Prospective MMA Embolization Registry

NCT07626671 | Not Yet Recruiting

• 1 other identifier: EA1/248/25
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Chronic Subdural Hematomas

Keywords

chronic subdural hematoma; Middle meningeal artery embolization; MMAE; cSDH; Endovascular treatment; Hematoma recurrence; Modified Rankin Scale; Functional outcome; Neuroradiology; Prospective registry

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  120 days post-intervention

Secondary Outcomes (6)

• Quality of life (EQ-5D-5L)

  Baseline (pre-intervention), day 30, day 90, and day 120 post-intervention

• Extended functional outcome (GOS-E)

  Baseline (pre-intervention), day 30, day 90, and day 120 post-intervention

• Neurological status (GCS)

  Baseline (pre-intervention), day 30, day 90, and day 120 post-intervention

• Symptom severity (Markwalder score)

  Baseline (pre-intervention), day 30, day 90, and day 120 post-intervention

• Mortality

  120 days post-intervention

Study Arms (1)

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

Interventions

Middle Meningeal Artery Embolization PROCEDURE

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.

Also known as: MMAE, MMA embolization

cSDH patients undergoing MMAE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Related Publications (8)

• 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.

  PMID: 28735129 BACKGROUND

• Balser 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.

  PMID: 25794342 BACKGROUND

• Nakaguchi 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.

  PMID: 11780895 BACKGROUND

• Salem 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.

  PMID: 37070990 BACKGROUND

• Gillespie 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.

  PMID: 40493076 BACKGROUND

• Fiorella 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.

  PMID: 39565980 BACKGROUND

• Liu 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.

  PMID: 39565989 BACKGROUND

• Davies 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.

  PMID: 39565988 BACKGROUND

MeSH Terms

Conditions

Hematoma, Subdural, Chronic

Condition Hierarchy (Ancestors)

Hematoma, Subdural; Intracranial Hemorrhage, Traumatic; Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Vascular Diseases; Cardiovascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematoma; Hemorrhage; Wounds and Injuries

Study Officials

• Jawed Nawabi, MD, MSc

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leonard Fetscher, MD

CONTACT

+49 030 450 627 426; Leonard.fetscher@charite.de

Jawed Nawabi, MD, MSc

CONTACT

jawed.nawabi@charite.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 23, 2026
• First Posted: June 4, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): January 31, 2028
• Last Updated: June 4, 2026

Record last verified: 2026-05