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

September 17, 2019 updated by: Ronald Benitez, MD, Atlantic Health System

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)

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Middle Meningeal Artery Embolization
Procedure: Middle Meningeal Artery procedure
Seal off the blood supply to the middle meningeal artery to prevent growth of the Subdural Hematoma
Active Comparator: Traditional Surgery
Craniotomy/Burr hole
Procedure: Traditional Surgery
Drainage of Subdural Hematoma using Craniotomy or Burr Hole

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in size of SDH
Time Frame: 6 months
Changes in size of SDH will be recorded in maximum diameter within 6 months.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Neurological status
Time Frame: 6 months
Changes in Neurological status after the procedure and through study completion
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Atlantic Health System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 19, 2019

Primary Completion (Anticipated)

April 19, 2022

Study Completion (Anticipated)

April 19, 2022

Study Registration Dates

First Submitted

September 9, 2019

First Submitted That Met QC Criteria

September 17, 2019

First Posted (Actual)

September 19, 2019

Study Record Updates

Last Update Posted (Actual)

September 19, 2019

Last Update Submitted That Met QC Criteria

September 17, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AtlanticHS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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