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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04270955
Other study ID # D20037
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
See also
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Recruiting NCT05267184 - Swedish Trial on Embolization of Middle Meningeal Artery Versus Surgical Evacuation in Chronic Subdural Hematoma N/A
Not yet recruiting NCT05900557 - Neurologic Deficits and Recovery in Chronic Subdural Hematoma N/A
Completed NCT02757235 - The Swedish Study of Irrigation Fluid Temperature in the Evacuation of Chronic Subdural Hematoma N/A
Terminated NCT02111785 - Dexamethasone Versus Burr Hole Craniostomy for Symptomatic Chronic Subdural Hematoma Phase 2/Phase 3