Middle Meningeal Artery Embolization for Chronic Subdural Hematoma

• ClinicalTrials.gov Identifier: NCT04065113
• Recruitment Status: Recruiting
• First Posted: August 22, 2019
• Last Update Posted: September 24, 2019
• Sponsor: Washington University School of Medicine
• Information provided by (Responsible Party): Osbun, Washington University School of Medicine

Tracking Information

• First Submitted Date: August 15, 2019
• First Posted Date: August 22, 2019
• Last Update Posted Date: September 24, 2019
• Actual Study Start Date: September 19, 2019
• Estimated Primary Completion Date: August 18, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 21, 2019)

• Number of patients with recurrent or refractory hematoma (Radiographic resolution) [ Time Frame: 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 ]
  The subdural hematoma persists or reoccurs
• Number of patients requiring secondary evacuation surgery (Treatment Efficacy) [ Time Frame: Evacuation surgery required within the 90 day follow up period ]
  The participant requires a post-procedure (post-MMA embolization) evacuation of the subdural hematoma due to re-occurrence or persistence of hematoma and symptoms

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 21, 2019)

• Procedure-related complication rate (Safety) [ Time Frame: Procedure-related complications will be compared between embolization and historical surgical patients assessed through study completion, 90 days ]
  Complication rate of embolization procedure vs surgery
• Change in NIH Stroke Scale Score (Functional outcome) [ Time Frame: Compared pre-procedure, 24 hours post-procedure, 7-10 days, 30 days, and 90 days post-procedure ]
  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
• Change in modified Rankin Scale (Functional outcome) [ Time Frame: Compared pre-procedure, 24 hours post-procedure, 7-10 days, 30 days, and 90 days post-procedure ]
  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.

  1. - No significant disability. Able to carry out all usual activities, despite some symptoms.
  2. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
  3. - Moderate disability. Requires some help, but able to walk unassisted.
  4. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
  5. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
  6. - Dead.
• Change in size of subdural hematoma [ Time Frame: Compared pre-procedure, 24 hours post-procedure, 7-10 days, 30 days, and 90 days post-procedure ]
  CT scan measurements of size of subdural hematoma

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Middle Meningeal Artery Embolization for Chronic Subdural Hematoma
• Official Title: Middle Meningeal Artery (MMA) Embolization for Patients With Chronic Subdural Hematoma (cSDH)
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Chronic Subdural Hematoma

Intervention

• 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 Name: 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

Study Arms

• Experimental: Embolization Only
  Medically managed patient receives middle meningeal artery embolization
  Intervention: Procedure: Middle Meningeal Artery Embolization with polyvinyl alcohol particles (PVA)
• Experimental: Embolization + Evacuation
  Participant receives standard of care evacuation and then undergoes MMA embolization
  Interventions:

  • Procedure: Middle Meningeal Artery Embolization with polyvinyl alcohol particles (PVA)
  • Procedure: Drainage of Subdural Hematoma
• No Intervention: Medical Management
  Historical control of medically managed patients
• Active Comparator: Surgical Patients
  Historical control of patients receiving standard surgery alone
  Intervention: Procedure: Drainage of Subdural Hematoma

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: August 21, 2019): 600
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: January 1, 2022
• Estimated Primary Completion Date: August 18, 2021 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04065113
• Other Study ID Numbers: 201905146
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: Yes

• Responsible Party: Osbun, Washington University School of Medicine
• Study Sponsor: Washington University School of Medicine
• Collaborators: Not Provided

Investigators

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

• PRS Account: Washington University School of Medicine
• Verification Date: September 2019