Endovascular Embolization of Chronic Subdural Hematomas After Surgery

Chronic Subdural Hematoma Clinical Trial

— ENCLOSURE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05220826
• Other study ID #: PR(AG)575/2021
• Status: Recruiting
• Phase: N/A
• Start date: February 11, 2022
• Est. completion date: December 2023

Study information

• Verified date: March 2022
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: Alejandro Tomasello, MD
• Phone: 93489300
• Email: alejandrotomasello[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 280
• Est. completion date: December 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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®.

Locations

Country	Name	City	State
Spain	Hospital Universitari Vall d'Hebron	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence of chronic subdural hematoma	Defined ad reappearance of symptomatic blood collection or whose thickness is > 1 cm or which determines a deviation from the midline> 5 mm	6 months
Secondary	Functional status	Measured by modified Rankin scale (range, 0 [no disability] to 6 [death])	6 months
Secondary	Safety of endovascular treatment	Measured by complications related to endovascular procedure	6 months
Secondary	Hematoma reabsorption speed	Measured by hematoma volume after treatment on CT imaging	6 months
Secondary	Cumulative days of hospital stay	Measured in both groups (surgical alone and surgical plus endovascular)	6 months