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

  • STATUS
    Recruiting
  • End date
    Apr 19, 2022
  • participants needed
    50
  • sponsor
    Atlantic Health System
Updated on 23 January 2021

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.

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).

Details
Condition Chronic subdural hematoma
Treatment Middle Meningeal Artery procedure, Traditional Surgery
Clinical Study IdentifierNCT04095819
SponsorAtlantic Health System
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

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
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