Chronic Subdural Hematoma Treatment With Avastin® (Bevacizumab) Intra-Arterial Injection: A Non-Randomized, Open-Label Phase 1/2 Clinical Trial
The Cooper Health System
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?
Eligibility
- Age range
- 18+ years
- Sex
- All
- 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., in…
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
Location
- Cooper University Health CareCamden, New Jersey