Clinical trial NCT05220826: Endovascular Embolization of Chronic Subdural Hematomas After Surgery
Official title: Early eNdovascular Embolization for Chronic subduraL hematOma After SUrgery and Prevention of REcurrence (ENCLOSURE)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Subdural Hematoma
Keywords: Middle meningeal artery embolization
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
First posted: 2022-02-02
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Recurrence of chronic subdural hematoma
timeFrame: 6 months
Secondary outcomes:
measure: Functional status
timeFrame: 6 months
measure: Safety of endovascular treatment
timeFrame: 6 months
measure: Hematoma reabsorption speed
timeFrame: 6 months
measure: Cumulative days of hospital stay
timeFrame: 6 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
Study officials:
affiliation: Hospital Universitari Vall d'hebron Barcelona, Spain
name: Alejandro Tomasello, MD
role: STUDY_CHAIR
affiliation: Hospital de Puerto Montt, Puerto Montt, Chile.
name: Jose Luis Cuevas, MD
role: PRINCIPAL_INVESTIGATOR
References: