Could a simple drug cut repeat brain bleed surgeries?
NCT ID NCT07245264
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
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Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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About 274 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Jun 2029
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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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.
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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Post Graduate Institute of Medical Education & Research
RECRUITINGChandigarh, 160012, India
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Brain bleed surgery: does the drill site matter?