Endovascular Embolization of Chronic Subdural Hematomas After Surgery — ENCLOSURE  

Chronic Subdural Hematoma Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Chronic Subdural Hematoma
• Hematoma
• Hematoma, Subdural, Chronic

• NCT number: NCT05220826
• Study type: Interventional
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: Alejandro Tomasello, MD
• Phone: 93489300
• Email: alejandrotomasello@gmail.com
• Status: Recruiting
• Phase: N/A
• Start date: February 11, 2022
• Completion date: December 2023