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Tranexamic Acid Therapy For The Treatment of Subdural Hematomas

StatusNot Yet Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Sep 2025 to Oct 2029 Start date: Jan 2025 to Oct 2025 · Enrollment target: 300 to 240 · Completion date: Jan 2026 to Oct 2030v2 Show 3 more changesShow less
    • Start date: Jan 2025 to Oct 2025
    • Enrollment target: 300 to 240
    • Completion date: Jan 2026 to Oct 2030
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06718751
Lead Sponsor Baylor College of Medicine
Conditions Chronic Subdural Hematoma
Enrollment 240 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov