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

Last updated: September 17, 2019
Sponsor: Atlantic Health System
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT04095819
AtlanticHS
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 brainimaging, as documented by an

  • One or more symptoms attributable to chronic SDH including headache cognitiveimpairment, gait instability, seizure, or mild focal neurologic deficit.

  • In opinion of Investigator or the subject's referring physician, the subject hasfailed conservative management.

Exclusion

Exclusion Criteria:

  • The Subdural hematoma is causing mass effect significant enough to cause marked orprogressive neurologic impairment

  • Any requirement for urgent surgical evacuation is necessary

  • Life expectancy is less than 6 months in the opinion of the subject's primaryphysician

  • Markedly tortuous vasculature precluding safe endovascular access, as assessed onangiogram

  • Acute subdural hematomas

  • Health insurance doesn't cover MMA embolization or performing Surgeon and follow upvisits are considered out of network.

  • Pregnancy

Study Design

Total Participants: 50
Study Start date:
June 19, 2019
Estimated Completion Date:
April 19, 2022

Study 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).

Connect with a study center

  • Overlook Medical Center

    Summit, New Jersey 07901
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.