NCT04511572: ELIMINATE

Embolization of Middle Meningeal Artery in Chronic Subdural Hematoma

Recruiting now NA Last updated 31 July 2024

What this trial tests

NA trial testing embolization of the middle meningeal artery in Chronic Subdural Hematomas in 170 participants. Currently enrolling.

Timeline

10 December 2020

Primary endpoint
1 July 2025

1 October 2025

Quick facts

Lead sponsor	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	170
Start date	10 December 2020
Primary completion	1 July 2025
Estimated completion	1 October 2025
Sites	1 location across Netherlands

Drugs / interventions tested

• embolization of the middle meningeal artery

Conditions studied

• Chronic Subdural Hematomas — all drugs for Chronic Subdural Hematomas →

Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) — full company profile →

Who can join

Adults 50 to 90, any sex, with Chronic Subdural Hematomas. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Chronic subdural hematoma (cSDH) is a common neurological affliction which affects mostly frail and elderly patients. Surgical evacuation by using burr hole craniostomy (BHC) is the most frequently used treatment but carries a recurrence rate varying between 10-30% in the literature. Especially in this frail population re-operation is undesirable. Embolization of the middle meningeal artery is an adjuvant treatment which has been reported in multiple case reports and larger case series, showing a beneficial effect on recurrence rate, reducing it to \<5%, without complications.

Objectives: Primary: To evaluate whether additional embolization of the middle meningeal artery after surgery for cSDH reduces the recurrent surgery rate. Secondary: to evaluate whether the use of middle meningeal artery embolization after surgical treatment in symptomatic cSDH patients increases quality of life (SF-36 and the EQ-5D-5L), performance in activities of daily living (AMC Linear Disability Score), functional outcome (mRS), cognitive functioning (MOCA) and reduces mortality, occurrence of complications, recurrence rate, size and volume of the hematoma, neurological impairment (mNIHSS, Markwalder score) and the use of care and health-related costs (iMCQ and iPCQ).

Study design: Multicenter, randomized controlled open-label superiority trial. Study population: Patients diagnosed with a cSDH who require surgery. Intervention: The intervention group will receive embolization in addition to standard surgical treatment. The control group will receive surgery only.

Main study endpoint: The number of patients who require reoperation within 24 weeks after the intervention.

Symptomatic cSDH patients will undergo peri-operative embolization of the middle meningeal artery until 72 hours after surgical treatment. Complications are monitored during hospital admission and follow-up. Radiological and clinical follow-up is at eight, 16 and 24 weeks post-intervention with a CT-scan of the head and assessment of mRS, MOCA, mNIHSS, Markwalder score, SF-36, EQ-5D-5L, ALDS, iMCQ and iPCQ. Standard care after surgery entails outpatient follow-up with on average two CT-scans, indicated by clinical signs and symptoms.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Safety and efficacy comparison of embolic agents for middle meningeal artery embolization for chronic subdural hematoma.
   Ellens NR, Schartz D, Kohli G, Rahmani R, et al · · 2024 · cited 20× · PMID 37828746 · DOI 10.7461/jcen.2023.e2023.04.002
2. Multidisciplinary consensus-based statement on the current role of middle meningeal artery embolization (MMAE) in chronic SubDural hematoma (cSDH).
   Bartek J, Biondi A, Bonhomme V, Castellan L, et al · · 2024 · cited 13× · PMID 39717364 · DOI 10.1016/j.bas.2024.104143
3. Newer treatment paradigm improves outcomes in the most common neurosurgical disease of the elderly: a literature review of middle meningeal artery embolization for chronic subdural hematoma.
   Debs LH, Walker SE, Rahimi SY. · · 2024 · cited 13× · PMID 38691299 · DOI 10.1007/s11357-024-01173-5
4. Embolization of Middle Meningeal Artery in Patients with Chronic Subdural Hematoma: A Systematic Review and Meta-Analysis of Randomized-Controlled Clinical Trials.
   Papageorgiou NM, Palaiodimou L, Melanis K, Theodorou A, et al · · 2025 · cited 8× · PMID 40363895 · DOI 10.3390/jcm14092862
5. A systematic review of middle meningeal artery embolization for minimally symptomatic chronic subdural haematomas that do not require immediate evacuation.
   Rojas-Villabona A, Mohamed S, Kennion O, Padmanabhan R, et al · · 2023 · cited 7× · PMID 38021007 · DOI 10.1016/j.bas.2023.102672
6. Middle Meningeal Artery Embolization for Chronic Subdural Hematoma: A Review of Established and Emerging Embolic Agents.
   Tudor T, Capone S, Vivanco-Suarez J, Salem MM, et al · · 2024 · cited 5× · PMID 41586060 · DOI 10.1161/svin.123.000906
7. 2024 middle meningeal artery embolization trials: A comprehensive review of past, recent, and ongoing trials.
   Gajjar AA, Naqvi A, Chen JY, Custozzo A, et al · · 2025 · cited 5× · PMID 40183372 · DOI 10.1177/15910199251329970
8. Updated systematic review of current randomised controlled trials in chronic subdural haematoma.
   Fakhry R, Yesildal C, Bartek J, Duerinck J, et al · · 2025 · PMID 41196366 · DOI 10.1007/s00701-025-06683-5