Endovascular Embolization of Chronic Subdural Hematomas After Surgery (ENCLOSURE)

Vall d'Hebron University Hospital (HUVH)

Status: Unknown

Conditions: Chronic Subdural Hematoma

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05220826

PR(AG)575/2021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 280 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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280 participants in 2 patient groups

Surgical drainaje (the standar of care)

No Intervention group

Description:

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.

Surgical drainaje plus early embolization of middle meningeal artery

Experimental group

Description:

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®.

Treatment:

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