Phase 12 Study of Bevacizumab Infusion into Middle Meningeal Arteries to Treat Chronic Subdural Hematoma

What this Trial Is About

Researchers are studying the use of bevacizumab infusion into the middle meningeal arteries to treat chronic subdural hematomas cSDH. The trial aims to answer whether this treatment is safe and effective for patients with this condition. The study is a non-randomized, open-label phase 12 clinical trial led by The Cooper Health System. The study includes different treatment groups based on the phase and whether the cSDH is unilateral or bilateral. In phase 1 and phase 2, patients with unilateral cSDH receive a single 2 mgkg dose of bevacizumab, while those with bilateral cSDH receive two 2 mgkg doses for a total of 4 mgkg. The drug is delivered via intra-arterial injection into the middle meningeal arteries. Participants will be monitored for serious adverse events up to three months after treatment. Researchers will assess hematoma recurrence, complete and partial resolution rates, changes in hematoma size, and neurological function using NIHSS, GCS, and mRS scores at three and six months after treatment. The study will continue until June 2028, with ongoing safety and effectiveness evaluations throughout the follow-up periods.

Chronic Subdural Hematoma Treatment With Intra-Arterial Bevacizumab Injection