drugset / Trial / NCT06718751

Tranexamic Acid Therapy For The Treatment of Subdural Hematomas

NCT06718751

Phase 2 Not yet recruiting 240 enrolled Baylor College of Medicine
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2025-10
Primary completion
2029-10
Completion
2030-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Tranexamic Acid Small molecule 650 mg Oral

Indications

No indication recorded.