Tranexamic Acid Therapy For The Treatment of Subdural Hematomas

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age21-95
SponsorBaylor College of Medicine

About this trial

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.

Eligibility criteria

Qualifiers

CT scan demonstrating existence of a subdural hematoma, unilateral or bilateral, containing a chronic component

Neurosurgeon evaluation deemed patient to not need surgery

Diagnosis within the last 14 days

Signed informed consent

Disqualifiers

Planned surgery, burr-hole craniostomy or mini-craniotomy for their chronic subdural hematoma based on one or more of the following symptoms: medically intractable headache, midline shift >5mm, SDH thickness >10mm, increased ICP, imminent death within 24 hours

Structural causes for subdural hemorrhage (arachnoid cysts, cortical vascular malformations)

Recent ischemic stroke

Other concomitant intracranial pathology (intracranial malignancy)

Trial design

Treatments tested in this trial

  • Tranexamic Acid 650 MG
  • Placebo

Treatment groups

240 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators