NCT06510582 Chronic Subdural Hematoma Treatment With Intra-Arterial Bevacizumab Injection
| NCT ID | NCT06510582 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | The Cooper Health System |
| Condition | Chronic Subdural Hematoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2024-06-17 |
| Primary Completion | 2028-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 140 participants in total. It began in 2024-06-17 with a primary completion date of 2028-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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?
Eligibility 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.
Contact & Investigator
Jane Khalife, MD
PRINCIPAL INVESTIGATOR
The Cooper Health System
Frequently Asked Questions
Who can join the NCT06510582 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Subdural Hematoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06510582 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06510582 currently recruiting?
Yes, NCT06510582 is actively recruiting participants. Visit ClinicalTrials.gov or contact The Cooper Health System to inquire about joining.
Where is the NCT06510582 trial being conducted?
This trial is being conducted at Camden, United States.
Who is sponsoring the NCT06510582 clinical trial?
NCT06510582 is sponsored by The Cooper Health System. The principal investigator is Jane Khalife, MD at The Cooper Health System. The trial plans to enroll 140 participants.