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Prospective MMA Embolization Registry (PRO-EMMA)

31 mei 2026 bijgewerkt door: Leonard Fetscher, Charite University, Berlin, Germany

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Geschat)

100

Contacten en locaties

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Studiecontact

Studie Contact Back-up

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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)

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
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.
Procedure: Middle Meningeal Artery 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.
Andere namen:
  • MMAE
  • MMA embolization

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Hematoma volume reduction
Tijdsspanne: 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.
3 months post-intervention
Functional outcome (mRS)
Tijdsspanne: 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.
90 days post-intervention
Re-intervention rate
Tijdsspanne: 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.
120 days post-intervention

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Quality of life (EQ-5D-5L)
Tijdsspanne: Baseline (pre-intervention), day 30, day 90, and day 120 post-intervention
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.
Baseline (pre-intervention), day 30, day 90, and day 120 post-intervention
Extended functional outcome (GOS-E)
Tijdsspanne: Baseline (pre-intervention), day 30, day 90, and day 120 post-intervention
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.
Baseline (pre-intervention), day 30, day 90, and day 120 post-intervention
Neurological status (GCS)
Tijdsspanne: Baseline (pre-intervention), day 30, day 90, and day 120 post-intervention
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.
Baseline (pre-intervention), day 30, day 90, and day 120 post-intervention
Symptom severity (Markwalder score)
Tijdsspanne: Baseline (pre-intervention), day 30, day 90, and day 120 post-intervention
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.
Baseline (pre-intervention), day 30, day 90, and day 120 post-intervention
Mortality
Tijdsspanne: 120 days post-intervention
Number of patients with all-cause mortality within 120 days post-intervention.
120 days post-intervention
Treatment failure
Tijdsspanne: Day 90 post intervention
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.
Day 90 post intervention

Medewerkers en onderzoekers

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Sponsor

Charite University, Berlin, Germany

Onderzoekers

  • Hoofdonderzoeker: Jawed Nawabi, MD, MSc, Charite University, Berlin, Germany

Publicaties en nuttige links

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Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 juli 2026

Primaire voltooiing (Geschat)

1 juli 2027

Studie voltooiing (Geschat)

31 januari 2028

Studieregistratiedata

Eerst ingediend

23 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

31 mei 2026

Eerst geplaatst (Werkelijk)

4 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

4 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

31 mei 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • EA1/248/25

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

ONBESLIST

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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