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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

Tracking Information
First Submitted Date  ICMJE August 15, 2019
First Posted Date  ICMJE August 22, 2019
Last Update Posted Date September 24, 2019
Actual Study Start Date  ICMJE September 19, 2019
Estimated Primary Completion Date August 18, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Middle Meningeal Artery Embolization for Chronic Subdural Hematoma
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Subdural Hematoma
Intervention  ICMJE
  • 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 21, 2019)
600
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 1, 2022
Estimated Primary Completion Date August 18, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04065113
Other Study ID Numbers  ICMJE 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  ICMJE
Plan to Share IPD: Yes
Responsible Party Osbun, Washington University School of Medicine
Study Sponsor  ICMJE Washington University School of Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Joshua W Osbun, MD Washington University School of Medicine
PRS Account Washington University School of Medicine
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP