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

Chronic Subdural Hematoma Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04095819
• Other study ID #: AtlanticHS
• Status: Recruiting
• Phase: N/A
• Start date: June 19, 2019
• Est. completion date: April 19, 2022

Study information

• Verified date: September 2019
• Source: Atlantic Health System
• Contact: Benitez
• Phone: 973-285-7800
• Email: rbenitez[@]ansdocs.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: April 19, 2022
• Est. primary completion date: April 19, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Subdural Hematoma
• Hematoma
• Hematoma, Subdural, Chronic

Intervention

Procedure:
• Middle Meningeal Artery procedure
Seal off the blood supply to the middle meningeal artery to prevent growth of the Subdural Hematoma
• Traditional Surgery
Drainage of Subdural Hematoma using Craniotomy or Burr Hole

Locations

Country	Name	City	State
United States	Overlook Medical Center	Summit	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Atlantic Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in size of SDH	Changes in size of SDH will be recorded in maximum diameter within 6 months.	6 months
Secondary	Change in Neurological status	Changes in Neurological status after the procedure and through study completion	6 months