NCT05220826: ENCLOSURE

Early eNdovascular Embolization for Chronic subduraL hematOma After SUrgery and Prevention of REcurrence (ENCLOSURE)

Status unknown NA Last updated 4 March 2022

What this trial tests

NA trial testing Post surgical embolization of middle meningeal artery with liquid embolic agents (ethylene vinyl alcohol copolymers as Onix, Squid, Phil or Libro) in Chronic Subdural Hematoma in 280 participants. Status unknown.

Timeline

11 February 2022

Primary endpoint
1 June 2023

1 December 2023

Quick facts

Lead sponsor	Hospital Universitari Vall d'Hebron Research Institute
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	280
Start date	11 February 2022
Primary completion	1 June 2023
Estimated completion	1 December 2023
Sites	1 location across Spain

Drugs / interventions tested

• Post surgical embolization of middle meningeal artery with liquid embolic agents (ethylene vinyl alcohol copolymers as Onix, Squid, Phil or Libro)

Conditions studied

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

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Who can join

Adults 18 to 99, any sex, with Chronic Subdural Hematoma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Recurrence of chronic subdural hematoma
  Time frame: 6 months
  Defined ad reappearance of symptomatic blood collection or whose thickness is \> 1 cm or which determines a deviation from the midline\> 5 mm

Sponsor's own description

Chronic subdural hematomas (CSH) are one of the most frequent pathologies in emergency neurosurgical practice. Standard therapy for symptomatic CSH is surgical drainage. However, the recurrence rate after surgery is high (10 to 20% in the most of series, although it has been reported from 2 to 37%). Middle meningeal artery embolization (MMAE) is a promising minimally invasive procedure that has recently been proposed as an alternative or adjunctive treatment to surgery. The investigators hypothesize that early post operative endovascular treatment can reduce the recurrence rate in high-risk patients, improving neurological outcomes by reducing the need for reinterventions, hospitalizations, and post-operative complications. The aim of the investigators is to analyze the efficacy of and safety of early post-surgical embolization of MMA in reducing the risk of CSH recurrence.

Publications & conference data

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

1. 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
2. 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
3. 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
4. 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