Chronic Subdural HematomaPhase 2NCT06718751
Tranexamic Acid Therapy For The Treatment of Subdural Hematomas
A Phase 2 study testing Tranexamic Acid 650 MG in people with Chronic Subdural Hematoma, run by Baylor College of Medicine.
Trial 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). Read more about this study
- Who is it for?
- Ages 21 to 95 years
- Conditions the study is for
- Chronic Subdural Hematoma
- What is being tested?
- Tranexamic Acid 650 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- Oct 2025to Oct 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the detailed description
Patients must first be evaluated by a neurosurgeon and concluded to be managed conservatively, without a surgical procedure. Then patients may be enrolled into the study if they meet the specific inclusion and exclusion criteria mentioned above.
If the patient signs the informed consent and is enrolled into the study, the treating physician will inform the study team. The patient will be randomized into either treatment or placebo group per the above algorithm. The study will be double-blind, and only the statistician will know the patient groupings.
In the event that unblinding is needed, the statistician will inform the treating physician of the patient's study group.
Tranexamic acid (TXA), the study agent, or matching placebo will be prescribed as a 650mg tablet to be taken once daily for 21 weeks. The drug will be provided as an oral tablet from the pharmacy. The placebo will be a similar tablet. Once prescribed patients will follow the standard of care for conservative management of chronic subdural hematoma.
Baseline evaluation
After obtaining informed consent and prescription of study agent a baseline clinical examination will be done to assess patient's neurological status, including National Institute of Health Stroke Scale (NIHSS), Modified Rankin Score (mRS), and Glasgow Outcome Scale-Extended (GOSE) scales as well as record initial CT scans.
Week 6 follow-up
At the week 6 follow-up, patients will receive a head CT scan to evaluate for changes in hematoma volume and evaluate for coagulopathies. Functional outcomes will also be assessed, including NIHSS, mRS, and GOSE scales.
Week 12 follow-up
At the week 12 follow-up, patients will receive a head CT scan to evaluate for changes in hematoma volume, evaluate for coagulopathies, and hematoma recurrence. Functional outcomes will also be assessed, including NIHSS, mRS, and GOSE scales.
Week 21 follow-up
At the final week 21 follow-up, patients will receive a head CT scan to evaluate for changes in hematoma volume and recurrence. Functional outcomes will also be assessed, including NIHSS, mRS, and GOSE scales.
Standard of care consists of closely monitoring for new neurological symptoms, including altered mental status, focal neurological deficit, headache, or seizures, during hospital admission and during follow-up visits. If new neurological symptoms arise or if existing neurological symptoms do not improve based on progressive or non-resolving hematoma, surgical treatment may be reconsidered. The head CT is part of the standard of care for patients with subdural hematomas. The addition of the study agent, TXA or placebo, is the investigational part of the protocol and not standard of care. Scans will be copied for blinded independent radiologic review, and functional outcomes will be performed by the study physicians.
- Conditions
- Chronic Subdural Hematoma
- Being tested
- Tranexamic Acid 650 MG, Placebo
- Keywords
- tranexamic acid
- Medical subject headings
- Hematoma, Subdural, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic Acid 650 MGDrug
PO administration of TXA tablet
PlaceboDrug
PO administration of placebo tablet
| Study group | Role | What they receive |
|---|---|---|
| PO 650mg TXA tablet | Experimental | 650mg tablets of TXA will be prescribed to be taken orally, once daily for 21 weeks. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of resolution measured as the cSDH volume or diameter
Measured: 6 weeks, 12 weeks, 21 weeks
Secondary outcomes (7)
cSDH volume (measured as volume or diameter on follow-up CT scan of the head)
Measured: 6 weeks, 12 weeks, 21 weeks
Proportion of patients needing surgery
Measured: 12 weeks, 12 weeks, 21 weeks
Hematoma recurrence Hematoma recurrence
Measured: 12 weeks, 12 weeks, 21 weeks
Neurological outcome assessed by NIHSS
Measured: 6 weeks, 12 weeks, 21 weeks
Functional outcome assessed by mRS
mRS score is used to assess the degree of disability or dependence in the daily activities of people who have suffered a stroke or other neurological disability
Measured: 6 weeks, 12 weeks, 21 weeks
Functional outcome assessed by GOSE
Glasgow outcome scale extended is a a global scale for functional outcome that rates patient status into one of five categories: Dead, Vegetative State, Severe Disability, Moderate Disability or Good Recovery.
Measured: 6 weeks, 12 weeks, 21 weeks
Occurrence of adverse events
Measured: 6 weeks, 12 weeks, 21 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study startOct 2025 (estimated)
- Primary completionOct 2029 (estimated)
- Study completionOct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Subdural HematomaStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Tanweer, Baylor College of Medicine
- Investigators
- Omar Tanweer, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06718751
- Sponsor's protocol ID
- H-55608
- Status last verified
- May 2025
- First submitted
- 2 Dec 2024
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tranexamic Acid Therapy For The Treatment of Subdural Hematomas
- ClinicalTrials.gov ID
- NCT06718751
- Acronym / sponsor ID
- H-55608
- Conditions
- Chronic Subdural Hematoma
- Keywords
- tranexamic acid
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- Oct 2025 (estimated)
- Primary completion
- Oct 2029 (estimated)
- Study completion
- Oct 2030 (estimated)
- First posted
- 5 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients must first be evaluated by a neurosurgeon and concluded to be managed conservatively, without a surgical procedure. Then patients may be enrolled into the study if they meet the specific inclusion and exclusion criteria mentioned above.
If the patient signs the informed consent and is enrolled into the study, the treating physician will inform the study team. The patient will be randomized into either treatment or placebo group per the above algorithm. The study will be double-blind, and only the statistician will know the patient groupings.
In the event that unblinding is needed, the statistician will inform the treating physician of the patient's study group.
Tranexamic acid (TXA), the study agent, or matching placebo will be prescribed as a 650mg tablet to be taken once daily for 21 weeks. The drug will be provided as an oral tablet from the pharmacy. The placebo will be a similar tablet. Once prescribed patients will follow the standard of care for conservative management of chronic subdural hematoma.
Baseline evaluation
After obtaining informed consent and prescription of study agent a baseline clinical examination will be done to assess patient's neurological status, including National Institute of Health Stroke Scale (NIHSS), Modified Rankin Score (mRS), and Glasgow Outcome Scale-Extended (GOSE) scales as well as record initial CT scans.
Week 6 follow-up
At the week 6 follow-up, patients will receive a head CT scan to evaluate for changes in hematoma volume and evaluate for coagulopathies. Functional outcomes will also be assessed, including NIHSS, mRS, and GOSE scales.
Week 12 follow-up
At the week 12 follow-up, patients will receive a head CT scan to evaluate for changes in hematoma volume, evaluate for coagulopathies, and hematoma recurrence. Functional outcomes will also be assessed, including NIHSS, mRS, and GOSE scales.
Week 21 follow-up
At the final week 21 follow-up, patients will receive a head CT scan to evaluate for changes in hematoma volume and recurrence. Functional outcomes will also be assessed, including NIHSS, mRS, and GOSE scales.
Standard of care consists of closely monitoring for new neurological symptoms, including altered mental status, focal neurological deficit, headache, or seizures, during hospital admission and during follow-up visits. If new neurological symptoms arise or if existing neurological symptoms do not improve based on progressive or non-resolving hematoma, surgical treatment may be reconsidered. The head CT is part of the standard of care for patients with subdural hematomas. The addition of the study agent, TXA or placebo, is the investigational part of the protocol and not standard of care. Scans will be copied for blinded independent radiologic review, and functional outcomes will be performed by the study physicians.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PO 650mg TXA tablet | Experimental | Drug: Tranexamic Acid 650 MG650mg tablets of TXA will be prescribed to be taken orally, once daily for 21 weeks. |
| PO 650mg placebo tablet | Placebo comparator | Drug: Placebo650mg placebo tablet will be prescribed to be taken orally, once daily for 21 weeks. |
Who may qualify
- Ages
- 21 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tranexamic Acid 650 MGPO administration of TXA tablet | Drug | PO 650mg TXA tablet |
| PlaceboPO administration of placebo tablet | Drug | PO 650mg placebo tablet |
Primary outcome
Rate of resolution measured as the cSDH volume or diameter
Time frame: 6 weeks, 12 weeks, 21 weeks
7 secondary outcomes
cSDH volume (measured as volume or diameter on follow-up CT scan of the head)
Time frame: 6 weeks, 12 weeks, 21 weeks
Proportion of patients needing surgery
Time frame: 12 weeks, 12 weeks, 21 weeks
Hematoma recurrence Hematoma recurrence
Time frame: 12 weeks, 12 weeks, 21 weeks
Neurological outcome assessed by NIHSS
Time frame: 6 weeks, 12 weeks, 21 weeks
Functional outcome assessed by mRS
Time frame: 6 weeks, 12 weeks, 21 weeks
Functional outcome assessed by GOSE
Time frame: 6 weeks, 12 weeks, 21 weeks
Occurrence of adverse events
Time frame: 6 weeks, 12 weeks, 21 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Omar Tanweer, MD principal investigator
Baylor College of Medicine
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tranexamic Acid 650 MG in people with Chronic Subdural Hematoma, run by Baylor College of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Omar Tanweer, MD ((713)-798-4696, omar.tanweer@bcm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of resolution measured as the cSDH volume or diameter (time frame: 6 weeks, 12 weeks, 21 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2025.