Chronic Subdural Hematoma
Conditions
Keywords
Chronic subdural hematoma, Chronic intracranial subdural hematoma, Vascular endothelial growth factor, Bevacizumab, Middle meningeal artery embolization
Brief summary
The goal of this clinical trial is to test whether infusing bevacizumab into the middle meningeal arteries can be used to treat chronic subdural hematomas (cSDH). The main questions it aims to answer are: * Is bevacizumab infusion safe in cSDH patients? * Is bevacizumab infusion effective in treating cSDH?
Interventions
DRUGBevacizumab 2 mg/kg
Single 2mg/kg dose of bevacizumab to treat unilateral cSDH
DRUGBevacizumab 4 mg/kg
Two 2mg/kg doses (cumulatively 4mg/kg) of bevacizumab to treat bilateral cSDH
Sponsors
Society of Vascular and Interventional Neurology
The Cooper Health System
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients (≥18 years) * Radiographic evidence of chronic subdural hematoma, including 1. Persistence of subdural blood more than 10 days after index traumatic injury or event 2. Presence of mixed density blood 3. Presence of subdural membranes * Can obtain informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization.
Exclusion criteria
* Pregnant, breastfeeding, or unwilling to practice contraception during participation in the study. * Patients with concomitant intracranial pathology other than subdural hematoma (e.g., intracranial malignancy). * Patients with known hypersensitivity to bevacizumab. * Patients with radiographic evidence of mass effect. * Patients have focal neurological deficits attributed to subdural hematoma. * Patient had craniotomy or burr hole operative procedures performed in preceding two weeks prior to onset of subdural hematoma. * Secondary causes apart from trauma for the chronic subdural hematoma, such as underlying vascular abnormality or tumor. * Emergent surgical evacuation is required for the patient. * Non-convexity chronic subdural hematoma, as the middle meningeal artery will not supply this area. * Coagulation abnormalities, including platelet count \<100,000 and/or international normalized ratio of \<1.5 despite attempts for correction. * Patients with known contraindications for angiography. Patients with contrast allergy will be premedicated with diphenhydramine and steroids. * Patient has known active systemic infection or sepsis. * Patient has contradiction to anesthetic agents used for conscious sedation/monitored anesthesia care (MAC). * Patient has life expectancy of less than six months due to comorbid terminal conditions. * Patient has a premorbid modified Rankin score (mRS) of 5 or greater. * Concurrent participation in another research protocol for investigation of an experimental therapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Serious Adverse Events | Up to 3 months after study treatment | Reported serious adverse events classified using MedDRA and CTCAE, in addition to treatment-related events and all other adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Hematoma Recurrence | 3 months after study treatment and 6 months after study treatment | Rate of hematoma recurrence or progression requiring intervention and/or readmission |
| Rate of Complete Hematoma Resolution | 3 months after study treatment and 6 months after study treatment | Rate of complete hematoma resolution compared to baseline on imaging |
| Rate of Partial Hematoma Resolution | 3 months after study treatment and 6 months after study treatment | Rate of at least 50% or greater reduction in hematoma size from baseline on imaging |
| Change in Clinical Neurological Symptom Scale Scores: NIHSS | 3 months after study treatment and 6 months after study treatment | Change in National Institutes of Health Stroke Scale (NIHSS) scores, scores range from 0 to 42, with higher scores indicating more severe neurological deficit |
| Change in Clinical Neurological Symptom Scale Scores: GCS | 3 months after study treatment and 6 months after study treatment | Change in Glasgow Coma Scale (GCS) scores, ranging from 3 to 15 with lower score indicating more impaired consciousness |
| Change in Clinical Neurological Symptom Scale Scores: mRS | 3 months after study treatment and 6 months after study treatment | Change in modified Rankin Scale (mRS) scores, ranges from 0-6 with higher score indicating worse functional outcome |
| Change in Hematoma Size | 3 months after study treatment and 6 months after study treatment | Change in hematoma size measured in millimeters on imaging |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Anatomical Variants | During the treatment procedure | Middle meningeal arteries with dangerous anastomoses observed on imaging |
Countries
United States
Outcome results
None listed