Chronic Subdural HematomaNCT04095819
Middle Meningeal Artery (MMA) Embolization Compared to Traditional Surgical Strategies to Treat Chronic Subdural Hematomas (cSDH)
A study testing Middle Meningeal Artery procedure and Traditional Surgery in people with Chronic Subdural Hematoma, run by Atlantic Health System at 1 site in United States.
Trial summary
Chronic Subdural Hematoma (cSDH) is a common hematologic problem particularly in older patients. The purpose of this study is to evaluate the safety and efficacy of middle meningeal artery (MMA) embolization compared to traditional surgical strategies for patients presenting with chronic subdural hematoma (cSDH). 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 procedure and Traditional Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jun 2019to 19 Apr 2022
- Phase
- Interventional
- 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
Who may be able to join
- Age 18 or older
- Participant or Surrogate must be English speaking
- Subjects must have a diagnosis of chronic or acute-on subdural hematoma based on brain imaging, as documented by an
- One or more symptoms attributable to chronic SDH including headache cognitive impairment, gait instability, seizure, or mild focal neurologic deficit.
- In opinion of Investigator or the subject's referring physician, the subject has failed conservative management.
Who cannot join
- The Subdural hematoma is causing mass effect significant enough to cause marked or progressive neurologic impairment
- Any requirement for urgent surgical evacuation is necessary
- Life expectancy is less than 6 months in the opinion of the subject's primary physician
- Markedly tortuous vasculature precluding safe endovascular access, as assessed on angiogram
- Acute subdural hematomas
- Health insurance doesn't cover MMA embolization or performing Surgeon and follow up visits are considered out of network.
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Overlook Medical Center
Summit, New Jersey, 07901
Ron Benitez, MD, 973-285-7800, rebenitez@ansdocs.com
Elena Lobur, RN, 908-522-2045, elena.lobur@atlantichealth.org
About this study
Official title: Pilot Study to Evaluate Safety of and Efficacy of Middle Meningeal Artery (MMA) Embolization Compared to Traditional Surgical Strategies to Treat Chronic Subdural Hematomas (cSDH)
Chronic Subdural Hematoma (cSDH) is a common hematologic problem particularly in older patients. The purpose of this study is to evaluate the safety and efficacy of middle meningeal artery (MMA) embolization compared to traditional surgical strategies for patients presenting with chronic subdural hematoma (cSDH). Although MMA embolization is minimally-invasive procedure that is routinely used for the treatment of tumors or vascular formations (1), this study investigates the use of an established procedure for a new disease state.
Read the detailed description
The purpose of the research study is to evaluate the safety and efficacy of a new, less-invasive procedure to treat chronic subdural hematoma (cSDH). A subdural hematoma occurs when blood collects on the brain's surface beneath the skull. Subdural hematomas can be life-threatening. They usually result from a head injury. This study will compare the new procedure to conventional surgical treatment of chronic subdural hematoma (cSDH). The new procedure is called middle meningeal artery embolization (MMA).
Current or conventional treatment of chronic subdural hematoma (cSDH) involves surgery (burr hole drainage and craniotomy) to access and remove the cause of the bleeding that is causing the subdural hematoma.
The new procedure, MMA embolization, involves guiding a catheter that is inserted into a blood vessel to the area of the brain that is supplying blood to the subdural hematoma. Particles or a special type of glue will be released to stop the bleeding that is causing the subdural hematoma. This technique has been used to treat other brain conditions, for example, (to treat tumors or malformation of blood vessels).
- Conditions
- Chronic Subdural Hematoma
- Being tested
- Middle Meningeal Artery procedure, Traditional Surgery
- 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 procedureProcedure or surgery
Seal off the blood supply to the middle meningeal artery to prevent growth of the Subdural Hematoma
Traditional SurgeryProcedure or surgery
Drainage of Subdural Hematoma using Craniotomy or Burr Hole
| Study group | Role | What they receive |
|---|---|---|
| Middle Meningeal Artery Embolization | Experimental | Middle Meningeal Artery Embolization Receives: Procedure: Middle Meningeal Artery procedure |
| Traditional Surgery | Active comparator | Craniotomy/Burr hole Receives: Procedure: Traditional Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in size of SDH
Changes in size of SDH will be recorded in maximum diameter within 6 months.
Measured: 6 months
Secondary outcomes (1)
Change in Neurological status
Changes in Neurological status after the procedure and through study completion
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2019
- Study start19 Jun 2019
- Primary completion19 Apr 2022 (estimated)
- Study completion19 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Subdural HematomaStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Atlantic Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ronald Benitez, MD, Atlantic Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04095819
- Sponsor's protocol ID
- AtlanticHS
- Status last verified
- Sep 2019
- First submitted
- 9 Sep 2019
- Last updated
- 19 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fuentes AM, Khalid SI, Mehta AI. Predictors of Subsequent Intervention After Middle Meningeal Artery Embolization for Treatment of Subdural Hematoma: A Nationwide Analysis. Neurosurgery. 2023 Jan 1;92(1):144-149. doi: 10.1227/neu.0000000000002151. Epub 2022 Sep 21.
PubMed 36129273
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Evaluate Safety of and Efficacy of Middle Meningeal Artery (MMA) Embolization Compared to Traditional Surgical Strategies to Treat Chronic Subdural Hematomas (cSDH)
- ClinicalTrials.gov ID
- NCT04095819
- Acronym / sponsor ID
- AtlanticHS
- Conditions
- Chronic Subdural Hematoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Atlantic Health SystemUniversity, hospital or other
- Study start
- 19 Jun 2019 (actual)
- Primary completion
- 19 Apr 2022 (estimated)
- Study completion
- 19 Apr 2022 (estimated)
- First posted
- 19 Sep 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.
Chronic Subdural Hematoma (cSDH) is a common hematologic problem particularly in older patients. The purpose of this study is to evaluate the safety and efficacy of middle meningeal artery (MMA) embolization compared to traditional surgical strategies for patients presenting with chronic subdural hematoma (cSDH). Although MMA embolization is minimally-invasive procedure that is routinely used for the treatment of tumors or vascular formations (1), this study investigates the use of an established procedure for a new disease state.
Detailed description
The purpose of the research study is to evaluate the safety and efficacy of a new, less-invasive procedure to treat chronic subdural hematoma (cSDH). A subdural hematoma occurs when blood collects on the brain's surface beneath the skull. Subdural hematomas can be life-threatening. They usually result from a head injury. This study will compare the new procedure to conventional surgical treatment of chronic subdural hematoma (cSDH). The new procedure is called middle meningeal artery embolization (MMA).
Current or conventional treatment of chronic subdural hematoma (cSDH) involves surgery (burr hole drainage and craniotomy) to access and remove the cause of the bleeding that is causing the subdural hematoma.
The new procedure, MMA embolization, involves guiding a catheter that is inserted into a blood vessel to the area of the brain that is supplying blood to the subdural hematoma. Particles or a special type of glue will be released to stop the bleeding that is causing the subdural hematoma. This technique has been used to treat other brain conditions, for example, (to treat tumors or malformation of blood vessels).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Middle Meningeal Artery Embolization | Experimental | Procedure: Middle Meningeal Artery procedureMiddle Meningeal Artery Embolization |
| Traditional Surgery | Active comparator | Procedure: Traditional SurgeryCraniotomy/Burr hole |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 or older
- Participant or Surrogate must be English speaking
- Subjects must have a diagnosis of chronic or acute-on subdural hematoma based on brain imaging, as documented by an
- One or more symptoms attributable to chronic SDH including headache cognitive impairment, gait instability, seizure, or mild focal neurologic deficit.
- In opinion of Investigator or the subject's referring physician, the subject has failed conservative management.
Key exclusion criteria (7 listed)
- The Subdural hematoma is causing mass effect significant enough to cause marked or progressive neurologic impairment
- Any requirement for urgent surgical evacuation is necessary
- Life expectancy is less than 6 months in the opinion of the subject's primary physician
- Markedly tortuous vasculature precluding safe endovascular access, as assessed on angiogram
- Acute subdural hematomas
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 procedureSeal off the blood supply to the middle meningeal artery to prevent growth of the Subdural Hematoma | Procedure or surgery | Middle Meningeal Artery Embolization |
| Traditional SurgeryDrainage of Subdural Hematoma using Craniotomy or Burr Hole | Procedure or surgery | Traditional Surgery |
Primary outcome
Change in size of SDH
Time frame: 6 months
Changes in size of SDH will be recorded in maximum diameter within 6 months.
1 secondary outcome
Change in Neurological status
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2019.
- Derived from this study: PubMed 36129273Fuentes AM, Khalid SI, Mehta AI. Predictors of Subsequent Intervention After Middle Meningeal Artery Embolization for Treatment of Subdural Hematoma: A Nationwide Analysis. Neurosurgery. 2023 Jan 1;92(1):144-149. doi: 10.1227/neu.0000000000002151. Epub 2022 Sep 21.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Middle Meningeal Artery procedure and Traditional Surgery in people with Chronic Subdural Hematoma, run by Atlantic Health System 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 7 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: status not confirmed, as of the sponsor's last update on 19 Sep 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Benitez (973-285-7800, rbenitez@ansdocs.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in size of SDH (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04095819, which also lists 1 linked publication.
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 19 Sep 2019.