Chronic Subdural HematomaNCT04065113
Middle Meningeal Artery Embolization for Chronic Subdural Hematoma
An observational study of Chronic Subdural Hematoma, run by Washington University School of Medicine at 1 site in United States.
Trial summary
Endovascular middle meningeal artery (MMA) embolization is an emerging treatment for chronic subdural hematoma (cSDH). There is preliminary data to suggest that this minimally invasive therapy may be more efficacious and equally as safe compared to conventional, more invasive surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Subdural Hematoma
- What is being tested?
- Middle Meningeal Artery Embolization with polyvinyl alcohol particles (PVA) and Drainage of Subdural Hematoma
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Sep 2019to 1 Jun 2025
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: number of participants reflects population with diagnosis
Who may be able to join
- Patients 18 years or older undergoing treatment for a new diagnosis of chronic subdural hematoma (cSDH) or
- Patients 18 year or older who have undergone surgical evacuation of a subdural hematoma and have a significant residual hematoma status post-surgery or who develop a recurrent subdural hematoma.
- and
- Minimal symptoms such as headache, altered mental status, or mild neurological deficit only
- Ability to understand and sign written informed consent by patient or LAR
Who cannot join
- Significant midline shift and/or neurologic symptoms requiring urgent decompression.
- Common carotid stenosis of over 50%.
- Significant contraindication to angiography (eg. kidney failure, difficult anatomy).
- SDH related to underlying condition
- Acute SDH
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63108
About this study
Official title: Middle Meningeal Artery (MMA) Embolization for Patients With Chronic Subdural Hematoma (cSDH)
Endovascular middle meningeal artery (MMA) embolization is an emerging treatment for chronic subdural hematoma (cSDH). There is preliminary data to suggest that this minimally invasive therapy may be more efficacious and equally as safe compared to conventional, more invasive surgery. This study seeks to assess the safety and efficacy of middle meningeal artery embolization for chronic subdural hematoma as an adjunct to standard treatments, which include medical management and surgical evacuation.
Read the detailed description
This study seeks to assess the safety and efficacy of middle meningeal artery embolization for chronic subdural hematoma in addition to standard treatments, which include close observation and surgical evacuation. Middle meningeal artery embolization has emerged recently as a minimally invasive and successful method of preventing re-accumulation of subdural hematoma, particularly for patients that are not obvious surgical candidates or those with recurrent or refractory hematomas. The outcomes of these two groups of patients who undergo middle meningeal artery embolization will be compared to matched historical controls.
Middle meningeal artery embolization is a minimally invasive angiography procedure completed with use of fluoroscopy. Access is obtained through the femoral or radial artery and a catheter is advanced to the MMA. Polyvinyl alcohol particles are then injected to seal off this portion of the artery and prevent any further blood flow into the subdural hematoma. Hemostasis is obtained at the access site and the patient is observed for 24-48 hours on a neurological care unit before discharge.
A head CT, NIHSS, and modified Rankin Score will be repeated on the following schedule: • Pre-Procedure
- 24 hours post procedure
- 7-10 days post procedure
- 30 days post procedure
- 90 days post procedure
Patients with chronic subdural hematoma undergo CT scans and neurologic assessments on hospital admission, as well as follow up CT scans and neurologic assessments to assess for any change in neurologic status or hematoma size. This study utilizes a standard of care follow up schedule to avoid exposing participants to extra radiation. Participants will be followed for study related purposes for 90 days.
- Conditions
- Chronic Subdural Hematoma
- Being tested
- Middle Meningeal Artery Embolization with polyvinyl alcohol particles (PVA), Drainage of Subdural Hematoma
- 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.
Middle Meningeal Artery Embolization with polyvinyl alcohol particles (PVA)Procedure or surgery
Also called MMA Embolization with polyvinyl alcohol (PVA) particles
Seal off blood supply to the middle meningeal artery to prevent growth of subdural hematoma
Drainage of Subdural HematomaProcedure or surgery
Also called Burr Hole Drainage, Craniotomy
Drainage of subdural hematoma via burrhole or craniotomy
| Study group | Role | What they receive |
|---|---|---|
| Embolization Only | Medically managed patient receives middle meningeal artery embolization Receives: Procedure: Middle Meningeal Artery Embolization with polyvinyl alcohol particles (PVA) | |
| Embolization + Evacuation | Participant receives standard of care evacuation and then undergoes MMA embolization Receives: Procedure: Middle Meningeal Artery Embolization with polyvinyl alcohol particles (PVA); Procedure: Drainage of Subdural Hematoma | |
| Medical Management | Historical control of medically managed patients | |
| Surgical Patients | Historical control of patients receiving standard surgery alone Receives: Procedure: Drainage of Subdural Hematoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with recurrent or refractory hematoma (Radiographic resolution)
The subdural hematoma persists or reoccurs
Measured: A head CT will be repeated 24 hours after the procedure, 7-10 days, 30 days, and 90 days post procedure to measure any change in size of the SDH compared to pre-procedure size
Number of patients requiring secondary evacuation surgery (Treatment Efficacy)
The participant requires a post-procedure (post-MMA embolization) evacuation of the subdural hematoma due to re-occurrence or persistence of hematoma and symptoms
Measured: Evacuation surgery required within the 90 day follow up period
Secondary outcomes (4)
Procedure-related complication rate (Safety)
Complication rate of embolization procedure vs surgery
Measured: Procedure-related complications will be compared between embolization and historical surgical patients assessed through study completion, 90 days
Change in NIH Stroke Scale Score (Functional outcome)
Change in score on National Institutes of Health Stroke Scale. The NIH Stroke Scale is used to quantify neurologic impairments. It consists of 11 items each scored between 0 and 4 points. The maximum score is 42, indicating severe impairment, and the minimum score is 0.
Stroke severity 0 No stroke symptoms 1-4 Minor stroke 5-15 Moderate stroke 16-20 Moderate to severe stroke 21-42 Severe stroke
Measured: Compared pre-procedure, 24 hours post-procedure, 7-10 days, 30 days, and 90 days post-procedure
Change in modified Rankin Scale (Functional outcome)
Change in score on modified Rankin Scale
The modified Rankin Scale (mRS) measures the degree of disability or dependence after a stroke or other neurologic disease.
The scale runs from 0-6, with 0 indicating perfect health with no symptoms to 6 indicating death.
0 - No symptoms.
- - No significant disability. Able to carry out all usual activities, despite some symptoms.
- - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
- - Moderate disability. Requires some help, but able to walk unassisted.
- - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
- - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
- - Dead.
Measured: Compared pre-procedure, 24 hours post-procedure, 7-10 days, 30 days, and 90 days post-procedure
Change in size of subdural hematoma
CT scan measurements of size of subdural hematoma
Measured: Compared pre-procedure, 24 hours post-procedure, 7-10 days, 30 days, and 90 days post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2019
- Study start19 Sep 2019
- Primary completion1 Aug 2024
- Study completion1 Jun 2025
Why it stopped: due to reason 3 in the protocol- any new information becomes available during the trial that necessitates stopping the trial. New information became available with device no longer being investigational.
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 Washington University School 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joshua W Osbun, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04065113
- Sponsor's protocol ID
- 201905146
- Status last verified
- Jul 2025
- First submitted
- 15 Aug 2019
- Last updated
- 22 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Middle Meningeal Artery (MMA) Embolization for Patients With Chronic Subdural Hematoma (cSDH)
- ClinicalTrials.gov ID
- NCT04065113
- Acronym / sponsor ID
- 201905146
- Conditions
- Chronic Subdural Hematoma
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: due to reason 3 in the protocol- any new information becomes available during the trial that necessitates stopping the trial. New information became available with device no longer being investigational.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 19 Sep 2019 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 22 Aug 2019 (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.
Endovascular middle meningeal artery (MMA) embolization is an emerging treatment for chronic subdural hematoma (cSDH). There is preliminary data to suggest that this minimally invasive therapy may be more efficacious and equally as safe compared to conventional, more invasive surgery. This study seeks to assess the safety and efficacy of middle meningeal artery embolization for chronic subdural hematoma as an adjunct to standard treatments, which include medical management and surgical evacuation.
Detailed description
This study seeks to assess the safety and efficacy of middle meningeal artery embolization for chronic subdural hematoma in addition to standard treatments, which include close observation and surgical evacuation. Middle meningeal artery embolization has emerged recently as a minimally invasive and successful method of preventing re-accumulation of subdural hematoma, particularly for patients that are not obvious surgical candidates or those with recurrent or refractory hematomas. The outcomes of these two groups of patients who undergo middle meningeal artery embolization will be compared to matched historical controls.
Middle meningeal artery embolization is a minimally invasive angiography procedure completed with use of fluoroscopy. Access is obtained through the femoral or radial artery and a catheter is advanced to the MMA. Polyvinyl alcohol particles are then injected to seal off this portion of the artery and prevent any further blood flow into the subdural hematoma. Hemostasis is obtained at the access site and the patient is observed for 24-48 hours on a neurological care unit before discharge.
A head CT, NIHSS, and modified Rankin Score will be repeated on the following schedule: • Pre-Procedure
- 24 hours post procedure
- 7-10 days post procedure
- 30 days post procedure
- 90 days post procedure
Patients with chronic subdural hematoma undergo CT scans and neurologic assessments on hospital admission, as well as follow up CT scans and neurologic assessments to assess for any change in neurologic status or hematoma size. This study utilizes a standard of care follow up schedule to avoid exposing participants to extra radiation. Participants will be followed for study related purposes for 90 days.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Embolization Only | – | Procedure: Middle Meningeal Artery Embolization with polyvinyl alcohol particles (PVA)Medically managed patient receives middle meningeal artery embolization |
| Embolization + Evacuation | – | Procedure: Middle Meningeal Artery Embolization with polyvinyl alcohol particles (PVA), Procedure: Drainage of Subdural HematomaParticipant receives standard of care evacuation and then undergoes MMA embolization |
| Medical Management | – | –Historical control of medically managed patients |
| Surgical Patients | – | Procedure: Drainage of Subdural HematomaHistorical control of patients receiving standard surgery alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- number of participants reflects population with diagnosis
Key inclusion criteria (5 listed)
- Patients 18 years or older undergoing treatment for a new diagnosis of chronic subdural hematoma (cSDH) or
- Patients 18 year or older who have undergone surgical evacuation of a subdural hematoma and have a significant residual hematoma status post-surgery or who develop a recurrent subdural hematoma.
- and
- Minimal symptoms such as headache, altered mental status, or mild neurological deficit only
- Ability to understand and sign written informed consent by patient or LAR
Key exclusion criteria (5 listed)
- Significant midline shift and/or neurologic symptoms requiring urgent decompression.
- Common carotid stenosis of over 50%.
- Significant contraindication to angiography (eg. kidney failure, difficult anatomy).
- SDH related to underlying condition
- Acute SDH
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 |
|---|---|---|
| Middle Meningeal Artery Embolization with polyvinyl alcohol particles (PVA)Also: MMA Embolization with polyvinyl alcohol (PVA) particlesSeal off blood supply to the middle meningeal artery to prevent growth of subdural hematoma | Procedure or surgery | Embolization + Evacuation, Embolization Only |
| Drainage of Subdural HematomaAlso: Burr Hole Drainage, CraniotomyDrainage of subdural hematoma via burrhole or craniotomy | Procedure or surgery | Embolization + Evacuation, Surgical Patients |
Primary outcome
Number of patients with recurrent or refractory hematoma (Radiographic resolution)
Time frame: A head CT will be repeated 24 hours after the procedure, 7-10 days, 30 days, and 90 days post procedure to measure any change in size of the SDH compared to pre-procedure size
The subdural hematoma persists or reoccurs
Number of patients requiring secondary evacuation surgery (Treatment Efficacy)
Time frame: Evacuation surgery required within the 90 day follow up period
The participant requires a post-procedure (post-MMA embolization) evacuation of the subdural hematoma due to re-occurrence or persistence of hematoma and symptoms
4 secondary outcomes
Procedure-related complication rate (Safety)
Time frame: Procedure-related complications will be compared between embolization and historical surgical patients assessed through study completion, 90 days
Change in NIH Stroke Scale Score (Functional outcome)
Time frame: Compared pre-procedure, 24 hours post-procedure, 7-10 days, 30 days, and 90 days post-procedure
Change in modified Rankin Scale (Functional outcome)
Time frame: Compared pre-procedure, 24 hours post-procedure, 7-10 days, 30 days, and 90 days post-procedure
Change in size of subdural hematoma
Time frame: Compared pre-procedure, 24 hours post-procedure, 7-10 days, 30 days, and 90 days post-procedure
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 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. This study is not recruiting at the moment.
Joshua W Osbun, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Subdural Hematoma, run by Washington University School of Medicine at 1 site in United States.
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 5 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: withdrawn, as of the sponsor's last update on 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with recurrent or refractory hematoma (Radiographic resolution) (time frame: A head CT will be repeated 24 hours after the procedure, 7-10 days, 30 days, and 90 days post procedure to measure any change in size of the SDH compared to pre-procedure size). The study lists 2 primary outcomes in all. 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 22 Jul 2025.