Dartmouth Middle Meningeal Embolization Trial (DaMMET)

Chronic Subdural Hematoma Clinical Trial

— DAMMET  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04270955
• Other study ID #: D20037
• Status: Completed
• Phase: N/A
• Start date: March 11, 2020
• Est. completion date: January 11, 2024

Study information

• Verified date: February 2024
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 11, 2024
• Est. primary completion date: January 11, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age or older

• Have radiographic imaging showing a cSDH > 7mm in maximal thickness encompassing > 50% of the convexity (non-focal).

• Capable of giving consent for the procedure or have an acceptable surrogate capable of giving consent on the subject's behalf

Exclusion Criteria:

• The cSDH is secondary to an underlying vascular malformation, tumor, cyst, spontaneous cerebrospinal fluid hypotension or previous craniotomy

• Life expectancy < 6 months

• Vascular anatomy that puts the patient at high risk for adverse events (e.g. critical carotid stenosis, abnormal external-internal carotid circulation)

• Incapable of being reasonably expected to be able to attend follow-up appointments at Dartmouth-Hitchcock Medical Center

• Vulnerable patients including homeless patients, incarcerated patients and mentally ill patients without appropriate medical decision-making proxy that the physician believes are incapable of appropriately assessing the risks of the procedure

Related Conditions & MeSH terms

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

Intervention

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.
• 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

Locations

Country	Name	City	State
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiographic resolution of hematoma	CT scan to evaluate for residual hematoma, comparing baseline to 3 months	3 months post-procedure
Primary	Radiographic resolution of hematoma	CT scan to evaluate for residual hematoma, comparing baseline to 6 months. Can be canceled if cSDH is completely resolved at 3 months	6 months post-procedure
Primary	Radiographic resolution of hematoma	CT scan to evaluate for residual hematoma, comparing baseline to 12 months. Can be canceled if cSDH is completely resolved at 3 or 6 months	12 months post-procedure
Secondary	Symptomatic improvement	HPI and neurologic exam (standard clinic follow-up) to compare to presenting symptoms.	3 month follow up appointment
Secondary	Symptomatic improvement	HPI and neurologic exam (standard clinic follow-up) to compare to presenting symptoms. This may be canceled if the symptoms and hematoma are completely resolved at 3 months	6 month follow up appointment
Secondary	Symptomatic improvement	HPI and neurologic exam (standard clinic follow-up) to compare to presenting symptoms. This may be canceled if the symptoms and hematoma are completely resolved at 3 or 6 months	12 month follow up appointment
Secondary	NIH Stroke Scale	Comparison of NIHSS at admission to 3 month follow-up	3 months
Secondary	NIH Stroke Scale	Comparison of NIHSS at admission to 6 month follow-up. May be canceled if cSDH resolved by 3 month follow up	6 months
Secondary	NIH Stroke Scale	Comparison of NIHSS at admission to 12 month follow-up. May be canceled if cSDH resolved by 3 or 6 month follow up	6 months