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Middle Meningeal Artery (MMA) Embolization Compared to Traditional Surgical Strategies to Treat Chronic Subdural Hematomas (cSDH)

Primary Purpose

Chronic Subdural Hematoma

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Middle Meningeal Artery procedure
Traditional Surgery
Sponsored by
Atlantic Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Subdural Hematoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18 or older
  • Participant or Surrogate must be English speaking
  • Subjects must have a diagnosis of chronic or acute-on subdural hematoma based on brain imaging, as documented by an
  • One or more symptoms attributable to chronic SDH including headache cognitive impairment, gait instability, seizure, or mild focal neurologic deficit.
  • In opinion of Investigator or the subject's referring physician, the subject has failed conservative management.

Exclusion Criteria:

  • The Subdural hematoma is causing mass effect significant enough to cause marked or progressive neurologic impairment
  • Any requirement for urgent surgical evacuation is necessary
  • Life expectancy is less than 6 months in the opinion of the subject's primary physician
  • Markedly tortuous vasculature precluding safe endovascular access, as assessed on angiogram
  • Acute subdural hematomas
  • Health insurance doesn't cover MMA embolization or performing Surgeon and follow up visits are considered out of network.
  • Pregnancy

Sites / Locations

  • Overlook Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Middle Meningeal Artery Embolization

Traditional Surgery

Arm Description

Middle Meningeal Artery Embolization

Craniotomy/Burr hole

Outcomes

Primary Outcome Measures

Change in size of SDH
Changes in size of SDH will be recorded in maximum diameter within 6 months.

Secondary Outcome Measures

Change in Neurological status
Changes in Neurological status after the procedure and through study completion

Full Information

First Posted
September 9, 2019
Last Updated
September 17, 2019
Sponsor
Atlantic Health System
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1. Study Identification

Unique Protocol Identification Number
NCT04095819
Brief Title
Middle Meningeal Artery (MMA) Embolization Compared to Traditional Surgical Strategies to Treat Chronic Subdural Hematomas (cSDH)
Official Title
Pilot Study to Evaluate Safety of and Efficacy of Middle Meningeal Artery (MMA) Embolization Compared to Traditional Surgical Strategies to Treat Chronic Subdural Hematomas (cSDH)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 19, 2019 (Actual)
Primary Completion Date
April 19, 2022 (Anticipated)
Study Completion Date
April 19, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Atlantic Health System

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Chronic Subdural Hematoma (cSDH) is a common hematologic problem particularly in older patients. The purpose of this study is to evaluate the safety and efficacy of middle meningeal artery (MMA) embolization compared to traditional surgical strategies for patients presenting with chronic subdural hematoma (cSDH). Although MMA embolization is minimally-invasive procedure that is routinely used for the treatment of tumors or vascular formations (1), this study investigates the use of an established procedure for a new disease state.
Detailed Description
The purpose of the research study is to evaluate the safety and efficacy of a new, less-invasive procedure to treat chronic subdural hematoma (cSDH). A subdural hematoma occurs when blood collects on the brain's surface beneath the skull. Subdural hematomas can be life-threatening. They usually result from a head injury. This study will compare the new procedure to conventional surgical treatment of chronic subdural hematoma (cSDH). The new procedure is called middle meningeal artery embolization (MMA). Current or conventional treatment of chronic subdural hematoma (cSDH) involves surgery (burr hole drainage and craniotomy) to access and remove the cause of the bleeding that is causing the subdural hematoma. The new procedure, MMA embolization, involves guiding a catheter that is inserted into a blood vessel to the area of the brain that is supplying blood to the subdural hematoma. Particles or a special type of glue will be released to stop the bleeding that is causing the subdural hematoma. This technique has been used to treat other brain conditions, for example, (to treat tumors or malformation of blood vessels).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Subdural Hematoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Middle Meningeal Artery Embolization
Arm Type
Experimental
Arm Description
Middle Meningeal Artery Embolization
Arm Title
Traditional Surgery
Arm Type
Active Comparator
Arm Description
Craniotomy/Burr hole
Intervention Type
Procedure
Intervention Name(s)
Middle Meningeal Artery procedure
Intervention Description
Seal off the blood supply to the middle meningeal artery to prevent growth of the Subdural Hematoma
Intervention Type
Procedure
Intervention Name(s)
Traditional Surgery
Intervention Description
Drainage of Subdural Hematoma using Craniotomy or Burr Hole
Primary Outcome Measure Information:
Title
Change in size of SDH
Description
Changes in size of SDH will be recorded in maximum diameter within 6 months.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change in Neurological status
Description
Changes in Neurological status after the procedure and through study completion
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 or older Participant or Surrogate must be English speaking Subjects must have a diagnosis of chronic or acute-on subdural hematoma based on brain imaging, as documented by an One or more symptoms attributable to chronic SDH including headache cognitive impairment, gait instability, seizure, or mild focal neurologic deficit. In opinion of Investigator or the subject's referring physician, the subject has failed conservative management. Exclusion Criteria: The Subdural hematoma is causing mass effect significant enough to cause marked or progressive neurologic impairment Any requirement for urgent surgical evacuation is necessary Life expectancy is less than 6 months in the opinion of the subject's primary physician Markedly tortuous vasculature precluding safe endovascular access, as assessed on angiogram Acute subdural hematomas Health insurance doesn't cover MMA embolization or performing Surgeon and follow up visits are considered out of network. Pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Benitez
Phone
973-285-7800
Email
rbenitez@ansdocs.com
First Name & Middle Initial & Last Name or Official Title & Degree
Elena Lobur, RN
Phone
908-522-2045
Email
elena.lobur@atlantichealth.org
Facility Information:
Facility Name
Overlook Medical Center
City
Summit
State/Province
New Jersey
ZIP/Postal Code
07901
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ron Benitez, MD
Phone
973-285-7800
Email
rebenitez@ansdocs.com
First Name & Middle Initial & Last Name & Degree
Elena Lobur, RN
Phone
908-522-2045
Email
elena.lobur@atlantichealth.org

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36129273
Citation
Fuentes AM, Khalid SI, Mehta AI. Predictors of Subsequent Intervention After Middle Meningeal Artery Embolization for Treatment of Subdural Hematoma: A Nationwide Analysis. Neurosurgery. 2023 Jan 1;92(1):144-149. doi: 10.1227/neu.0000000000002151. Epub 2022 Sep 21.
Results Reference
derived

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Middle Meningeal Artery (MMA) Embolization Compared to Traditional Surgical Strategies to Treat Chronic Subdural Hematomas (cSDH)

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