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

Sponsor

Atlantic Health System (Other)

Overall Status

Unknown status

CT.gov ID

NCT04095819

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Subdural Hematoma	Procedure: Middle Meningeal Artery procedure Procedure: Traditional Surgery	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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)

Actual Study Start Date :

Jun 19, 2019

Anticipated Primary Completion Date :

Apr 19, 2022

Anticipated Study Completion Date :

Apr 19, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Middle Meningeal Artery Embolization 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

Arm

Intervention/Treatment

Experimental: Middle Meningeal Artery Embolization

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

Outcome Measures

Primary Outcome Measures

Change in size of SDH [6 months]
Changes in size of SDH will be recorded in maximum diameter within 6 months.

Secondary Outcome Measures

Change in Neurological status [6 months]
Changes in Neurological status after the procedure and through study completion

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Overlook Medical Center	Summit	New Jersey	United States	07901

Sponsors and Collaborators

Atlantic Health System

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ronald Benitez, MD, Director of Endovascular Surgery, Atlantic Health System

ClinicalTrials.gov Identifier:

NCT04095819

Other Study ID Numbers:

AtlanticHS

First Posted:

Sep 19, 2019

Last Update Posted:

Sep 19, 2019

Last Verified:

Sep 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hematoma, Subdural

Hematoma, Subdural, Chronic

Hematoma

Study Results

No Results Posted as of Sep 19, 2019