Treatment of chronic subdural hematoma using bevacizumab injection
Chronic Subdural Hematoma Treatment With Avastin® (Bevacizumab) Intra-Arterial Injection: A Non-Randomized, Open-Label Phase 1/2 Clinical Trial
This study is testing if injecting a medication called bevacizumab into the arteries can help adults with chronic subdural hematomas feel better and clear up the blood buildup.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Cooper Health System Academic / other |
| Drugs / interventions | bevacizumab |
| Locations | 1 site (Camden, New Jersey) |
| Trial ID | NCT06510582 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety and effectiveness of infusing bevacizumab into the middle meningeal arteries for treating chronic subdural hematomas (cSDH). It involves administering two different doses of bevacizumab to adult patients with radiographic evidence of cSDH. The study will assess whether this approach can improve patient outcomes and reduce the persistence of subdural blood. Participants will be monitored for any adverse effects and the overall efficacy of the treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with radiographic evidence of chronic subdural hematoma persisting for more than 10 days after an injury.
Not a fit: Patients with other intracranial pathologies, recent surgeries, or known hypersensitivity to bevacizumab may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new, less invasive option for managing chronic subdural hematomas.
How similar studies have performed: While the use of bevacizumab in this context is novel, similar approaches in treating other conditions have shown promise.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients (≥18 years) * Radiographic evidence of chronic subdural hematoma, including 1. Persistence of subdural blood more than 10 days after index traumatic injury or event 2. Presence of mixed density blood 3. 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 this trial is running
Camden, New Jersey
- Cooper University Health Care — Camden, New Jersey, United States (Recruiting)
Study contacts
- Principal investigator: Jane Khalife, MD — The Cooper Health System
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.