Dartmouth Middle Meningeal Embolization Trial (DaMMET)

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StatusRecruiting

Keywords

Abstract

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.

Dates

Last Verified:	02/29/2020
First Submitted:	02/07/2020
Estimated Enrollment Submitted:	02/11/2020
First Posted:	02/16/2020
Last Update Submitted:	03/10/2020
Last Update Posted:	03/12/2020
Actual Study Start Date:	03/10/2020
Estimated Primary Completion Date:	12/30/2021
Estimated Study Completion Date:	12/30/2022

Condition or disease

Chronic Subdural Hematoma

Subdural Hematoma

Intervention/treatment

Procedure: Embolization of the Middle Meningeal Artery

Procedure: Standard of care including possible surgical evacuation of subdural hematoma

Phase

Arm Groups

Arm	Intervention/treatment
Active Comparator: Symptomatic, standard of care Patients in this group will be offered all procedures and care deemed appropriate by the Neurosurgeon in charge of their care. This could include surgical intervention, observation, medical management.
Experimental: Symptomatic, MMA embolization + standard of care Patients in this group will be treated with the standard of care treatment (the same care described in the arm "Symptomatic, standard of care") but will also undergo MMA embolization of the affected side(s).
Active Comparator: Asymptomatic, standard of care Patients in this group will be offered all procedures deemed appropriate by the Neurosurgeon in charge of their care. This could include surgical intervention, observation, medical management.
Experimental: Asymptomatic, standard of care + MMA embolization Patients in this group will be treated with the standard of care treatment (the same care described in the arm "Asymptomatic, standard of care") but will also undergo MMA embolization of the affected side(s).

Eligibility Criteria

Ages Eligible for Study	18 Years To 18 Years
Sexes Eligible for Study	All
Accepts Healthy Volunteers	Yes
Criteria	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

Outcome

Primary Outcome Measures

1. Radiographic resolution of hematoma [3 months post-procedure]

CT scan to evaluate for residual hematoma, comparing baseline to 3 months

2. Radiographic resolution of hematoma [6 months post-procedure]

CT scan to evaluate for residual hematoma, comparing baseline to 6 months. Can be canceled if cSDH is completely resolved at 3 months

3. Radiographic resolution of hematoma [12 months post-procedure]

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

Secondary Outcome Measures

1. Symptomatic improvement [3 month follow up appointment]

HPI and neurologic exam (standard clinic follow-up) to compare to presenting symptoms.

2. Symptomatic improvement [6 month follow up appointment]

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

3. Symptomatic improvement [12 month follow up appointment]

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

4. NIH Stroke Scale [3 months]

Comparison of NIHSS at admission to 3 month follow-up

5. NIH Stroke Scale [6 months]

Comparison of NIHSS at admission to 6 month follow-up. May be canceled if cSDH resolved by 3 month follow up

6. NIH Stroke Scale [6 months]

Comparison of NIHSS at admission to 12 month follow-up. May be canceled if cSDH resolved by 3 or 6 month follow up

Dartmouth Middle Meningeal Embolization Trial (DaMMET)

Keywords

asthenia

hematoma

hemorrhage

seizures

thrombosis