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Cheap Blood-Clot drug could cut repeat brain surgery risk

NCT ID NCT05713630

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether tranexamic acid (TXA), a cheap drug that prevents blood clots from breaking down, can help people recover from a subdural hematoma—a collection of blood on the brain after a head injury. About 130 adults aged 45 and older with symptoms like headache or confusion will be randomly assigned to receive TXA or a placebo. Researchers will track quality of life, bleeding, and recovery over time to see if TXA reduces the need for repeat surgery and speeds healing.

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 (TXA)
What this could lead to
If it works, this could provide a cheap, widely available drug to reduce repeat bleeding and speed recovery after a subdural hematoma, potentially lowering the need for additional surgeries.
What could go wrong
This is a mid-stage trial with only 130 participants, so results may not apply to everyone. TXA can rarely cause blood clots or allergic reactions, and the drug may not prove better than 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 3

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

Participants

About 130 people

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

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Dec 2030

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

45 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: * Patients aged 45 and older weighing between 45-150 kg diagnosed with symptomatic SDH will be included. SDH is defined as unilateral or bilateral crescentic collection of blood (hyper, iso, or hypodense, or mixed density) of greater than or equals to 8 mm in thickness along the cerebral convexity on CT of the head. Symptomatic SDH patients eligible for inclusion are those with SDH with one or more of the following symptoms attributable to the SDH: headache, gait disturbance, confusion or cognitive decline, limb weakness or numbness/paresthesia, speech or visual disturbance, drowsiness or impaired consciousness, seizures, impaired cognition, or memory loss at the time of assessment. Exclusion Criteria: \- Patients will be excluded for any of the following conditions: 1. Asymptomatic for longer than 72 hours 2. SDH less than 8 mm in maximal thickness 3. Have an acutely deteriorating neurological status (e.g., brain herniation with pupillary dilation, aneurysm rupture, etc.) that is likely to be fatal within 6 hours or less due to a predominantly acute SDH 4. Presence of brain contusion larger than 5 cubic centimeters or subarachnoid hemorrhage (SAH) thicker than 10 mm with Glasgow Coma Scale (GCS)\< 13 5. Patients with primarily interhemispheric or tentorial SDH 6. Hypersensitivity to TXA or any of the placebo ingredients 7. Pregnancy 8. Irregular menstrual bleeding with unidentified cause 9. Known acquired colour vision disturbances 10. Hematuria caused by renal parenchymal disease 11. Acute and chronic renal insufficiency indicated by estimated Glomerular Filtration Rate (eGFR) ≤ 30 mL/min 12. Concomitant intake of birth control pill and/or hormonal replacement therapy, and anti-inhibitor coagulant concentrates (factor VIII inhibitor bypass activity (FEIBA), factor VII, activated factor IX) 13. Consumption coagulopathy/disseminated intravascular coagulation (DIC) in the last 7 days 14. Not competent to take study medication properly and regularly or not having access to caregiver that is able to comply with study medication administration 15. Mechanical heart valve 16. Liver cirrhosis 17. Recent venous and/or arterial thromboembolism within 6 months of study enrolment 18. SDH caused by intracranial hypotension 19. Known thrombophilia (e.g., antiphospholipid syndrome) 20. Any active malignancy: metastatic cancer systemically or to the brain or a primary malignant brain tumour treated within the last 6 months 21. Previous enrolment in this trial for a prior episode 22. Time interval \>3 days from the time of clinical assessment to eligibility assessment 23. Patients weighing \<45 kg or \>150 kg 24. Patients received any amount of TXA upon admittance to hospital prior to enrolment

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Conditions

The condition(s) this trial relates to.

Hematoma, Subdural

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

  • St. Michael's Hospital

    RECRUITING

    Toronto, Ontario, M5B1T8, Canada

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