Cooper University Health Care
Camden, New Jersey, 08103, United States
Location status: Recruiting
Location contact
Cooper Neurological Institute
CONTACT
Jane Khalife, MD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06510582
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?
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 1 / Phase 2
Camden, New Jersey, 08103, United States
Location status: Recruiting
Cooper Neurological Institute
CONTACT
Jane Khalife, MD
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Single 2mg/kg dose of bevacizumab to treat unilateral cSDH
Two 2mg/kg doses (cumulatively 4mg/kg) of bevacizumab to treat bilateral cSDH
Time frame: 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
Time frame: 3 months after study treatment and 6 months after study treatment
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 compared to baseline on imaging
Time frame: 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
Time frame: 3 months after study treatment and 6 months after study treatment
Change in hematoma size measured in millimeters on imaging
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: During the treatment procedure
Middle meningeal arteries with dangerous anastomoses observed on imaging
The Cooper Health System
Other
Chronic Subdural Hematoma Treatment With Avastin® (Bevacizumab) Intra-Arterial Injection: A Non-Randomized, Open-Label Phase 1/2 Clinical Trial
Acronym: CHAI
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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