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Dartmouth Middle Meningeal Embolization Trial (DaMMET)

NCT04270955 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-02-22

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Dartmouth-Hitchcock Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-11
Primary Completion
2024-01-11
Completion
2024-01-11

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04270955 on ClinicalTrials.gov