Not Yet RecruitingPhase 2

Tranexamic Acid Therapy For The Treatment of Subdural Hematomas

240 participantsStarted 2025-10

Plain-language 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.

Who can participate

Age range

21 Years – 95 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 * Competence to take study medications properly and regularly or access to care giver that is able to comply with accurate study medication administration Exclusion Criteria: * 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) * Active malignancy * Need for chronic therapeutic anticoagulation (i.e. atrial fibrillation) * Acute subdural hematoma with no chronic component * Active treatment for deep vein thrombosis, pulmonary embolism or cerebral thrombosis (secondary prophylaxis is not considered to be active treatment) * Known hereditary thrombophilia, including Factor V Leiden, Antithrombin III mutation, Protein C deficiency, Protein S deficiency * History of thrombosis or thromboembolism, including retinal vein or artery occlusions * An intrinsic risk of thrombosis or thromboembolism * Aneurysmal subarachnoid hemorrhage * Co…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Rate of resolution measured as the cSDH volume or diameter

Timeframe: 6 weeks, 12 weeks, 21 weeks

Trial details

NCT IDNCT06718751

SponsorBaylor College of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-10

Contact for this trial

Omar Tanweer, MD

(713)-798-4696 omar.tanweer@bcm.edu

View on ClinicalTrials.gov More Chronic Subdural Hematoma trials