NCT04270955

Dartmouth Middle Meningeal Embolization Trial (DaMMET)

A Single Center Randomized Control Trial to Evaluate the Efficacy of Middle Meningeal Artery Embolization in the Treatment of Chronic Subdural Hematomas

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Dartmouth-Hitchcock Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Chronic subdural hematomas (cSDH) are one form of bleeding in the head. They are one of the most common diseases encountered by neurosurgeons across the country. The cSDH can push on the brain and produce symptoms that include seizures, weakness, loss of sensation, and confusion. Many of these cSDH produce repetitive bleeding. Treatment has largely consisted of surgical drainage of hematoma (also known as a blood clot) through either a small hole in the skull or open surgery. However, it is common for the cSDH to reappear despite these procedures. A recent study has shown a treatment failure rate of 27% and a need for additional surgery at 19%. A new approach to treatment of cSDH blocks the blood supply to the tissue that produces the repeated bleeding. Catheters are used to gain access to the middle meningeal artery (MMA), an artery that supplies the coverings of the brain. The artery is blocked using small particles or glue in a process called embolization. A recent pilot study of 72 patients who underwent MMA embolization showed a much lower rate of repeated bleeding. Based on these results, it is thought that this procedure holds promise in reducing the number of cSDH that require one or more operations. The goal of this study is to systematically examine if blocking the blood supply to the tissue responsible for repeated bleeding helps the cSDH resolve and improves patient outcomes.

Conditions

• Chronic Subdural Hematoma
• Subdural Hematoma

Interventions

Type	Name	Description
PROCEDURE	Embolization of the Middle Meningeal Artery	Using established endovascular techniques and materials patient will have a diagnostic catheter based angiogram performed on the side(s) of the brain where the subdural hematoma is present. After verifying the vascular anatomy to ensure safety of the procedure the Middle Meningeal Artery will be embolized.
PROCEDURE	Standard of care including possible surgical evacuation of subdural hematoma	Standard of care could include observation or intervention including surgical drainage of subdural hematoma by bedside drain, Subdural Evacuating Port System (SEPS), burr hole or craniotomy

Timeline

• Start date: 2020-03-11
• Primary completion: 2024-01-11
• Completion: 2024-01-11
• First posted: 2020-02-17
• Last updated: 2024-02-22

Locations

1 site across 1 country: United States