Chronic Subdural Hematoma, Subdural Hematoma
Conditions
Keywords
Subdural Hematoma, Chronic Subdural Hematoma, Intracranial Hemorrhage
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.
Interventions
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.
PROCEDUREStandard 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
Sponsors
Dartmouth-Hitchcock Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic resolution of hematoma | 3 months post-procedure | CT scan to evaluate for residual hematoma, comparing baseline to 3 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Symptomatic improvement | 3 month follow up appointment | HPI and neurologic exam (standard clinic follow-up) to compare to presenting symptoms. |
| NIH Stroke Scale | 3 months | Comparison of NIHSS at admission to 3 month follow-up |
Countries
United States
Outcome results
None listed