Tranexamic Acid Therapy For The Treatment of Subdural Hematomas

NCT06718751 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: H-55608
• Study Type: interventional
• Target: 240
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Chronic Subdural Hematoma

Keywords

tranexamic acid

Outcome Measures

Primary Outcomes (1)

• Rate of resolution measured as the cSDH volume or diameter

  6 weeks, 12 weeks, 21 weeks

Secondary Outcomes (7)

• cSDH volume (measured as volume or diameter on follow-up CT scan of the head)

  6 weeks, 12 weeks, 21 weeks

• Proportion of patients needing surgery

  12 weeks, 12 weeks, 21 weeks

• Hematoma recurrence Hematoma recurrence

  12 weeks, 12 weeks, 21 weeks

• Neurological outcome assessed by NIHSS

  6 weeks, 12 weeks, 21 weeks

• Functional outcome assessed by mRS

  6 weeks, 12 weeks, 21 weeks

Study Arms (2)

PO 650mg TXA tablet

EXPERIMENTAL

650mg tablets of TXA will be prescribed to be taken orally, once daily for 21 weeks.

Drug: Tranexamic Acid 650 MG

PO 650mg placebo tablet

PLACEBO COMPARATOR

650mg placebo tablet will be prescribed to be taken orally, once daily for 21 weeks.

Drug: Placebo

Interventions

Tranexamic Acid 650 MG DRUG

PO administration of TXA tablet

PO 650mg TXA tablet

Placebo DRUG

PO administration of placebo tablet

PO 650mg placebo tablet

Eligibility Criteria

• Age: 21 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Baylor College of Medicine: lead

MeSH Terms

Conditions

Hematoma, Subdural, Chronic

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Hematoma, Subdural; Intracranial Hemorrhage, Traumatic; Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Vascular Diseases; Cardiovascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematoma; Hemorrhage; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Omar Tanweer, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Omar Tanweer, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Cerebrovascular and Endovascular Neurosurgery

Study Record Dates

• First Submitted: December 2, 2024
• First Posted: December 5, 2024
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2029
• Study Completion (Estimated): October 1, 2030
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share