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?
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
140
Single 2mg/kg dose of bevacizumab to treat unilateral cSDH
Two 2mg/kg doses (cumulatively 4mg/kg) of bevacizumab to treat bilateral cSDH
Cooper University Health Care
Camden, New Jersey, United States
RECRUITINGNumber of Participants with Serious Adverse Events
Reported serious adverse events classified using MedDRA and CTCAE, in addition to treatment-related events and all other adverse events
Time frame: Up to 3 months after study treatment
Rate of Hematoma Recurrence
Rate of hematoma recurrence or progression requiring intervention and/or readmission
Time frame: 3 months after study treatment and 6 months after study treatment
Rate of Complete Hematoma Resolution
Rate of complete hematoma resolution compared to baseline on imaging
Time frame: 3 months after study treatment and 6 months after study treatment
Rate of Partial Hematoma Resolution
Rate of at least 50% or greater reduction in hematoma size from baseline on imaging
Time frame: 3 months after study treatment and 6 months after study treatment
Change in Hematoma Size
Change in hematoma size measured in millimeters on imaging
Time frame: 3 months after study treatment and 6 months after study treatment
Change in Clinical Neurological Symptom Scale Scores: NIHSS
Change in National Institutes of Health Stroke Scale (NIHSS) scores, scores range from 0 to 42, with higher scores indicating more severe neurological deficit
Time frame: 3 months after study treatment and 6 months after study treatment
Change in Clinical Neurological Symptom Scale Scores: GCS
Change in Glasgow Coma Scale (GCS) scores, ranging from 3 to 15 with lower score indicating more impaired consciousness
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Time frame: 3 months after study treatment and 6 months after study treatment
Change in Clinical Neurological Symptom Scale Scores: mRS
Change in modified Rankin Scale (mRS) scores, ranges from 0-6 with higher score indicating worse functional outcome
Time frame: 3 months after study treatment and 6 months after study treatment