Adjuvant Tranexamic Acid (TXA) Versus Surgery Alone for Adult Patients With Chronic Subdural Hematoma (CSDH)

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.

NCT Number	NCT07245264
Lead Sponsor	St. Olavs Hospital Collaborators: Post Graduate Institute of Medical Education and Research, Chandigarh
Conditions	Chronic Subdural Hematoma
Enrollment	274 participants
Start Date	2025-12-10
Primary Completion	2028-11-01 (estimated)
Study Completion	2029-06-01 (estimated)
Updated on ClinicalTrials.gov	2026-07-17