Endovascular Embolization of Chronic Subdural Hematomas After Surgery (ENCLOSURE)

  • STATUS
    Recruiting
  • End date
    Dec 7, 2023
  • participants needed
    280
  • sponsor
    Hospital Universitari Vall d'Hebron Research Institute
Updated on 7 April 2022

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.

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.

Details
Condition Chronic Subdural Hematoma
Treatment Post surgical embolization of middle meningeal artery with liquid embolic agents (ethylene vinyl alcohol copolymers as Onix, Squid, Phil or Libro)
Clinical Study IdentifierNCT05220826
SponsorHospital Universitari Vall d'Hebron Research Institute
Last Modified on7 April 2022

Eligibility

Yes No Not Sure

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
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