Clinical Trial

Tranexamic Acid Therapy For The Treatment of Subdural Hematomas

Not Yet Recruiting Phase 2
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Summary
This Phase II randomized, placebo-controlled, double-blinded trial is the first step in our endeavor to improve the clinical outcomes of patients with chronic subdural hematomas (cSDH). Patients who are deemed to not need surgery for their cSDH will be randomly assigned to either the treatment group or the placebo group. Both groups will take a 650mg tablet once daily for 21 weeks and follow the standard of care monitoring for cSDH which is neurological testing and imaging at 6 weeks, 12 weeks, and 21 weeks. With this study, we hope to establish the safety and efficacy of using TXA PO to resolve cSDH without the need for surgical intervention.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-12-02.
Trial Details
NCT Number NCT06718751
Lead Sponsor Baylor College of Medicine
Conditions Chronic Subdural Hematoma
Enrollment 240 participants
Start Date 2025-10
Primary Completion 2029-10 (estimated)
Study Completion 2030-10 (estimated)
Updated on ClinicalTrials.gov 2025-05-14