Clinical trial NCT04065113: Middle Meningeal Artery Embolization for Chronic Subdural Hematoma
Official title: Middle Meningeal Artery (MMA) Embolization for Patients With Chronic Subdural Hematoma (cSDH)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Subdural Hematoma
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2019-08-22
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Endovascular middle meningeal artery (MMA) embolization is an emerging treatment for chronic subdural hematoma (cSDH). There is preliminary data to suggest that this minimally invasive therapy may be more efficacious and equally as safe compared to conventional, more invasive surgery. This study seeks to assess the safety and efficacy of middle meningeal artery embolization for chronic subdural hematoma as an adjunct to standard treatments, which include medical management and surgical evacuation.

Detailed description: This study seeks to assess the safety and efficacy of middle meningeal artery embolization for chronic subdural hematoma in addition to standard treatments, which include close observation and surgical evacuation. Middle meningeal artery embolization has emerged recently as a minimally invasive and successful method of preventing re-accumulation of subdural hematoma, particularly for patients that are not obvious surgical candidates or those with recurrent or refractory hematomas. The outcomes of these two groups of patients who undergo middle meningeal artery embolization will be compared to matched historical controls.

Middle meningeal artery embolization is a minimally invasive angiography procedure completed with use of fluoroscopy. Access is obtained through the femoral or radial artery and a catheter is advanced to the MMA. Polyvinyl alcohol particles are then injected to seal off this portion of the artery and prevent any further blood flow into the subdural hematoma. Hemostasis is obtained at the access site and the patient is observed for 24-48 hours on a neurological care unit before discharge.

A head CT, NIHSS, and modified Rankin Score will be repeated on the following schedule: • Pre-Procedure

* 24 hours post procedure
* 7-10 days post procedure
* 30 days post procedure
* 90 days post procedure

Patients with chronic subdural hematoma undergo CT scans and neurologic assessments on hospital admission, as well as follow up CT scans and neurologic assessments to assess for any change in neurologic status or hematoma size. This study utilizes a standard of care follow up schedule to avoid exposing participants to extra radiation. Participants will be followed for study related purposes for 90 days.

Eligibility criteria: Inclusion Criteria:

* Patients 18 years or older undergoing treatment for a new diagnosis of chronic subdural hematoma (cSDH) or
* Patients 18 year or older who have undergone surgical evacuation of a subdural hematoma and have a significant residual hematoma status post-surgery or who develop a recurrent subdural hematoma.

and

* Minimal symptoms such as headache, altered mental status, or mild neurological deficit only
* Ability to understand and sign written informed consent by patient or LAR

Exclusion Criteria:

* Significant midline shift and/or neurologic symptoms requiring urgent decompression.
* Common carotid stenosis of over 50%.
* Significant contraindication to angiography (eg. kidney failure, difficult anatomy).
* SDH related to underlying condition
* Acute SDH

Primary outcomes:
measure: Number of patients with recurrent or refractory hematoma (Radiographic resolution)
timeFrame: A head CT will be repeated 24 hours after the procedure, 7-10 days, 30 days, and 90 days post procedure to measure any change in size of the SDH compared to pre-procedure size
measure: Number of patients requiring secondary evacuation surgery (Treatment Efficacy)
timeFrame: Evacuation surgery required within the 90 day follow up period
Secondary outcomes:
measure: Procedure-related complication rate (Safety)
timeFrame: Procedure-related complications will be compared between embolization and historical surgical patients assessed through study completion, 90 days
measure: Change in NIH Stroke Scale Score (Functional outcome)
timeFrame: Compared pre-procedure, 24 hours post-procedure, 7-10 days, 30 days, and 90 days post-procedure
measure: Change in modified Rankin Scale (Functional outcome)
timeFrame: Compared pre-procedure, 24 hours post-procedure, 7-10 days, 30 days, and 90 days post-procedure
measure: Change in size of subdural hematoma
timeFrame: Compared pre-procedure, 24 hours post-procedure, 7-10 days, 30 days, and 90 days post-procedure
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Joshua W Osbun, MD
role: PRINCIPAL_INVESTIGATOR
References: