NCT07245264 Adjuvant Tranexamic Acid (TXA) Versus Surgery Alone for Adult Patients With Chronic Subdural Hematoma (CSDH)
| NCT ID | NCT07245264 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | St. Olavs Hospital |
| Condition | Chronic Subdural Hematoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 274 participants |
| Start Date | 2025-12-10 |
| Primary Completion | 2028-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 274 participants in total. It began in 2025-12-10 with a primary completion date of 2028-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is an open label randomized controlled trial. Patients with a symptomatic Chronic Subdural Hematoma (CSDH) confirmed on radiological imaging, planned for surgery, age over 18, free from other intracranial pathologies and no previous intracranial surgery, will be recruited at time of admission. Patients eligible for inclusion will be randomized to receive treatment with Tranexamic acid (TXA) as an adjunct to surgery or surgery alone. Surgical evacuation will be performed using a single or double burr hole and 24 hours postoperative drainage. The primary endpoint will be recurrent hematoma requiring repeat surgery within 90 days. Secondary outcomes will be modified Rankin Scale at 90 days, EQ-5D-5L, complications and adverse events, and 90-day mortality.
Eligibility 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
Contact & Investigator
Chandrashekhar Gendle, MD PhD
STUDY CHAIR
Postgraduate Institute of Medical Education & Research (PGIMER)
Frequently Asked Questions
Who can join the NCT07245264 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Subdural Hematoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07245264 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07245264 currently recruiting?
Yes, NCT07245264 is actively recruiting participants. Contact the research team at chandrashekhargonde@gmail.com for enrollment information.
Where is the NCT07245264 trial being conducted?
This trial is being conducted at Chandigarh, India.
Who is sponsoring the NCT07245264 clinical trial?
NCT07245264 is sponsored by St. Olavs Hospital. The principal investigator is Chandrashekhar Gendle, MD PhD at Postgraduate Institute of Medical Education & Research (PGIMER). The trial plans to enroll 274 participants.