Middle Meningeal Artery Embolization for Chronic Subdural Hematoma

NCT ID: NCT04065113

Last Updated: 2025-07-22

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-09-19
• Study Completion Date: 2025-06-01

Brief Summary

Endovascular middle meningeal artery (MMA) embolization is an emerging treatment for chronic subdural hematoma (cSDH). There is preliminary data to suggest that this minimally invasive therapy may be more efficacious and equally as safe compared to conventional, more invasive surgery. This study seeks to assess the safety and efficacy of middle meningeal artery embolization for chronic subdural hematoma as an adjunct to standard treatments, which include medical management and surgical evacuation.

Detailed Description

This study seeks to assess the safety and efficacy of middle meningeal artery embolization for chronic subdural hematoma in addition to standard treatments, which include close observation and surgical evacuation. Middle meningeal artery embolization has emerged recently as a minimally invasive and successful method of preventing re-accumulation of subdural hematoma, particularly for patients that are not obvious surgical candidates or those with recurrent or refractory hematomas. The outcomes of these two groups of patients who undergo middle meningeal artery embolization will be compared to matched historical controls.

Middle meningeal artery embolization is a minimally invasive angiography procedure completed with use of fluoroscopy. Access is obtained through the femoral or radial artery and a catheter is advanced to the MMA. Polyvinyl alcohol particles are then injected to seal off this portion of the artery and prevent any further blood flow into the subdural hematoma. Hemostasis is obtained at the access site and the patient is observed for 24-48 hours on a neurological care unit before discharge.

A head CT, NIHSS, and modified Rankin Score will be repeated on the following schedule: • Pre-Procedure

• 24 hours post procedure
• 7-10 days post procedure
• 30 days post procedure
• 90 days post procedure

Patients with chronic subdural hematoma undergo CT scans and neurologic assessments on hospital admission, as well as follow up CT scans and neurologic assessments to assess for any change in neurologic status or hematoma size. This study utilizes a standard of care follow up schedule to avoid exposing participants to extra radiation. Participants will be followed for study related purposes for 90 days.

Conditions

Chronic Subdural Hematoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Embolization Only

Medically managed patient receives middle meningeal artery embolization

Middle Meningeal Artery Embolization with polyvinyl alcohol particles (PVA)

Intervention Type: PROCEDURE

Seal off blood supply to the middle meningeal artery to prevent growth of subdural hematoma

Embolization + Evacuation

Participant receives standard of care evacuation and then undergoes MMA embolization

Middle Meningeal Artery Embolization with polyvinyl alcohol particles (PVA)

Intervention Type: PROCEDURE

Seal off blood supply to the middle meningeal artery to prevent growth of subdural hematoma

Drainage of Subdural Hematoma

Intervention Type: PROCEDURE

Drainage of subdural hematoma via burrhole or craniotomy

Medical Management

Historical control of medically managed patients

No interventions assigned to this group

Surgical Patients

Historical control of patients receiving standard surgery alone

Drainage of Subdural Hematoma

Intervention Type: PROCEDURE

Drainage of subdural hematoma via burrhole or craniotomy

Interventions

Middle Meningeal Artery Embolization with polyvinyl alcohol particles (PVA)

Seal off blood supply to the middle meningeal artery to prevent growth of subdural hematoma

Intervention Type: PROCEDURE

Drainage of Subdural Hematoma

Drainage of subdural hematoma via burrhole or craniotomy

Intervention Type: PROCEDURE

Other Intervention Names

MMA Embolization with polyvinyl alcohol (PVA) particles; Burr Hole Drainage; Craniotomy

Eligibility Criteria

Inclusion Criteria

• Patients 18 years or older undergoing treatment for a new diagnosis of chronic subdural hematoma (cSDH) or
• Patients 18 year or older who have undergone surgical evacuation of a subdural hematoma and have a significant residual hematoma status post-surgery or who develop a recurrent subdural hematoma.

and

• Minimal symptoms such as headache, altered mental status, or mild neurological deficit only
• Ability to understand and sign written informed consent by patient or LAR

Exclusion Criteria

• Significant midline shift and/or neurologic symptoms requiring urgent decompression.
• Common carotid stenosis of over 50%.
• Significant contraindication to angiography (eg. kidney failure, difficult anatomy).
• SDH related to underlying condition
• Acute SDH

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

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joshua W Osbun, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University School of Medicine

St Louis, Missouri, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

201905146

Identifier Type: -

Identifier Source: org_study_id