Middle Meningeal Artery Embolization for Chronic Subdural Hematoma

Middle Meningeal Artery (MMA) Embolization for Patients With Chronic Subdural Hematoma (cSDH)

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Subdural Hematoma
• Intervention / Treatment: Procedure: Middle Meningeal Artery Embolization with polyvinyl alcohol particles (PVA); Procedure: Drainage of Subdural Hematoma

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.

• Study Type: Interventional
• Enrollment (Anticipated): 600
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63108
      • Recruiting
      • Washington University School of Medicine
      • Contact: Brigette Vaughn, BA; Phone Number: 314-273-0368; Email: b.vaughn@wustl.edu
      • Principal Investigator: Joshua W Osbun, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Embolization Only; Medically managed patient receives middle meningeal artery embolization	Procedure: Middle Meningeal Artery Embolization with polyvinyl alcohol particles (PVA); Seal off blood supply to the middle meningeal artery to prevent growth of subdural hematoma; Other Names: MMA Embolization with polyvinyl alcohol (PVA) particles
Experimental: Embolization + Evacuation; Participant receives standard of care evacuation and then undergoes MMA embolization	Procedure: Middle Meningeal Artery Embolization with polyvinyl alcohol particles (PVA); Seal off blood supply to the middle meningeal artery to prevent growth of subdural hematoma; Other Names: MMA Embolization with polyvinyl alcohol (PVA) particles; Procedure: Drainage of Subdural Hematoma; Drainage of subdural hematoma via burrhole or craniotomy; Other Names: Burr Hole Drainage; Craniotomy
No Intervention: Medical Management; Historical control of medically managed patients
Active Comparator: Surgical Patients; Historical control of patients receiving standard surgery alone	Procedure: Drainage of Subdural Hematoma; Drainage of subdural hematoma via burrhole or craniotomy; Other Names: Burr Hole Drainage; Craniotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with recurrent or refractory hematoma (Radiographic resolution)	The subdural hematoma persists or reoccurs	A head CT will be repeated 24 hours after the procedure, 7-10 days, 30 days, and 90 days post procedure to measure any change in size of the SDH compared to pre-procedure size
Number of patients requiring secondary evacuation surgery (Treatment Efficacy)	The participant requires a post-procedure (post-MMA embolization) evacuation of the subdural hematoma due to re-occurrence or persistence of hematoma and symptoms	Evacuation surgery required within the 90 day follow up period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure-related complication rate (Safety)	Complication rate of embolization procedure vs surgery	Procedure-related complications will be compared between embolization and historical surgical patients assessed through study completion, 90 days
Change in NIH Stroke Scale Score (Functional outcome)	Change in score on National Institutes of Health Stroke Scale. The NIH Stroke Scale is used to quantify neurologic impairments. It consists of 11 items each scored between 0 and 4 points. The maximum score is 42, indicating severe impairment, and the minimum score is 0. Stroke severity 0 No stroke symptoms 1-4 Minor stroke 5-15 Moderate stroke 16-20 Moderate to severe stroke 21-42 Severe stroke	Compared pre-procedure, 24 hours post-procedure, 7-10 days, 30 days, and 90 days post-procedure
Change in modified Rankin Scale (Functional outcome)	Change in score on modified Rankin Scale The modified Rankin Scale (mRS) measures the degree of disability or dependence after a stroke or other neurologic disease. The scale runs from 0-6, with 0 indicating perfect health with no symptoms to 6 indicating death. 0 - No symptoms.; - No significant disability. Able to carry out all usual activities, despite some symptoms.; - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.; - Moderate disability. Requires some help, but able to walk unassisted.; - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.; - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.; - Dead.	Compared pre-procedure, 24 hours post-procedure, 7-10 days, 30 days, and 90 days post-procedure
Change in size of subdural hematoma	CT scan measurements of size of subdural hematoma	Compared pre-procedure, 24 hours post-procedure, 7-10 days, 30 days, and 90 days post-procedure

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Investigators: Principal Investigator: Joshua W Osbun, MD, Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2019
• Primary Completion (Anticipated): August 18, 2024
• Study Completion (Anticipated): January 1, 2025

Study Registration Dates

• First Submitted: August 15, 2019
• First Submitted That Met QC Criteria: August 21, 2019
• First Posted (Actual): August 22, 2019

Study Record Updates

• Last Update Posted (Actual): May 26, 2022
• Last Update Submitted That Met QC Criteria: May 19, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Hemorrhage; Craniocerebral Trauma; Trauma, Nervous System; Intracranial Hemorrhages; Intracranial Hemorrhage, Traumatic; Hematoma; Hematoma, Subdural; Hematoma, Subdural, Chronic; Physiological Effects of Drugs; Anti-Infective Agents, Local; Anti-Infective Agents; Central Nervous System Depressants; Ethanol
• Other Study ID Numbers: 201905146

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No