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

Atlantic Health System

Status: Unknown

Conditions: Chronic Subdural Hematoma

Treatments: Procedure: Traditional Surgery; Procedure: Middle Meningeal Artery procedure

Study type: Interventional

Funder types: Other

Identifiers

NCT04095819

AtlanticHS

Details and patient eligibility

About

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.

Full 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).

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Middle Meningeal Artery Embolization

Experimental group

Description:

Middle Meningeal Artery Embolization

Treatment:

Procedure: Middle Meningeal Artery procedure

Traditional Surgery

Active Comparator group

Description:

Craniotomy/Burr hole

Treatment:

Procedure: Traditional Surgery