Chronic Subdural HematomasPRO-EMMANCT07626671
Prospective MMA Embolization Registry
An observational study of Chronic Subdural Hematomas, run by Charite University, Berlin, Germany.
Trial summary
Chronic subdural hematoma (cSDH) is a common condition, particularly in older adults, that can substantially impair patients' quality of life, functional independence, and neurological well-being. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Subdural Hematomas
- What is being tested?
- Middle Meningeal Artery Embolization
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 31 Jan 2028
- 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: Adult patients with chronic subdural hematoma presenting to the Department of Neuroradiology, Charité - Universitätsmedizin Berlin who are referred for or deemed eligible for middle meningeal artery embolization (MMAE) as part of routine clinical care.
Who may be able to join
- CT- or MRI-confirmed chronic subdural hematoma (cSDH)
- Planned or completed middle meningeal artery embolization (MMAE), either as primary treatment or as adjunct to surgical evacuation
- Age ≥ 18 years
- Modified Rankin Scale (mRS) ≤ 3 at baseline
- Written informed consent including agreement to structured follow-up (follow-up CT scans and clinical assessments)
- Willingness and ability to participate in structured follow-up assessments (telephone and/or in-person interviews)
Who cannot join
- Acute subdural hematoma requiring emergency neurosurgical intervention
- Missing or incomplete baseline clinical or radiological data
- Unavailability for prospective follow-up (e.g., no fixed address, no telephone contact)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Jawed Nawabi, MD, MSc contact
About this study
Official title: Prospective Outcomes of MMA Embolization: A Prospective Single-center Registry Investigating Endovascular Therapy for Chronic Subdural Hematomas
Chronic subdural hematoma (cSDH) is a common condition, particularly in older adults, that can substantially impair patients' quality of life, functional independence, and neurological well-being. Blood accumulates in the subdural space and persists due to the formation of a highly vascularized outer hematoma membrane. This membrane continuously rebleeds through fragile neovessels, driven in large part by branches of the middle meningeal artery (MMA), preventing spontaneous resolution and promoting hematoma growth. The standard treatment is surgical drainage, but recurrence rates reach up to 30%, largely because surgery does not address the underlying membrane vascularity. Middle meningeal artery embolization (MMAE) is a minimally invasive angiographic procedure that targets this root cause by occluding the arterial supply to the hematoma membrane, thereby reducing rebleeding and promoting resolution. Recent clinical trials and meta-analyses have demonstrated high efficacy and safety of MMAE, both as a standalone treatment and as an adjunct to surgery. Despite this evidence, standardized prospective data on patient selection, predictors of treatment success, and optimal follow-up are still lacking.
PRO-EMMA is a prospective, single-center registry at the Charité - Universitätsmedizin Berlin, a tertiary center consisting of three separate campuses. Pro-Emma systematically collects clinical, radiological, and procedural data from patients with cSDH who undergo MMAE. In addition to routine clinical care, participants undergo a structured follow-up protocol: CT scans within 7 days and at 3 months after the procedure, and standardized assessments of neurological status, functional outcome, and quality of life - using the Glasgow Coma Scale (GCS), Markwalder score, modified Rankin Scale (mRS), Glasgow Outcome Scale Extended (GOS-E), and EQ-5D-5L- before the procedure and at days 30, 90, and 120 post-intervention.
The study tests the hypothesis that MMAE leads to good functional outcomes, rapid hematoma resolution, and low recurrence rates, and that specific clinical, interventional, and imaging features predict treatment success. Findings will help identify which patients benefit most from MMAE, optimize treatment decisions, and establish a practical, evidence-based follow-up standard. The registry aims to enroll 75-150 patients over approximately 12 months.
Read the detailed description
Background and Rationale Chronic subdural hematoma (cSDH) is a common condition, particularly in older adults, that can substantially impair patients' quality of life, functional independence, and neurological well-being. Blood accumulates in the subdural space and persists due to the formation of a highly vascularized outer hematoma membrane, which continuously rebleeds through fragile neovessels driven in large part by branches of the middle meningeal artery (MMA). This prevents spontaneous resolution and promotes hematoma growth. The standard treatment is surgical drainage, but recurrence rates reach up to 30%. Middle meningeal artery embolization (MMAE) targets this root cause by occluding the arterial supply to the hematoma membrane. Recent randomized controlled trials and meta-analyses have demonstrated high efficacy and safety of MMAE, both as standalone treatment and as adjunct to surgery. However, prospective data with standardized, protocol-driven follow-up capturing radiological response, functional status, quality of life at pre-specified time points, and predictive clinical and imaging parameters remain scarce.
Study-Specific Follow-Up Protocol
The MMAE procedure is performed according to clinical routine and standard of care. Study-specific additions consist solely of structured follow-up assessments:
- Functional Outcome and quality-of-life assessments using GCS, Markwalder score, mRS, GOS-E, and EQ-5D-5L at baseline (pre-intervention) and at days 30, 90, and 120 post-intervention, conducted by structured telephone or in-person interview
- Imaging follow-up by cranial CT within 7 days and at 3 months post-intervention.
Treatment decisions are made exclusively on the basis of clinical indication and are independent of study participation.
Data Collection
Data are documented in pseudonymized case report forms. The following domains are recorded:
- Clinical: patient history, GCS, comorbidities, anticoagulation/antiplatelet therapy, symptom course
- Radiological: hematoma volume, architecture, laterality, localization, midline shift, MMA caliber, anatomical MMA variants, foramen spinosum diameter, surgery
- Procedural: embolic agent, technical details, distribution of embolic agent, degree of distal penetration, complications
- Clinical: mRS, GOS-E, EQ-5D-5L, Markwalder score at each time point; re-intervention, recurrence, mortality, symptom course
Data Management and Quality Assurance All participants are assigned a pseudonymized study ID. The assignment list is stored separately and encrypted, with access restricted to authorized study personnel only. Data are stored exclusively on Charité servers (clinical data: 10 years; CT imaging data: 30 years), in compliance with DSGVO, BlnDSG, and applicable federal data protection regulations.
Data entries are checked against predefined plausibility and range rules; inconsistencies or out-of-range values are flagged and resolved before analysis. Source data verification is performed by comparing CRF entries against medical records and imaging reports. Missing values are documented and reported in the statistical analysis but will not be imputed.
Statistical Analysis The study is exploratory. Data will be analyzed using descriptive statistics with 95% confidence intervals. Bivariate correlation analyses (Pearson or Spearman as appropriate) and logistic regression models will be used to identify predictors of treatment success. Potential confounders include patient age, anticoagulation status, hematoma architecture, and procedural variables. A sufficient events-per-variable (EPV) ratio will be ensured in all regression models.
Pre-specified Predictor Variables
The following baseline and procedural variables will be analyzed as potential predictors of radiological and clinical treatment outcome:
- Hematoma morphology on baseline cranial CT, classified according to Nakaguchi et al. (homogeneous, laminar, trabecular, or separated).
- Middle meningeal artery caliber, anatomical variants, and foramen spinosum diameter on baseline imaging.
- Presence and type of anticoagulation or antiplatelet therapy at time of intervention.
- Degree of distal MMA penetration of embolic agent and type of embolic agent used.
Risks and Burden The primary additional burden from study participation consists of: (1) radiation from up to two study-mandated CT scans (within 7 days and at 3 months post-intervention), performed within diagnostically acceptable dose ranges; and (2) minimal time investment for structured interviews at days 30, 90, and 120 (approximately 10-15 minutes each). No additional medical interventions or modifications to clinical care are introduced by study participation.
- Conditions
- Chronic Subdural Hematomas
- Being tested
- Middle Meningeal Artery Embolization
- Keywords
- chronic subdural hematoma, Middle meningeal artery embolization, MMAE, cSDH, Endovascular treatment, Hematoma recurrence, Modified Rankin Scale, Functional outcome, Neuroradiology, Prospective registry
- 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 EmbolizationProcedure or surgery
Also called MMAE, MMA embolization
Minimally invasive endovascular procedure in which the middle meningeal artery (MMA) is catheterized and occluded using approved embolic agents, performed as either primary treatment or adjunct to surgical evacuation for chronic subdural hematoma. The procedure is performed according to clinical routine and standard of care; no modification of the clinical treatment is introduced by study participation.
| Study group | Role | What they receive |
|---|---|---|
| cSDH patients undergoing MMAE | Adult patients (≥18 years) with CT- or MRI-confirmed chronic subdural hematoma who undergo middle meningeal artery embolization (MMAE) as primary treatment or as an adjunct to surgical evacuation at the Charité - Universitätsmedizin Berlin. Receives: Procedure: Middle Meningeal Artery Embolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hematoma volume reduction
Percentage change in hematoma volume (mL) or thickness (mm) on cranial CT from baseline to 3-month follow-up. Higher percentage reduction indicates better radiological response.
Measured: 3 months post-intervention
Functional outcome (mRS)
Functional status assessed by the modified Rankin Scale (mRS), a 7-point scale ranging from 0 (no symptoms) to 6 (death). Higher scores indicate worse functional outcome. Change from baseline to day 90 post-intervention.
Measured: 90 days post-intervention
Re-intervention rate
Number of patients requiring any re-intervention, defined as repeat middle meningeal artery embolization or surgical rescue procedure, within 120 days post-intervention. Higher numbers indicate worse outcome.
Measured: 120 days post-intervention
Secondary outcomes (6)
Quality of life (EQ-5D-5L)
Health-related quality of life assessed by the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L) across five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each rated on a 5-point scale (1-5), plus a visual analogue scale (EQ-VAS, 0-100). Lower dimension scores and higher EQ-VAS scores indicate better health status. Compared to baseline pre-intervention.
Measured: Baseline (pre-intervention), day 30, day 90, and day 120 post-intervention
Extended functional outcome (GOS-E)
Functional recovery assessed by the Glasgow Outcome Scale Extended (GOS-E), an 8-point scale ranging from 1 (death) to 8 (upper good recovery). Higher scores indicate better functional outcome. Compared to baseline pre-intervention.
Measured: Baseline (pre-intervention), day 30, day 90, and day 120 post-intervention
Neurological status (GCS)
Level of consciousness and neurological status assessed by the Glasgow Coma Scale (GCS), a 15-point scale (minimum 3, maximum 15) evaluating eye (1-4), verbal (1-5), and motor responses (1-6). Higher scores indicate better neurological status. Compared to baseline pre-intervention.
Measured: Baseline (pre-intervention), day 30, day 90, and day 120 post-intervention
Symptom severity (Markwalder score)
cSDH-specific neurological grading assessed by the Markwalder Grading Scale (MGS), ranging from 0 (no neurological deficits) to 4 (comatose). Lower scores indicate better neurological status. Compared to baseline pre-intervention.
Measured: Baseline (pre-intervention), day 30, day 90, and day 120 post-intervention
Mortality
Number of patients with all-cause mortality within 120 days post-intervention.
Measured: 120 days post-intervention
Treatment failure
Number of patients with absent or insufficient hematoma resolution, defined as less than 50% reduction in hematoma volume on follow-up cranial CT compared to baseline. Higher numbers indicate worse outcome.
Measured: Day 90 post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Chronic Subdural HematomasStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe 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
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leonard Fetscher, Charite University, Berlin, Germany
- Investigators
- Jawed Nawabi, MD, MSc, Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07626671
- Sponsor's protocol ID
- EA1/248/25
- Acronym
- PRO-EMMA
- Status last verified
- May 2026
- First submitted
- 23 May 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bartek J Jr, Sjavik K, Kristiansson H, Stahl F, Fornebo I, Forander P, Jakola AS. Predictors of Recurrence and Complications After Chronic Subdural Hematoma Surgery: A Population-Based Study. World Neurosurg. 2017 Oct;106:609-614. doi: 10.1016/j.wneu.2017.07.044. Epub 2017 Jul 19.
PubMed 28735129Balser D, Farooq S, Mehmood T, Reyes M, Samadani U. Actual and projected incidence rates for chronic subdural hematomas in United States Veterans Administration and civilian populations. J Neurosurg. 2015 Nov;123(5):1209-15. doi: 10.3171/2014.9.JNS141550. Epub 2015 Mar 20.
PubMed 25794342Nakaguchi H, Tanishima T, Yoshimasu N. Factors in the natural history of chronic subdural hematomas that influence their postoperative recurrence. J Neurosurg. 2001 Aug;95(2):256-62. doi: 10.3171/jns.2001.95.2.0256.
PubMed 11780895Salem MM, Kuybu O, Nguyen Hoang A, Baig AA, Khorasanizadeh M, Baker C, Hunsaker JC, Mendez AA, Cortez G, Davies JM, Narayanan S, Cawley CM, Riina HA, Moore JM, Spiotta AM, Khalessi AA, Howard BM, Hanel R, Tanweer O, Levy EI, Grandhi R, Lang MJ, Siddiqui AH, Kan P, Ogilvy CS, Gross BA, Thomas AJ, Jankowitz BT, Burkhardt JK. Middle Meningeal Artery Embolization for Chronic Subdural Hematoma: Predictors of Clinical and Radiographic Failure from 636 Embolizations. Radiology. 2023 May;307(4):e222045. doi: 10.1148/radiol.222045. Epub 2023 Apr 18.
PubMed 37070990Gillespie CS, Veremu M, Cook WH, Ashraf M, Lee KS, Chedid Y, Alam AM, Karepov Y, Davies BM, Edlmann E, Papanagiotou P, Korfias S, Santarius T, Minett T, Hutchinson PJ, Kolias A. Middle meningeal artery embolization for chronic subdural hematoma: meta-analysis of three randomized controlled trials and review of ongoing trials. Acta Neurochir (Wien). 2025 Jun 10;167(1):166. doi: 10.1007/s00701-025-06587-4.
PubMed 40493076Fiorella D, Monteith SJ, Hanel R, Atchie B, Boo S, McTaggart RA, Zauner A, Tjoumakaris S, Barbier C, Benitez R, Spelle L, Pierot L, Hirsch JA, Froehler M, Arthur AS; STEM Investigators. Embolization of the Middle Meningeal Artery for Chronic Subdural Hematoma. N Engl J Med. 2025 Feb 27;392(9):855-864. doi: 10.1056/NEJMoa2409845. Epub 2024 Nov 20.
PubMed 39565980Liu J, Ni W, Zuo Q, Yang H, Peng Y, Lin Z, Li Z, Wang J, Zhen Y, Luo J, Lin Y, Chen J, Hua X, Lu H, Zhong M, Liu M, Zhang J, Wang Y, Wan J, Li Y, Li T, Mao G, Zhao W, Gao L, Li C, Chen E, Cheng X, Zhang P, Wang Z, Chen L, Zhang Y, Tian B, Shen F, Lei Y, Wu Y, Li Y, Duan G, Xu L, Lv N, Yu J, Xu X, Du Z, Zhang H, Hu J, Li Z, Yuan Q, Zhou Y, Wu G, Zhang L, Gao C, Dai D, Wu X, Zhang Y, Jiang H, Zhao R, Su J, Xu Y, Ospel JM, Majoie CBLM, Goyal M, Li Q, Yang P, Gu Y, Mao Y; MAGIC-MT Investigators. Middle Meningeal Artery Embolization for Nonacute Subdural Hematoma. N Engl J Med. 2024 Nov 21;391(20):1901-1912. doi: 10.1056/NEJMoa2401201.
PubMed 39565989Davies JM, Knopman J, Mokin M, Hassan AE, Harbaugh RE, Khalessi A, Fiehler J, Gross BA, Grandhi R, Tarpley J, Sivakumar W, Bain M, Crowley RW, Link TW, Fraser JF, Levitt MR, Chen PR, Hanel RA, Bernard JD, Jumaa M, Youssef P, Cress MC, Chaudry MI, Shakir HJ, Lesley WS, Billingsley J, Jones J, Koch MJ, Paul AR, Mack WJ, Osbun JW, Dlouhy K, Grossberg JA, Kellner CP, Sahlein DH, Santarelli J, Schirmer CM, Singer J, Liu JJ, Majjhoo AQ, Wolfe T, Patel NV, Roark C, Siddiqui AH; EMBOLISE Investigators. Adjunctive Middle Meningeal Artery Embolization for Subdural Hematoma. N Engl J Med. 2024 Nov 21;391(20):1890-1900. doi: 10.1056/NEJMoa2313472.
PubMed 39565988
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Outcomes of MMA Embolization: A Prospective Single-center Registry Investigating Endovascular Therapy for Chronic Subdural Hematomas
- ClinicalTrials.gov ID
- NCT07626671
- Acronym / sponsor ID
- PRO-EMMA / EA1/248/25
- Conditions
- Chronic Subdural Hematomas
- Keywords
- chronic subdural hematoma, Middle meningeal artery embolization, MMAE, cSDH, Endovascular treatment, Hematoma recurrence, Modified Rankin Scale, Functional outcome
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 4 Jun 2026 (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 condition, particularly in older adults, that can substantially impair patients' quality of life, functional independence, and neurological well-being. Blood accumulates in the subdural space and persists due to the formation of a highly vascularized outer hematoma membrane. This membrane continuously rebleeds through fragile neovessels, driven in large part by branches of the middle meningeal artery (MMA), preventing spontaneous resolution and promoting hematoma growth. The standard treatment is surgical drainage, but recurrence rates reach up to 30%, largely because surgery does not address the underlying membrane vascularity. Middle meningeal artery embolization (MMAE) is a minimally invasive angiographic procedure that targets this root cause by occluding the arterial supply to the hematoma membrane, thereby reducing rebleeding and promoting resolution. Recent clinical trials and meta-analyses have demonstrated high efficacy and safety of MMAE, both as a standalone treatment and as an adjunct to surgery. Despite this evidence, standardized prospective data on patient selection, predictors of treatment success, and optimal follow-up are still lacking.
PRO-EMMA is a prospective, single-center registry at the Charité - Universitätsmedizin Berlin, a tertiary center consisting of three separate campuses. Pro-Emma systematically collects clinical, radiological, and procedural data from patients with cSDH who undergo MMAE. In addition to routine clinical care, participants undergo a structured follow-up protocol: CT scans within 7 days and at 3 months after the procedure, and standardized assessments of neurological status, functional outcome, and quality of life - using the Glasgow Coma Scale (GCS), Markwalder score, modified Rankin Scale (mRS), Glasgow Outcome Scale Extended (GOS-E), and EQ-5D-5L- before the procedure and at days 30, 90, and 120 post-intervention.
The study tests the hypothesis that MMAE leads to good functional outcomes, rapid hematoma resolution, and low recurrence rates, and that specific clinical, interventional, and imaging features predict treatment success. Findings will help identify which patients benefit most from MMAE, optimize treatment decisions, and establish a practical, evidence-based follow-up standard. The registry aims to enroll 75-150 patients over approximately 12 months.
Detailed description
Background and Rationale Chronic subdural hematoma (cSDH) is a common condition, particularly in older adults, that can substantially impair patients' quality of life, functional independence, and neurological well-being. Blood accumulates in the subdural space and persists due to the formation of a highly vascularized outer hematoma membrane, which continuously rebleeds through fragile neovessels driven in large part by branches of the middle meningeal artery (MMA). This prevents spontaneous resolution and promotes hematoma growth. The standard treatment is surgical drainage, but recurrence rates reach up to 30%. Middle meningeal artery embolization (MMAE) targets this root cause by occluding the arterial supply to the hematoma membrane. Recent randomized controlled trials and meta-analyses have demonstrated high efficacy and safety of MMAE, both as standalone treatment and as adjunct to surgery. However, prospective data with standardized, protocol-driven follow-up capturing radiological response, functional status, quality of life at pre-specified time points, and predictive clinical and imaging parameters remain scarce.
Study-Specific Follow-Up Protocol
The MMAE procedure is performed according to clinical routine and standard of care. Study-specific additions consist solely of structured follow-up assessments:
- Functional Outcome and quality-of-life assessments using GCS, Markwalder score, mRS, GOS-E, and EQ-5D-5L at baseline (pre-intervention) and at days 30, 90, and 120 post-intervention, conducted by structured telephone or in-person interview
- Imaging follow-up by cranial CT within 7 days and at 3 months post-intervention.
Treatment decisions are made exclusively on the basis of clinical indication and are independent of study participation.
Data Collection
Data are documented in pseudonymized case report forms. The following domains are recorded:
- Clinical: patient history, GCS, comorbidities, anticoagulation/antiplatelet therapy, symptom course
- Radiological: hematoma volume, architecture, laterality, localization, midline shift, MMA caliber, anatomical MMA variants, foramen spinosum diameter, surgery
- Procedural: embolic agent, technical details, distribution of embolic agent, degree of distal penetration, complications
- Clinical: mRS, GOS-E, EQ-5D-5L, Markwalder score at each time point; re-intervention, recurrence, mortality, symptom course
Data Management and Quality Assurance All participants are assigned a pseudonymized study ID. The assignment list is stored separately and encrypted, with access restricted to authorized study personnel only. Data are stored exclusively on Charité servers (clinical data: 10 years; CT imaging data: 30 years), in compliance with DSGVO, BlnDSG, and applicable federal data protection regulations.
Data entries are checked against predefined plausibility and range rules; inconsistencies or out-of-range values are flagged and resolved before analysis. Source data verification is performed by comparing CRF entries against medical records and imaging reports. Missing values are documented and reported in the statistical analysis but will not be imputed.
Statistical Analysis The study is exploratory. Data will be analyzed using descriptive statistics with 95% confidence intervals. Bivariate correlation analyses (Pearson or Spearman as appropriate) and logistic regression models will be used to identify predictors of treatment success. Potential confounders include patient age, anticoagulation status, hematoma architecture, and procedural variables. A sufficient events-per-variable (EPV) ratio will be ensured in all regression models.
Pre-specified Predictor Variables
The following baseline and procedural variables will be analyzed as potential predictors of radiological and clinical treatment outcome:
- Hematoma morphology on baseline cranial CT, classified according to Nakaguchi et al. (homogeneous, laminar, trabecular, or separated).
- Middle meningeal artery caliber, anatomical variants, and foramen spinosum diameter on baseline imaging.
- Presence and type of anticoagulation or antiplatelet therapy at time of intervention.
- Degree of distal MMA penetration of embolic agent and type of embolic agent used.
Risks and Burden The primary additional burden from study participation consists of: (1) radiation from up to two study-mandated CT scans (within 7 days and at 3 months post-intervention), performed within diagnostically acceptable dose ranges; and (2) minimal time investment for structured interviews at days 30, 90, and 120 (approximately 10-15 minutes each). No additional medical interventions or modifications to clinical care are introduced by study participation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cSDH patients undergoing MMAE | – | Procedure: Middle Meningeal Artery EmbolizationAdult patients (≥18 years) with CT- or MRI-confirmed chronic subdural hematoma who undergo middle meningeal artery embolization (MMAE) as primary treatment or as an adjunct to surgical evacuation at the Charité - Universitätsmedizin Berlin. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with chronic subdural hematoma presenting to the Department of Neuroradiology, Charité - Universitätsmedizin Berlin who are referred for or deemed eligible for middle meningeal artery embolization (MMAE) as part of routine clinical care.
Key inclusion criteria (6 listed)
- CT- or MRI-confirmed chronic subdural hematoma (cSDH)
- Planned or completed middle meningeal artery embolization (MMAE), either as primary treatment or as adjunct to surgical evacuation
- Age ≥ 18 years
- Modified Rankin Scale (mRS) ≤ 3 at baseline
- Written informed consent including agreement to structured follow-up (follow-up CT scans and clinical assessments)
Key exclusion criteria (3 listed)
- Acute subdural hematoma requiring emergency neurosurgical intervention
- Missing or incomplete baseline clinical or radiological data
- Unavailability for prospective follow-up (e.g., no fixed address, no telephone contact)
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 EmbolizationAlso: MMAE, MMA embolizationMinimally invasive endovascular procedure in which the middle meningeal artery (MMA) is catheterized and occluded using approved embolic agents, performed as either primary treatment or adjunct to surgical evacuation for chronic subdural hematoma. The procedure is performed according to clinical routine and standard of care; no modification of the clinical treatment is introduced by study participation. | Procedure or surgery | cSDH patients undergoing MMAE |
Primary outcome
Hematoma volume reduction
Time frame: 3 months post-intervention
Percentage change in hematoma volume (mL) or thickness (mm) on cranial CT from baseline to 3-month follow-up. Higher percentage reduction indicates better radiological response.
Functional outcome (mRS)
Time frame: 90 days post-intervention
Functional status assessed by the modified Rankin Scale (mRS), a 7-point scale ranging from 0 (no symptoms) to 6 (death). Higher scores indicate worse functional outcome. Change from baseline to day 90 post-intervention.
Re-intervention rate
Time frame: 120 days post-intervention
Number of patients requiring any re-intervention, defined as repeat middle meningeal artery embolization or surgical rescue procedure, within 120 days post-intervention. Higher numbers indicate worse outcome.
6 secondary outcomes
Quality of life (EQ-5D-5L)
Time frame: Baseline (pre-intervention), day 30, day 90, and day 120 post-intervention
Extended functional outcome (GOS-E)
Time frame: Baseline (pre-intervention), day 30, day 90, and day 120 post-intervention
Neurological status (GCS)
Time frame: Baseline (pre-intervention), day 30, day 90, and day 120 post-intervention
Symptom severity (Markwalder score)
Time frame: Baseline (pre-intervention), day 30, day 90, and day 120 post-intervention
Mortality
Time frame: 120 days post-intervention
Treatment failure
Time frame: Day 90 post intervention
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 4 Jun 2026.
- Background: PubMed 28735129Bartek J Jr, Sjavik K, Kristiansson H, Stahl F, Fornebo I, Forander P, Jakola AS. Predictors of Recurrence and Complications After Chronic Subdural Hematoma Surgery: A Population-Based Study. World Neurosurg. 2017 Oct;106:609-614. doi: 10.1016/j.wneu.2017.07.044. Epub 2017 Jul 19.
- Background: PubMed 25794342Balser D, Farooq S, Mehmood T, Reyes M, Samadani U. Actual and projected incidence rates for chronic subdural hematomas in United States Veterans Administration and civilian populations. J Neurosurg. 2015 Nov;123(5):1209-15. doi: 10.3171/2014.9.JNS141550. Epub 2015 Mar 20.
- Background: PubMed 11780895Nakaguchi H, Tanishima T, Yoshimasu N. Factors in the natural history of chronic subdural hematomas that influence their postoperative recurrence. J Neurosurg. 2001 Aug;95(2):256-62. doi: 10.3171/jns.2001.95.2.0256.
- Background: PubMed 37070990Salem MM, Kuybu O, Nguyen Hoang A, Baig AA, Khorasanizadeh M, Baker C, Hunsaker JC, Mendez AA, Cortez G, Davies JM, Narayanan S, Cawley CM, Riina HA, Moore JM, Spiotta AM, Khalessi AA, Howard BM, Hanel R, Tanweer O, Levy EI, Grandhi R, Lang MJ, Siddiqui AH, Kan P, Ogilvy CS, Gross BA, Thomas AJ, Jankowitz BT, Burkhardt JK. Middle Meningeal Artery Embolization for Chronic Subdural Hematoma: Predictors of Clinical and Radiographic Failure from 636 Embolizations. Radiology. 2023 May;307(4):e222045. doi: 10.1148/radiol.222045. Epub 2023 Apr 18.
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- Individual participant dataSharing planned: Undecided
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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.
Jawed Nawabi, MD, MSc contact
Jawed Nawabi, MD, MSc principal investigator
Charite University, Berlin, Germany
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Subdural Hematomas, run by Charite University, Berlin, Germany.
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 6 inclusion and 3 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: opening soon, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Leonard Fetscher, MD (+49 030 450 627 426, Leonard.fetscher@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hematoma volume reduction (time frame: 3 months post-intervention). The study lists 3 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 NCT07626671, which also lists 8 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 4 Jun 2026.