NCT06510582 · The Cooper Health System
Chronic Subdural Hematoma Treatment With Intra-Arterial Bevacizumab Injection
(CHAI)
What this study is about
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).
View original scientific description
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).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
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., intracranial malignancy).
- Patients with known hypersensitivity to bevacizumab.
- Patients with radiographic evidence of mass effect.
- Patients have focal neurological deficits attributed to subdural hematoma.
- Patient had craniotomy or burr hole operative procedures performed in preceding two weeks prior to onset of subdural hematoma.
- Secondary causes apart from trauma for the chronic subdural hematoma, such as underlying vascular abnormality or tumor.
- Emergent surgical evacuation is required for the patient.
- Non-convexity chronic subdural hematoma, as the middle meningeal artery will not supply this area.
- Coagulation abnormalities, including platelet count \<100,000 and/or international normalized ratio of \<1.5 despite attempts for correction.
- Patients with known contraindications for angiography. Patients with contrast allergy will be premedicated with diphenhydramine and steroids.
- Patient has known active systemic infection or sepsis.
- Patient has contradiction to anesthetic agents used for conscious sedation/monitored anesthesia care (MAC).
- Patient has life expectancy of less than six months due to comorbid terminal conditions.
- Patient has a premorbid modified Rankin score (mRS) of 5 or greater.
- Concurrent participation in another research protocol for investigation of an experimental therapy.
Where
- Camden, New Jersey
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 1, 2025 · Source of record for eligibility and locations