Study Comparing Surgery Alone Versus Surgery Plus Tranexamic Acid for Adults With Chronic Subdural Hematoma

What this Trial Is About

Researchers are evaluating the use of tranexamic acid TXA alongside surgery in adults with symptomatic chronic subdural hematoma CSDH, a common brain condition often requiring surgical drainage. This open-label randomized controlled trial aims to determine if adding TXA reduces the risk of hematoma coming back and needing repeat surgery within 90 days compared to surgery alone. The study also looks at functional outcomes, quality of life, complications, and mortality within 90 days following surgery. Participants are randomly assigned to receive either standard surgical evacuation using single or double burr holes with 24-hour postoperative drainage, or the same surgery plus TXA treatment. Those in the TXA group receive 1 gram intravenously before surgery and another 1 gram postoperatively, followed by oral TXA 500 mg twice daily for four weeks. Imaging scans are done at baseline, postoperatively, week 4, and optionally at week 12 based on the surgeons decision. During the study, participants will have clinical evaluations including imaging, functional assessments with the Modified Rankin Scale, quality of life questionnaires EQ-5D-5L, and monitoring for complications or adverse events. The main measurement is whether the hematoma recurs requiring another surgery within 90 days. Safety monitoring for TXA-related side effects is included. The total participation period covers surgery and 90 days of follow-up.

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