Endovascular Embolization of Chronic Subdural Hematomas After Surgery

NCT ID: NCT05220826

Last Updated: 2022-03-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 280 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-11
• Study Completion Date: 2023-12-31

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.

Conditions

Chronic Subdural Hematoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Surgical drainaje (the standar of care)

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Surgical drainaje plus early embolization of middle meningeal artery

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®.

Group Type: EXPERIMENTAL

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

Intervention Type: PROCEDURE

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®.

Interventions

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®.

Intervention Type: PROCEDURE

Other Intervention Names

Liquid embolic agent: Onix (ethylene vinyl alcohol copolymer), Medtronic.; Liquid embolic agent: Squid (ethylene vinyl alcohol copolymer), Balt.; Liquid embolic agent: Phil (copolymer disolved in DMSO), Microvention-Terumo.; Liquid embolic agent: Libro (ethylene vinyl aalcohol copolymer), Invamed.

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Universitari Vall d'Hebron Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alejandro Tomasello, MD

Role: STUDY_CHAIR

Hospital Universitari Vall d'hebron Barcelona, Spain

Jose Luis Cuevas, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Puerto Montt, Puerto Montt, Chile.

Locations

Hospital Universitari Vall d'Hebron

Barcelona, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Alejandro Tomasello, MD

Role: CONTACT

alejandrotomasello@gmail.com

93489300 ext. 6441

Jose Luis Cuevas, MD

Role: CONTACT

cuevasseguel.joseluis@gmail.com

93489300 ext. 6748

Facility Contacts

Alejandro Tomasello, MD

Role: primary

alejandrotomasello@gmail.com

93489300 ext. 6441

Jose Luis Cuevas, MD

Role: backup

cuevasseguel.joseluis@gmail.com

93489300 ext. 6748

Other Identifiers

PR(AG)575/2021

Identifier Type: -

Identifier Source: org_study_id