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Middle Meningeal Artery Embolization for Chronic Subdural Hematoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04065113
Recruitment Status : Recruiting
First Posted : August 22, 2019
Last Update Posted : September 24, 2019
Sponsor:
Information provided by (Responsible Party):
Osbun, Washington University School of Medicine

Study Description
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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.

Condition or disease Intervention/treatment Phase
Chronic Subdural Hematoma Procedure: Middle Meningeal Artery Embolization with polyvinyl alcohol particles (PVA) Procedure: Drainage of Subdural Hematoma Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Middle Meningeal Artery (MMA) Embolization for Patients With Chronic Subdural Hematoma (cSDH)
Actual Study Start Date : September 19, 2019
Estimated Primary Completion Date : August 18, 2021
Estimated Study Completion Date : January 1, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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 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
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


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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


  3. 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.

  4. 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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04065113


Locations
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United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63108
Contact: Christina Moore, RN    314-273-0368    cmmoore@wustl.edu   
Principal Investigator: Joshua W Osbun, MD         
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Joshua W Osbun, MD Washington University School of Medicine
More Information
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Responsible Party: Osbun, Assistant Professor, Neurosurgery, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT04065113    
Other Study ID Numbers: 201905146
First Posted: August 22, 2019    Key Record Dates
Last Update Posted: September 24, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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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
Additional relevant MeSH terms:
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Hematoma, Subdural
Hematoma, Subdural, Chronic
Hematoma
Hemorrhage
Pathologic Processes
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
Wounds and Injuries
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs