Chronic Subdural Hematoma Treatment With Intra-Arterial Bevacizumab Injection
NCT Number: NCT06510582
Acronym: CHAI
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Chronic Subdural Hematoma
Interventions: DRUG: Bevacizumab 2 mg/kg|DRUG: Bevacizumab 4 mg/kg
Sponsor: The Cooper Health System
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 140
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-17
Completion Date: 2028-06-17
Locations: Cooper University Health Care, Camden, New Jersey, 08103, United States

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?

Primary Outcome Measures: Number 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, Screening to end of study follow-up at 1 year
Secondary Outcome Measures: Rate of Hematoma Recurrence, Rate of hematoma recurrence or progression requiring intervention and/or readmission, 3-month follow-up; End of study at 1 year|Rate of Complete Hematoma Resolution, Rate of complete hematoma resolution compared to baseline on imaging, 3-month follow-up; End of study at 1 year|Rate of Partial Hematoma Resolution, Rate of at least 50% or greater reduction in hematoma size from baseline on imaging, 3-month follow-up; End of study at 1 year|Change in Hematoma Size, Change in hematoma size measured in millimeters on imaging, Screening, 2 weeks, 3 months, 6 months, to end of study at 1 year|Rate of Clinical Symptoms, Change in occurrence of patient-reported symptoms, Screening, 2 weeks, 3 months, 6 months, to end of study at 1 year|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, Screening, 2 weeks, 3 months, 6 months, to end of study at 1 year|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, Screening, 2 weeks, 3 months, 6 months, to end of study at 1 year|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, Screening, 2 weeks, 3 months, 6 months, to end of study at 1 year|Change in Clinical Neurological Symptom Scale Scores: HIT-6, Change in Headache Impact Test (HIT-6) scores, ranging from 36 to 78, where a higher score indicates a greater impact of headache on the daily life of the responder, Screening, 2 weeks, 3 months, 6 months, to end of study at 1 year|Change in Clinical Neurological Symptom Scale Scores: MIDAS, Change in Migraine Disability Assessment (MIDAS) scores, 0 to 270. Higher scores indicate greater disability caused by headaches, Screening, 2 weeks, 3 months, 6 months, to end of study at 1 year
Other Outcome Measures: Number of Participants with Anatomical Variants, Middle meningeal arteries with dangerous anastomoses observed on imaging, During the treatment procedure