    Chandigarh, 160012, India

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