Tranexamic acid plus surgery versus surgery alone for adults with chronic subdural hematoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, single-center, open-label randomized controlled trial enrolling adults with symptomatic chronic subdural hematoma planned for burr-hole evacuation. Eligible patients are randomized to receive standard surgery alone or surgery plus adjuvant tranexamic acid given as 2 g IV around the operation followed by oral TXA 500 mg twice daily for four weeks. The primary outcome is recurrence of the ipsilateral hematoma requiring repeat surgery within 90 days; secondary outcomes include 90-day modified Rankin Scale, EQ-5D-5L, complications/adverse events, and 90-day mortality. Surgical technique uses single or double burr holes with 24-hour postoperative drainage, and recurrence requires both clinical deterioration and radiologic confirmation.

Why it matters

Who can join: the full rules

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

Where it's running

• Post Graduate Institute of Medical Education & Research
  Chandigarh, India Recruiting

Study contacts

• Principal investigator: Mattis A Madsbu, MD PhD — St. Olavs University Hospital, Department of Neurosurgery
• Study coordinator: Chandrashekhar Gendle, MD PhD
• Email: chandrashekhargonde@gmail.com
• Phone: +91 98781 52589

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.