Chronic Subdural Hematoma Treatment With Avastin® (Bevacizumab) Intra-Arterial Injection: A Non-Randomized, Open-Label Phase 1/2 Clinical Trial
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Adult patients (≥18 years)
• Radiographic evidence of chronic subdural hematoma, including
‣ Persistence of subdural blood more than 10 days after index traumatic injury or event
⁃ Presence of mixed density blood
⁃ Presence of subdural membranes
• Can obtain informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization.
Locations
United States
New Jersey
Cooper University Health Care
RECRUITING
Camden
Time Frame
Start Date: 2024-06-17
Estimated Completion Date: 2028-06
Participants
Target number of participants: 140
Treatments
Experimental: Phase 1 Unilateral cSDH/ 2mg/kg Arm
During phase 1, single 2mg/kg dose of bevacizumab to treat unilateral cSDH
Experimental: Phase 1 Bilateral cSDH/ 4mg/kg Arm
During phase 1, two 2mg/kg doses (cumulatively 4mg/kg) of bevacizumab to treat bilateral cSDH
Experimental: Phase 2 Unilateral cSDH/ 2mg/kg Arm
During phase 2, single 2mg/kg dose of bevacizumab to treat unilateral cSDH
Experimental: Phase 2 Bilateral cSDH/ 4mg/kg Arm
During phase 2, two 2mg/kg doses (cumulatively 4mg/kg) of bevacizumab to treat bilateral cSDH
Related Therapeutic Areas
Sponsors
Collaborators: Society of Vascular and Interventional Neurology
Leads: The Cooper Health System