Dartmouth Middle Meningeal Embolization Trial (DaMMET)

NCT04270955 | Completed

• 1 other identifier: D20037
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Subdural Hematoma; Chronic Subdural Hematoma; Intracranial Hemorrhage

Outcome Measures

Primary Outcomes (3)

• Radiographic resolution of hematoma

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

  3 months post-procedure

• 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

• 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 Outcomes (6)

• Symptomatic improvement

  3 month follow up appointment

• Symptomatic improvement

  6 month follow up appointment

• Symptomatic improvement

  12 month follow up appointment

• NIH Stroke Scale

  3 months

• NIH Stroke Scale

  6 months

Study Arms (4)

Symptomatic, standard of care

ACTIVE COMPARATOR

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.

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

Symptomatic, MMA embolization + standard of care

EXPERIMENTAL

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).

Procedure: Embolization of the Middle Meningeal Artery; Procedure: Standard of care including possible surgical evacuation of subdural hematoma

Asymptomatic, standard of care

ACTIVE COMPARATOR

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.

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

Asymptomatic, standard of care + MMA embolization

EXPERIMENTAL

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).

Procedure: Embolization of the Middle Meningeal Artery; Procedure: Standard of care including possible surgical evacuation of subdural hematoma

Interventions

Embolization of the Middle Meningeal Artery PROCEDURE

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.

Asymptomatic, standard of care + MMA embolization; Symptomatic, MMA embolization + standard of care

Standard of care including possible surgical evacuation of subdural hematoma PROCEDURE

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

Asymptomatic, standard of care; Asymptomatic, standard of care + MMA embolization; Symptomatic, MMA embolization + standard of care; Symptomatic, standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Conditions

Hematoma, Subdural, Chronic; Hematoma, Subdural; Intracranial Hemorrhages

Condition Hierarchy (Ancestors)

Intracranial Hemorrhage, Traumatic; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Vascular Diseases; Cardiovascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematoma; Hemorrhage; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Interventional Neuroradiology

Study Record Dates

• First Submitted: February 8, 2020
• First Posted: February 17, 2020
• Study Start: March 11, 2020
• Primary Completion: January 11, 2024
• Study Completion: January 11, 2024
• Last Updated: February 22, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)