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ENCLOSURE: Endovascular Embolization of Chronic Subdural Hematomas After Surgery

Sponsor
Hospital Universitari Vall d'Hebron Research Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT05220826
Collaborator
(none)
280
Enrollment
1
Location
2
Arms
21.6
Anticipated Duration (Months)
13
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Post surgical embolization of middle meningeal artery with liquid embolic agents (ethylene vinyl alcohol copolymers as Onix, Squid, Phil or Libro)
 N/A

Detailed Description

The study was designed as an open-label, multicenter randomized trial involving patients with symptomatic CSH and surgical evacuation criteria. Patients will be randomized in a 1: 1 ratio to receive surgical drainage (the standard of care) or surgical drainage plus early endovascular embolization of MMA (< 72 hours after surgery). Endovascular procedures will be performed with non-adhesive embolizing fluids. The primary outcome will be the recurrence of CSH at 6 months and secondary outcomes will be the risk reduction of recurrence in patients with risk factors, functional status measured by the modified Rankin scale (range, 0 [no disability] to 6 [death]) at 6 months and complications related to endovascular procedure.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
280 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Masking Description:
Primary outcome will be assesed by a blinded external core lab
Primary Purpose:
Treatment
Official Title:
Early eNdovascular Embolization for Chronic subduraL hematOma After SUrgery and Prevention of REcurrence (ENCLOSURE)
Actual Study Start Date :
Feb 11, 2022
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Surgical drainaje (the standar of care)

Surgery will consist of performing a craniotomy (burr hole or drill) and evacuation of the hematoma. Depending on the operator, the surgical procedure may incorporate the use of subdural space drainage devices (e.g. Jackson Pratt drainage) connected to a soft suction reservoir. If used, these devices should be removed within 48 hours of installation.
Experimental: Surgical drainaje plus early embolization of middle meningeal artery

The endovascular procedure will be performed until 72 hours after surgical evacuation of chronic subdural hematoma. Embolization will be performed with non-adhesive embolizing fluids such as Onix®, Phil®, Squid® or Libro®.

Procedure: Post surgical embolization of middle meningeal artery with liquid embolic agents (ethylene vinyl alcohol copolymers as Onix, Squid, Phil or Libro)
The endovascular procedure will be performed until 72 hours after surgical evacuation of chronic subdural hematoma. Embolization will be performed with non-adhesive embolizing fluids such as Onix®, Phil®, Squid® or Libro®.
Other Names:
  • Liquid embolic agent: Onix (ethylene vinyl alcohol copolymer), Medtronic.
  • Liquid embolic agent: Squid (ethylene vinyl alcohol copolymer), Balt.
  • Liquid embolic agent: Phil (copolymer disolved in DMSO), Microvention-Terumo.
  • Liquid embolic agent: Libro (ethylene vinyl aalcohol copolymer), Invamed.

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Recurrence of chronic subdural hematoma [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

    Secondary Outcome Measures

    1. Functional status [6 months]

      Measured by modified Rankin scale (range, 0 [no disability] to 6 [death])

    2. Safety of endovascular treatment [6 months]

      Measured by complications related to endovascular procedure

    3. Hematoma reabsorption speed [6 months]

      Measured by hematoma volume after treatment on CT imaging

    4. Cumulative days of hospital stay [6 months]

      Measured in both groups (surgical alone and surgical plus endovascular)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Chronic subdural hematoma equal or greater than 10 mm, midline shift equal or greater than 5 mm or neurological symptoms attributable to mass effect.

    • Recent diagnosis or recurrence

    • Surgical treatment performed < 72 hours

    • Informed consent signed by the patient or they responsible family member

    Exclusion Criteria:

    • Advanced disease with life expectancy < 6 months

    • Condition that contraindicated endovascular procedure: Pregnancy, renal failure defined as creatinine clearence < 30 ml/min, allergy to iodinated contrast.

    • Unavailability for follow up st 6 months

    • Patient expressly refuses treatment

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital Universitari Vall d'Hebron Barcelona Spain 08035

    Sponsors and Collaborators

    • Hospital Universitari Vall d'Hebron Research Institute

    Investigators

    • Study Chair: Alejandro Tomasello, MD, Hospital Universitari Vall d'hebron Barcelona, Spain
    • Principal Investigator: Jose Luis Cuevas, MD, Hospital de Puerto Montt, Puerto Montt, Chile.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hospital Universitari Vall d'Hebron Research Institute
    ClinicalTrials.gov Identifier:
    NCT05220826
    Other Study ID Numbers:
    • PR(AG)575/2021
    First Posted:
    Feb 2, 2022
    Last Update Posted:
    Mar 21, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Hospital Universitari Vall d'Hebron Research Institute
    Middle meningeal artery embolization
    Additional relevant MeSH terms:
    Hematoma, Subdural
    Hematoma, Subdural, Chronic
    Hematoma
    Ethanol
    Ethylene

    Study Results

    No Results Posted as of Mar 21, 2022