Tranexamic acid plus surgery versus surgery alone for adults with chronic subdural hematoma
Randomized Trial Comparing Adjuvant Tranexamic Acid Versus Surgery Alone For Chronic Subdural Hematoma
This trial will see if adding tranexamic acid to standard burr-hole surgery lowers the chance an adult's chronic subdural hematoma comes back.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 274 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | St. Olavs Hospital Academic / other |
| Locations | 1 site (Chandigarh) |
| Trial ID | NCT07245264 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults aged 18 or older with symptomatic CSDH >10 mm on CT or MRI who are scheduled for single- or double-burr-hole evacuation and have no contraindication to tranexamic acid are ideal candidates.
Not a fit: Patients with mechanical heart valves, recent pulmonary embolism or myocardial infarction requiring strong antithrombotic therapy, recent intracranial surgery, severe renal impairment, pregnancy or young women under 40, very limited life expectancy, or pre-hemorrhage mRS of 4–5 are unlikely to be eligible or to benefit.
Why it matters
Potential benefit: If successful, adding TXA could lower recurrence and reduce the need for repeat surgery, improving recovery and reducing complications.
How similar studies have performed: Observational studies and a few limited randomized trials have suggested potential benefit of TXA in CSDH, but conclusive evidence from adequately powered RCTs is still lacking.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Chandigarh
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.