Prospective MMA Embolization Registry
ConditionChronic Subdural Hematomas
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCharite University, Berlin, Germany
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Middle Meningeal Artery Embolization
Procedure/SurgeryMinimally 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.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: cSDH patients undergoing MMAE1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
3 months post-intervention2
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.
Time frame
90 days post-intervention3
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.
Time frame
120 days post-interventionSecondary outcomes
1
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.
Time frame
Baseline (pre-intervention), day 30, day 90, and day 120 post-intervention2
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.
Time frame
Baseline (pre-intervention), day 30, day 90, and day 120 post-intervention3
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.
Time frame
Baseline (pre-intervention), day 30, day 90, and day 120 post-intervention4
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.
Time frame
Baseline (pre-intervention), day 30, day 90, and day 120 post-interventionLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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