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NOT YET RECRUITING

NCT06718751

PHASE2

Tranexamic Acid Therapy For The Treatment of Subdural Hematomas

Sponsor: Baylor College of Medicine

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

21 Years - 95 Years

Study Type

INTERVENTIONAL

Enrollment

240

Start Date

2025-10

Completion Date

2030-10

Last Updated

2025-05-14

Healthy Volunteers

Conditions

Chronic Subdural Hematoma

Interventions

DRUG

Tranexamic Acid 650 MG

PO administration of TXA tablet

DRUG

Placebo

PO administration of placebo tablet

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 * Concurrent use of Factor IX complex concentrate or anti-inhibitor coagulant concentrates * Concurrent use of all-trans retinoic acid * Active intravascular clotting or disseminated intravascular coagulation * Need for tissue plasminogen activators * Known hypersenstivity to TXA or any of the ingredients * Acute and chronic renal insufficiency indicated by glomerular filtration rate (GFR) \< 60 mL/min or creatinine \> 2.8 mg/dL * Hematuria, caused by diseases of renal parenchyma * Pregnancy or breastfeeding\* * Concomitant hormonal contraception\* * History of convulsions * History of angioplasty with cardiac stent placement or mechanical heart valve * Any concern from the attending physician

Clinical Research Directory

Tranexamic Acid Therapy For The Treatment of Subdural Hematomas

Summary

Key Details

Conditions

Interventions

Eligibility Criteria