A Phase 2 interventional study of Tranexamic Acid 650 MG and Placebo in Chronic Subdural Hematoma, sponsored by Baylor College of Medicine. Not yet recruiting. Open to participants aged 21 Years to 95 Years. Per ClinicalTrials.gov, last updated 2025-05-14.
Sponsored by Baylor College of Medicine · Phase 2, Interventional, and Treatment
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.
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.
112 studies on the registry are indexed under Hematoma, Subdural, Chronic; 49 are open to participants now.
This study's planned enrollment of 240 is above the median of 185 across 86 interventional studies indexed under Hematoma, Subdural, Chronic.
Browse Hematoma, Subdural, Chronic studies →Baylor College of Medicine is the lead sponsor of 747 studies on the registry; 110 are open to participants now.
Of its 84 completed or terminated interventional studies of FDA-regulated products, 45 (54%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
650mg tablets of TXA will be prescribed to be taken orally, once daily for 21 weeks.
Drug: Tranexamic Acid 650 MG
650mg placebo tablet will be prescribed to be taken orally, once daily for 21 weeks.
Drug: Placebo
PO administration of TXA tablet
PO administration of placebo tablet
Rate of resolution measured as the cSDH volume or diameter
Time frame: 6 weeks, 12 weeks, 21 weeks
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
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
Time frame: 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.
Time frame: 6 weeks, 12 weeks, 21 weeks
Occurrence of adverse events
Time frame: 6 weeks, 12 weeks, 21 weeks
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Oct 2025; primary completion for Oct 2029, 48 months later.
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This study is not yet recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tranexamic Acid