Dartmouth Middle Meningeal Embolization Trial (DaMMET)

Overview

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.

Full Title of Study: “A Single Center Randomized Control Trial to Evaluate the Efficacy of Middle Meningeal Artery Embolization in the Treatment of Chronic Subdural Hematomas”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2021

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

Arms, Groups and Cohorts

  • 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).

Clinical Trial Outcome Measures

Primary Measures

  • Radiographic resolution of hematoma
    • Time Frame: 3 months post-procedure
    • CT scan to evaluate for residual hematoma, comparing baseline to 3 months
  • Radiographic resolution of hematoma
    • Time Frame: 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
  • Radiographic resolution of hematoma
    • Time Frame: 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 Measures

  • Symptomatic improvement
    • Time Frame: 3 month follow up appointment
    • HPI and neurologic exam (standard clinic follow-up) to compare to presenting symptoms.
  • Symptomatic improvement
    • Time Frame: 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
  • Symptomatic improvement
    • Time Frame: 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
  • NIH Stroke Scale
    • Time Frame: 3 months
    • Comparison of NIHSS at admission to 3 month follow-up
  • NIH Stroke Scale
    • Time Frame: 6 months
    • Comparison of NIHSS at admission to 6 month follow-up. May be canceled if cSDH resolved by 3 month follow up
  • NIH Stroke Scale
    • Time Frame: 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Dartmouth-Hitchcock Medical Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Daniel R. Calnan, Chief Resident and Cerebrovascular Fellow, Neurosurgery – Dartmouth-Hitchcock Medical Center
  • Overall Contact(s)
    • Daniel R Calnan, MD/PhD, 6036505109, daniel.r.calnan@hitchcock.org

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