Endovascular Embolization of Chronic Subdural Hematomas After Surgery

NCT05220826 | Unknown

• 1 other identifier: PR(AG)575/2021
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Subdural Hematoma

Keywords

Middle meningeal artery embolization

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Functional status

  6 months

• Safety of endovascular treatment

  6 months

• Hematoma reabsorption speed

  6 months

• Cumulative days of hospital stay

  6 months

Study Arms (2)

Surgical drainaje (the standar of care)

NO INTERVENTION

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

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®.

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

Interventions

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

Also known as: 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.

Surgical drainaje plus early embolization of middle meningeal artery

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead

Study Sites (1)

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

RECRUITING

MeSH Terms

Conditions

Hematoma, Subdural, Chronic

Interventions

Ethanol; ethylene-vinyl alcohol copolymer; Dimethyl Sulfoxide

Condition Hierarchy (Ancestors)

Hematoma, Subdural; Intracranial Hemorrhage, Traumatic; Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Vascular Diseases; Cardiovascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematoma; Hemorrhage; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals; Sulfoxides; Sulfur Compounds

Study Officials

• Alejandro Tomasello, MD

  Hospital Universitari Vall d'hebron Barcelona, Spain

  STUDY CHAIR

• Jose Luis Cuevas, MD

  Hospital de Puerto Montt, Puerto Montt, Chile.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alejandro Tomasello, MD

CONTACT

93489300; alejandrotomasello@gmail.com

Jose Luis Cuevas, MD

CONTACT

93489300; cuevasseguel.joseluis@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Primary outcome will be assesed by a blinded external core lab
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2022
• First Posted: February 2, 2022
• Study Start: February 11, 2022
• Primary Completion: June 1, 2023
• Study Completion: December 1, 2023
• Last Updated: March 21, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)