Chronic Subdural Hematoma Treatment With Intra-Arterial Bevacizumab Injection

Launched by THE COOPER HEALTH SYSTEM · Jul 14, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new way to treat chronic subdural hematomas (cSDH), which are collections of blood that can form between the brain and its outer covering after an injury. The researchers want to find out if injecting a medication called bevacizumab directly into the blood vessels supplying the area is safe and effective for patients. The trial is currently looking for adult participants aged 18 and older who have evidence of a chronic subdural hematoma that has not improved for at least 10 days after the initial injury.

To participate, patients must not have certain conditions, such as active infections or serious other brain issues, and they should be able to give informed consent. If enrolled, participants can expect to receive this injection and will be closely monitored for safety and effectiveness. This study may provide new insights into treating chronic subdural hematomas, potentially helping many patients in the future.

Gender

ALL

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.