Chronic Subdural HematomaMESHNCT06181994
Middle Meningeal Artery Embolization (MMAE) Outcomes for Chronic Subdural Hematoma (cSDH)
An observational study of Chronic Subdural Hematoma, run by Montefiore Medical Center at 22 sites in 3 countries.
Trial summary
This multi-center retrospective cohort study aims to investigate the real-world outcomes of chronic subdural hematoma treated with MMAE, including clinical effectiveness, recurrence rates, and safety profile. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Subdural Hematoma
- How many people
- 5,000 participants
- Where
- 22 sitesin 3 countries
- Study dates
- 5 Dec 2023to Dec 2026
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chronic subdural hematoma
Who may be able to join
- Consecutive adult patients (18 yrs. of age or older)
- Endovascular embolization of middle meningeal artery using any embolization material:
- PVA particles; Onyx, N-butyl cyanoacrylate (nBCA) glue; dimethyl sulfoxide, microcoils, polyvinyl alcohol (PVA) with microcoils
Who cannot join
- Endovascular embolization of middle meningeal artery using any other embolization material
Trial locations and contacts
22 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
22 sites in 3 countries
United States18 sites, 11 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Aman Patel, MD, 617-643-5547, abpatel@mgh.harvard.edu
- Recruiting
Beth Israel Deaconess Medical Center (BIDMC)/Harvard Medical School
Boston, Massachusetts, 02215
Christopher S Ogilvy, MD, 617-632-7246, mrotondo@bidmc.harvard.edu
- Recruiting
Lahey Hospital and Medical Center
Burlington, Massachusetts, 01805
Timo Krings, MD, PhD, MSc, 781-744-3330, Timo.Krings@lahey.org
- Completed
University of Illinois Chicago
Chicago, Illinois, 60607
- Recruiting
University of Chicago Medicine
Chicago, Illinois, 60637
Tareq Kass-Hout, MD, 773-702-6222, tkasshout@bsd.uchicago.edu
- Recruiting
Baptist Health South Florida, Inc.
Coral Gables, Florida, 33143
Italo Linfante, MD, 786-596-1825, ItaloL@baptisthealth.net
- Completed
Geisinger Health
Danville, Pennsylvania, 17822
- Completed
UTHealth Houston
Houston, Texas, 77030
- Completed
The University of Iowa
Iowa City, Iowa, 52242
- Completed
Mayo Clinic Florida
Jacksonville, Florida, 32224
- Completed
HCA Houston Healthcare Kingwood
Kingwood, Texas, 77339
- Recruiting
University of Miami
Miami, Florida, 33136
Robert Starke, MD, 305-243-3254, rstarke@med.miami.edu
- Recruiting
Allina Health
Minneapolis, Minnesota, 55404
Collin M Torok, MD, 612-863-0376, collin.torok@allina.com
Marie Meyer, MA, marie.meyer@allina.com
- Recruiting
West Virginia University
Morgantown, West Virginia, 26506
Dhairya A Lakhani, MD, 304-293-9198, dhairya.lakhani@hsc.wvu.edu
Tyler McGaughey, PhD, tyler.mcgaughey@hsc.wvu.edu
- Recruiting
Orlando Regional Medical Center
Orlando, Florida, 32806
Paul Foreman, MD, 321-841-7550, paul.foreman@orlandohealth.com
- Recruiting
Thomas Jefferson University
Philadelphia, Pennsylvania, 19144
Pascal M Jabbour, MD, 215-955-7000, pascal.jabbour@jefferson.edu
- Completed
Mayo Clinic
Rochester, Minnesota, 55905
- Recruiting
Montefiore Medical Center
The Bronx, New York, 10467
Muhammed Amir Essibayi, MD, 347-908-1889, muhammedamir.essibayi@einsteinmed.edu
David Altschul, MD, 718-920-7498, daltschu@montefiore.org
Canada3 sites, 1 recruiting
- Completed
Unity Health Toronto
Toronto, Ontario, M5C 2T2
- Recruiting
University of Toronto
Toronto, Ontario, M5S 1A1
Pascal J Mosimann, MD, PD, 416-603-5800, pascal.mosimann@uhn.ca
- Completed
Toronto Western Hospital
Toronto, Ontario, M5T 2S8
Australia1 site, 1 recruiting
- Recruiting
Austin Health
Heidelberg, Victoria, 3084
Hamed Asadi, MD, +61 9496 6794, hamed.asadi@austin.org.au
About this study
Official title: Outcomes of Middle Meningeal Artery for Treatment of Chronic Subdural Hematoma; Middle Meningeal Artery Embolization for Chronic Subdural Hematoma (MESH)
This multi-center retrospective cohort study aims to investigate the real-world outcomes of chronic subdural hematoma treated with MMAE, including clinical effectiveness, recurrence rates, and safety profile.
Read the detailed description
Chronic subdural hematoma (cSDH) is a prevalent neurosurgical condition marked by the accumulation of blood in the subarachnoid space. Primarily affecting elderly individuals, cSDH is associated with significant morbidity and mortality rates. Current standard treatments for cSDH involve surgical evacuation through burr hole craniotomy or twist-drill craniotomy; however, recent research has illuminated the potential significance of the middle meningeal artery (MMA) in cSDH pathogenesis, suggesting an innovative minimally invasive treatment avenue. The investigator team is attempting to determine whether MMA embolization has demonstrated a favorable safety profile with a low incidence of treatment-related complications.
While traditional surgical interventions have demonstrated positive outcomes in cSDH management, inherent challenges such as perioperative complications, extended hospital stays, and the risk of recurrence persist. Given the emerging insights into cSDH's underlying mechanisms, targeting the MMA presents an intriguing therapeutic alternative. The MMA, which supplies the dura mater's outer layer, has been implicated in cSDH formation and progression due to its fragility and propensity to rupture. By embolization of the MMA (MMAE), the opportunity arises to potentially mitigate bleeding risk and reduce the likelihood of hematoma reaccumulation. Recent case reports and a significant number of retrospective studies have shown encouraging results with MMA embolization as an adjunct or alternative to conventional surgical methods. Nevertheless, most of the reported studies are case series with limited sample sizes. Moreover, a comprehensive assessment of outcomes, complications, and long-term efficacy necessitates well-structured retrospective studies. The findings of this study hold the potential to better understand the outcomes of MMAE for cSDH. This study aims to provide valuable insights that can guide clinical decision-making, potentially leading to improved patient outcomes and more efficient resource utilization,
The following collaborators are also involved in the research:
Hamza Adel Salim Email: HASalim@MDAnderson.org
Adam A Dmytriw MD MPH MSc Email: adam.dmytriw@gmail.com
Rahim Abo Kasem, MD Email: rahim.abokasem@louisville.edu
Name: Muhammed Amir Essibayi, MD Email: m.amir.essibayi@gmail.com
- Conditions
- Chronic Subdural Hematoma
- Keywords
- Middle meningeal artery embolization, Endovascular Embolization
- 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.
| Study group | Role | What they receive |
|---|---|---|
| MMA Embolization | Adults with chronic subdural hematoma who underwent endovascular embolization of the middle meningeal artery as part of routine clinical care, using any embolic material | |
| Surgical Evacuation | Adults with chronic subdural hematoma who underwent surgical drainage of the hematoma as part of routine clinical care. | |
| Observation only | Adults with chronic subdural hematoma who were managed with clinical and imaging monitoring, without embolization or surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reaccumulation of Hematoma
The percentage of patients who were determined to have a reaccumulation of their hematoma will be tabulated and reported
Measured: Within 1 month post MMAE
Rescue surgical evacuation
The percentage of patients who were determined to require rescue surgical evacuation of their hematoma will be tabulated and reported
Measured: Between 1-3 months post MMAE
Secondary outcomes (17)
Reaccumulation of Hematoma
The percentage of patients who were determined to have a reaccumulation of their hematoma will be tabulated and reported. Reaccumulation of the hematoma will be determined by measuring the hematoma thickness at a given time point and comparing it to the thickness measured at the previous time point.
Measured: Between 1-3 months post MMAE
Reaccumulation of Hematoma
The percentage of patients who were determined to have a reaccumulation of their hematoma will be tabulated and reported. Reaccumulation of the hematoma will be determined by measuring the hematoma thickness at a given time point and comparing it to the thickness measured at the previous time point.
Measured: Between 3-6 months post MMAE
Reaccumulation of Hematoma
The percentage of patients who were determined to have a reaccumulation of their hematoma will be tabulated and reported. Reaccumulation of the hematoma will be determined by measuring the hematoma thickness at a given time point and comparing it to the thickness measured at the previous time point.
Measured: Between 6-12 months post MMAE
Reaccumulation of Hematoma
The percentage of patients who were determined to have a reaccumulation of their hematoma will be tabulated and reported. Reaccumulation of the hematoma will be determined by measuring the hematoma thickness at a given time point and comparing it to the thickness measured at the previous time point.
Measured: Between 12-24 months post MMAE
Clinical Outcome at Follow-up Clinical outcome at follow-up
Clinical outcome at follow-up will be assessed using a variant of the modified Rankin Scale (mRS) for neurologic disability. The classic mRS is a 6-point disability scale with possible scores ranging from 0-5. mRS measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. Higher scores are generally associated with less favorable outcomes. For this study patients with an mRS score of 0-2 will be determined to have had a "favorable" outcome to the procedure and patients with an mRS score of 3-5 will have been determined to have had an "unfavorable" outcome. Scoring will also include a 6 to identify patients who have expired.
Measured: Upon study discharge, 1-4 weeks
Clinical Outcome at Follow-up Clinical outcome at follow-up
Clinical outcome at follow-up will be assessed using a variant of the modified Rankin Scale (mRS) for neurologic disability. The classic mRS is a 6-point disability scale with possible scores ranging from 0-5. mRS measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. Higher scores are generally associated with less favorable outcomes. For this study patients with an mRS score of 0-2 will be determined to have had a "favorable" outcome to the procedure and patients with an mRS score of 3-5 will have been determined to have had an "unfavorable" outcome. Scoring will also include a 6 to identify patients who have expired.
Measured: Within 1 month post MMAE
Clinical Outcome at Follow-up Clinical outcome at follow-up
Clinical outcome at follow-up will be assessed using a variant of the modified Rankin Scale (mRS) for neurologic disability. The classic mRS is a 6-point disability scale with possible scores ranging from 0-5. mRS measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. Higher scores are generally associated with less favorable outcomes. For this study patients with an mRS score of 0-2 will be determined to have had a "favorable" outcome to the procedure and patients with an mRS score of 3-5 will have been determined to have had an "unfavorable" outcome. Scoring will also include a 6 to identify patients who have expired.
Measured: Between 1-3 months post MMAE
Clinical Outcome at Follow-up Clinical outcome at follow-up
Clinical outcome at follow-up will be assessed using a variant of the modified Rankin Scale (mRS) for neurologic disability. The classic mRS is a 6-point disability scale with possible scores ranging from 0-5. mRS measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. Higher scores are generally associated with less favorable outcomes. For this study patients with an mRS score of 0-2 will be determined to have had a "favorable" outcome to the procedure and patients with an mRS score of 3-5 will have been determined to have had an "unfavorable" outcome. Scoring will also include a 6 to identify patients who have expired.
Measured: Between 3-6 months post MMAE
Clinical Outcome at Follow-up Clinical outcome at follow-up
Clinical outcome at follow-up will be assessed using a variant of the modified Rankin Scale (mRS) for neurologic disability. The classic mRS is a 6-point disability scale with possible scores ranging from 0-5. mRS measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. Higher scores are generally associated with less favorable outcomes. For this study patients with an mRS score of 0-2 will be determined to have had a "favorable" outcome to the procedure and patients with an mRS score of 3-5 will have been determined to have had an "unfavorable" outcome. Scoring will also include a 6 to identify patients who have expired.
Measured: Between 6-12 months post MMAE
Clinical Outcome at Follow-up Clinical outcome at follow-up
Clinical outcome at follow-up will be assessed using a variant of the modified Rankin Scale (mRS) for neurologic disability. The classic mRS is a 6-point disability scale with possible scores ranging from 0-5. mRS measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. Higher scores are generally associated with less favorable outcomes. For this study patients with an mRS score of 0-2 will be determined to have had a "favorable" outcome to the procedure and patients with an mRS score of 3-5 will have been determined to have had an "unfavorable" outcome. Scoring will also include a 6 to identify patients who have expired.
Measured: Between 12-24 months post MMAE
Complications following MMAE
Complications following MMAE will be identified and tabulated as either permanent or transient in nature
Measured: Following the procedure, up to 4 weeks
Timing of Complications
Complications will be categorized and tabulated as having occurred perioperatively or postoperatively
Measured: Following the procedure, up to 4 weeks
Relatedness of Complications
Complications will be assessed as to whether or not they were related to the surgical procedure
Measured: Following the procedure, up to 4 weeks
Duration of Hospital Stay
The median duration of hospital stay will be tabulated and reported
Measured: Upon study discharge, up to 24 months
Clinical outcome at discharge
Clinical outcome at discharge will be assessed using the modified Rankin Scale (mRS) for neurologic disability. The mRS being used is a 7-point scale with possible scores ranging from 0-6. mRS measures the degree of disability or dependence in the daily activities of people who have suffered neurological disability. Scoring ranges from 0 (no residual symptoms) to 5 (severe neurologic disability). A patient who has expired (during or after discharge from hospital) is assigned a score of 6. Scores will be averaged and reported. Higher mRS scores are associated with progressively less favorable outcomes.
Measured: Upon study discharge, up to 24 months
Disposition After Discharge
Disposition upon discharge will be categorized as either discharged to home; discharged to home with health service, discharged to rehabilitation facility, or death
Measured: Upon study discharge, up to 24 months
Rescue surgical evacuation
The percentage of patients who were determined to require rescue surgical evacuation of their hematoma will be tabulated and reported
Measured: Between 3-12 months post MMAE
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2023
- Study start5 Dec 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Chronic Subdural HematomaStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe 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
- Retrospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Geisinger Clinic, Heidelberg University, Henri Mondor University Hospital, Ospedale Policlinico San Martino, Ospedale San Raffaele, Lehigh Valley Hospital, Mayo Clinic, Medical University of South Carolina, New York University, Oregon Health and Science University, Sisters of Mercy University Hospital, Unity Health Toronto, Sutter Health, University of Iowa, Thomas Jefferson University, University Health Network, Toronto, University Hospital, Bordeaux, University of Alabama at Birmingham, University of South Florida, University of Washington, Cornell University, Westchester Medical Center
- Responsible party
- Sponsor
- Investigators
- David Altschul, MD, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06181994
- Sponsor's protocol ID
- 2023-15327
- Other IDs
- 2023
- Acronym
- MESH
- Status last verified
- Sep 2026
- First submitted
- 5 Dec 2023
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Asghar M, Adhiyaman V, Greenway MW, Bhowmick BK, Bates A. Chronic subdural haematoma in the elderly--a North Wales experience. J R Soc Med. 2002 Jun;95(6):290-2. doi: 10.1258/jrsm.95.6.290.
PubMed 12042376Sahyouni R, Goshtasbi K, Mahmoodi A, Tran DK, Chen JW. Chronic Subdural Hematoma: A Historical and Clinical Perspective. World Neurosurg. 2017 Dec;108:948-953. doi: 10.1016/j.wneu.2017.09.064. Epub 2017 Sep 19.
PubMed 28935548Lee HS, Song SW, Chun YI, Choe WJ, Cho J, Moon CT, Koh YC. Complications Following Burr Hole Craniostomy and Closed-System Drainage for Subdural Lesions. Korean J Neurotrauma. 2018 Oct;14(2):68-75. doi: 10.13004/kjnt.2018.14.2.68. Epub 2018 Oct 31.
PubMed 30402421Shapiro M, Walker M, Carroll KT, Levitt MR, Raz E, Nossek E, Delavari N, Mir O, Nelson PK. Neuroanatomy of cranial dural vessels: implications for subdural hematoma embolization. J Neurointerv Surg. 2021 May;13(5):471-477. doi: 10.1136/neurintsurg-2020-016798. Epub 2021 Feb 25.
PubMed 33632880Akbik OS, Starling R, Green R, Zhu Y, Lewis J. Delayed Surgical Intervention in Acute Subdural Hematoma. Cureus. 2020 Nov 20;12(11):e11592. doi: 10.7759/cureus.11592.
PubMed 33364114Mondorf Y, Abu-Owaimer M, Gaab MR, Oertel JM. Chronic subdural hematoma--craniotomy versus burr hole trepanation. Br J Neurosurg. 2009 Dec;23(6):612-6. doi: 10.3109/02688690903370297.
PubMed 19922275Catapano JS, Ducruet AF, Nguyen CL, Cole TS, Baranoski JF, Majmundar N, Wilkinson DA, Fredrickson VL, Cavalcanti DD, Lawton MT, Albuquerque FC. A propensity-adjusted comparison of middle meningeal artery embolization versus conventional therapy for chronic subdural hematomas. J Neurosurg. 2021 Feb 26;135(4):1208-1213. doi: 10.3171/2020.9.JNS202781. Print 2021 Oct 1.
PubMed 33636706Moshayedi P, Liebeskind DS. Middle Meningeal Artery Embolization in Chronic Subdural Hematoma: Implications of Pathophysiology in Trial Design. Front Neurol. 2020 Aug 27;11:923. doi: 10.3389/fneur.2020.00923. eCollection 2020.
PubMed 32973670Ironside N, Nguyen C, Do Q, Ugiliweneza B, Chen CJ, Sieg EP, James RF, Ding D. Middle meningeal artery embolization for chronic subdural hematoma: a systematic review and meta-analysis. J Neurointerv Surg. 2021 Oct;13(10):951-957. doi: 10.1136/neurintsurg-2021-017352. Epub 2021 Jun 30.
PubMed 34193592Ku JC, Dmytriw AA, Essibayi MA, Banihashemi MA, Vranic JE, Ghozy S, Altschul D, Regenhardt RW, Stapleton CJ, Yang VXD, Patel AB. Embolic Agent Choice in Middle Meningeal Artery Embolization as Primary or Adjunct Treatment for Chronic Subdural Hematoma: A Systematic Review and Meta-analysis. AJNR Am J Neuroradiol. 2023 Mar;44(3):297-302. doi: 10.3174/ajnr.A7796. Epub 2023 Feb 16.
PubMed 36797028
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Middle Meningeal Artery for Treatment of Chronic Subdural Hematoma; Middle Meningeal Artery Embolization for Chronic Subdural Hematoma (MESH)
- ClinicalTrials.gov ID
- NCT06181994
- Acronym / sponsor ID
- MESH / 2023-15327
- Conditions
- Chronic Subdural Hematoma
- Keywords
- Middle meningeal artery embolization, Endovascular Embolization
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Collaborators
- Geisinger Clinic, Heidelberg University, Henri Mondor University Hospital, Ospedale Policlinico San Martino, Ospedale San Raffaele, Lehigh Valley Hospital, Mayo Clinic, Medical University of South Carolina, New York University, Oregon Health and Science University, Sisters of Mercy University Hospital, Unity Health Toronto, Sutter Health, University of Iowa, Thomas Jefferson University, University Health Network, Toronto, University Hospital, Bordeaux, University of Alabama at Birmingham, University of South Florida, University of Washington, Cornell University, Westchester Medical Center
- Study start
- 5 Dec 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 26 Dec 2023 (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 multi-center retrospective cohort study aims to investigate the real-world outcomes of chronic subdural hematoma treated with MMAE, including clinical effectiveness, recurrence rates, and safety profile.
Detailed description
Chronic subdural hematoma (cSDH) is a prevalent neurosurgical condition marked by the accumulation of blood in the subarachnoid space. Primarily affecting elderly individuals, cSDH is associated with significant morbidity and mortality rates. Current standard treatments for cSDH involve surgical evacuation through burr hole craniotomy or twist-drill craniotomy; however, recent research has illuminated the potential significance of the middle meningeal artery (MMA) in cSDH pathogenesis, suggesting an innovative minimally invasive treatment avenue. The investigator team is attempting to determine whether MMA embolization has demonstrated a favorable safety profile with a low incidence of treatment-related complications.
While traditional surgical interventions have demonstrated positive outcomes in cSDH management, inherent challenges such as perioperative complications, extended hospital stays, and the risk of recurrence persist. Given the emerging insights into cSDH's underlying mechanisms, targeting the MMA presents an intriguing therapeutic alternative. The MMA, which supplies the dura mater's outer layer, has been implicated in cSDH formation and progression due to its fragility and propensity to rupture. By embolization of the MMA (MMAE), the opportunity arises to potentially mitigate bleeding risk and reduce the likelihood of hematoma reaccumulation. Recent case reports and a significant number of retrospective studies have shown encouraging results with MMA embolization as an adjunct or alternative to conventional surgical methods. Nevertheless, most of the reported studies are case series with limited sample sizes. Moreover, a comprehensive assessment of outcomes, complications, and long-term efficacy necessitates well-structured retrospective studies. The findings of this study hold the potential to better understand the outcomes of MMAE for cSDH. This study aims to provide valuable insights that can guide clinical decision-making, potentially leading to improved patient outcomes and more efficient resource utilization,
The following collaborators are also involved in the research:
Hamza Adel Salim Email: HASalim@MDAnderson.org
Adam A Dmytriw MD MPH MSc Email: adam.dmytriw@gmail.com
Rahim Abo Kasem, MD Email: rahim.abokasem@louisville.edu
Name: Muhammed Amir Essibayi, MD Email: m.amir.essibayi@gmail.com
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MMA Embolization | – | –Adults with chronic subdural hematoma who underwent endovascular embolization of the middle meningeal artery as part of routine clinical care, using any embolic material |
| Surgical Evacuation | – | –Adults with chronic subdural hematoma who underwent surgical drainage of the hematoma as part of routine clinical care. |
| Observation only | – | –Adults with chronic subdural hematoma who were managed with clinical and imaging monitoring, without embolization or surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic subdural hematoma
Key inclusion criteria (3 listed)
- Consecutive adult patients (18 yrs. of age or older)
- Endovascular embolization of middle meningeal artery using any embolization material:
- PVA particles; Onyx, N-butyl cyanoacrylate (nBCA) glue; dimethyl sulfoxide, microcoils, polyvinyl alcohol (PVA) with microcoils
Key exclusion criteria (1 listed)
- Endovascular embolization of middle meningeal artery using any other embolization material
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Reaccumulation of Hematoma
Time frame: Within 1 month post MMAE
The percentage of patients who were determined to have a reaccumulation of their hematoma will be tabulated and reported
Rescue surgical evacuation
Time frame: Between 1-3 months post MMAE
The percentage of patients who were determined to require rescue surgical evacuation of their hematoma will be tabulated and reported
17 secondary outcomes
Reaccumulation of Hematoma
Time frame: Between 1-3 months post MMAE
Reaccumulation of Hematoma
Time frame: Between 3-6 months post MMAE
Reaccumulation of Hematoma
Time frame: Between 6-12 months post MMAE
Reaccumulation of Hematoma
Time frame: Between 12-24 months post MMAE
Clinical Outcome at Follow-up Clinical outcome at follow-up
Time frame: Upon study discharge, 1-4 weeks
Clinical Outcome at Follow-up Clinical outcome at follow-up
Time frame: Within 1 month post MMAE
Clinical Outcome at Follow-up Clinical outcome at follow-up
Time frame: Between 1-3 months post MMAE
Clinical Outcome at Follow-up Clinical outcome at follow-up
Time frame: Between 3-6 months post MMAE
Clinical Outcome at Follow-up Clinical outcome at follow-up
Time frame: Between 6-12 months post MMAE
Clinical Outcome at Follow-up Clinical outcome at follow-up
Time frame: Between 12-24 months post MMAE
Complications following MMAE
Time frame: Following the procedure, up to 4 weeks
Timing of Complications
Time frame: Following the procedure, up to 4 weeks
Relatedness of Complications
Time frame: Following the procedure, up to 4 weeks
Duration of Hospital Stay
Time frame: Upon study discharge, up to 24 months
Clinical outcome at discharge
Time frame: Upon study discharge, up to 24 months
Disposition After Discharge
Time frame: Upon study discharge, up to 24 months
Rescue surgical evacuation
Time frame: Between 3-12 months post MMAE
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 21 Sep 2026.
- Background: PubMed 12042376Asghar M, Adhiyaman V, Greenway MW, Bhowmick BK, Bates A. Chronic subdural haematoma in the elderly--a North Wales experience. J R Soc Med. 2002 Jun;95(6):290-2. doi: 10.1258/jrsm.95.6.290.
- Background: PubMed 28935548Sahyouni R, Goshtasbi K, Mahmoodi A, Tran DK, Chen JW. Chronic Subdural Hematoma: A Historical and Clinical Perspective. World Neurosurg. 2017 Dec;108:948-953. doi: 10.1016/j.wneu.2017.09.064. Epub 2017 Sep 19.
- Background: PubMed 30402421Lee HS, Song SW, Chun YI, Choe WJ, Cho J, Moon CT, Koh YC. Complications Following Burr Hole Craniostomy and Closed-System Drainage for Subdural Lesions. Korean J Neurotrauma. 2018 Oct;14(2):68-75. doi: 10.13004/kjnt.2018.14.2.68. Epub 2018 Oct 31.
- Background: PubMed 33632880Shapiro M, Walker M, Carroll KT, Levitt MR, Raz E, Nossek E, Delavari N, Mir O, Nelson PK. Neuroanatomy of cranial dural vessels: implications for subdural hematoma embolization. J Neurointerv Surg. 2021 May;13(5):471-477. doi: 10.1136/neurintsurg-2020-016798. Epub 2021 Feb 25.
- Background: PubMed 33364114Akbik OS, Starling R, Green R, Zhu Y, Lewis J. Delayed Surgical Intervention in Acute Subdural Hematoma. Cureus. 2020 Nov 20;12(11):e11592. doi: 10.7759/cureus.11592.
- Background: PubMed 19922275Mondorf Y, Abu-Owaimer M, Gaab MR, Oertel JM. Chronic subdural hematoma--craniotomy versus burr hole trepanation. Br J Neurosurg. 2009 Dec;23(6):612-6. doi: 10.3109/02688690903370297.
- Background: PubMed 33636706Catapano JS, Ducruet AF, Nguyen CL, Cole TS, Baranoski JF, Majmundar N, Wilkinson DA, Fredrickson VL, Cavalcanti DD, Lawton MT, Albuquerque FC. A propensity-adjusted comparison of middle meningeal artery embolization versus conventional therapy for chronic subdural hematomas. J Neurosurg. 2021 Feb 26;135(4):1208-1213. doi: 10.3171/2020.9.JNS202781. Print 2021 Oct 1.
- Background: PubMed 32973670Moshayedi P, Liebeskind DS. Middle Meningeal Artery Embolization in Chronic Subdural Hematoma: Implications of Pathophysiology in Trial Design. Front Neurol. 2020 Aug 27;11:923. doi: 10.3389/fneur.2020.00923. eCollection 2020.
- Background: PubMed 34193592Ironside N, Nguyen C, Do Q, Ugiliweneza B, Chen CJ, Sieg EP, James RF, Ding D. Middle meningeal artery embolization for chronic subdural hematoma: a systematic review and meta-analysis. J Neurointerv Surg. 2021 Oct;13(10):951-957. doi: 10.1136/neurintsurg-2021-017352. Epub 2021 Jun 30.
- Background: PubMed 36797028Ku JC, Dmytriw AA, Essibayi MA, Banihashemi MA, Vranic JE, Ghozy S, Altschul D, Regenhardt RW, Stapleton CJ, Yang VXD, Patel AB. Embolic Agent Choice in Middle Meningeal Artery Embolization as Primary or Adjunct Treatment for Chronic Subdural Hematoma: A Systematic Review and Meta-analysis. AJNR Am J Neuroradiol. 2023 Mar;44(3):297-302. doi: 10.3174/ajnr.A7796. Epub 2023 Feb 16.
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- 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.
David Altschul, MD principal investigator
Montefiore Medical Center
22 sites in 3 countries: 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 Montefiore Medical Center at 22 sites in 3 countries.
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 3 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States, Canada, Australia. 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?
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 Muhammed Amir Essibayi, MD (347-908-1889, muhammedamir.essibayi@einsteinmed.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reaccumulation of Hematoma (time frame: Within 1 month post MMAE). 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?
On the ClinicalTrials.gov record for NCT06181994, which also lists 10 linked publications.
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 21 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.