Tranexamic Acid Therapy For The Treatment of Subdural Hematomas

May 12, 2025 updated by: Omar Tanweer, Baylor College of Medicine
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
240

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: PO 650mg TXA tablet
650mg tablets of TXA will be prescribed to be taken orally, once daily for 21 weeks.
Drug: Tranexamic Acid 650 MG
PO administration of TXA tablet
Placebo Comparator: PO 650mg placebo tablet
650mg placebo tablet will be prescribed to be taken orally, once daily for 21 weeks.
Drug: Placebo
PO administration of placebo tablet

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Rate of resolution measured as the cSDH volume or diameter
Time Frame: 6 weeks, 12 weeks, 21 weeks
6 weeks, 12 weeks, 21 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
cSDH volume (measured as volume or diameter on follow-up CT scan of the head)
Time Frame: 6 weeks, 12 weeks, 21 weeks
6 weeks, 12 weeks, 21 weeks
Proportion of patients needing surgery
Time Frame: 12 weeks, 12 weeks, 21 weeks
12 weeks, 12 weeks, 21 weeks
Hematoma recurrence Hematoma recurrence
Time Frame: 12 weeks, 12 weeks, 21 weeks
12 weeks, 12 weeks, 21 weeks
Neurological outcome assessed by NIHSS
Time Frame: 6 weeks, 12 weeks, 21 weeks
6 weeks, 12 weeks, 21 weeks
Functional outcome assessed by mRS
Time Frame: 6 weeks, 12 weeks, 21 weeks
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
6 weeks, 12 weeks, 21 weeks
Functional outcome assessed by GOSE
Time Frame: 6 weeks, 12 weeks, 21 weeks
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.
6 weeks, 12 weeks, 21 weeks
Occurrence of adverse events
Time Frame: 6 weeks, 12 weeks, 21 weeks
6 weeks, 12 weeks, 21 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Baylor College of Medicine

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Omar Tanweer, MD, Baylor College of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 2, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 2, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 5, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 14, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H-55608

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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