Randomized Trial Comparing Adjuvant Tranexamic Acid Versus Surgery Alone For Chronic Subdural Hematoma
Status:
RECRUITING
Trial end date:
2029-06-01
Target enrollment:
Participant gender:
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.
Phase:
PHASE2
Details
Lead Sponsor:
St. Olavs Hospital
Collaborator:
Post Graduate Institute of Medical Education and Research, Chandigarh