Intraarterial Bevacizumab Administration Through the Middle Meningeal Artery for Chronic Subdural Hematoma.
Jane Khalife, Daniel A Tonetti, Hamza Shaikh...
https://pubmed.ncbi.nlm.nih.gov/41583665Actively Recruiting
Phase 1
Phase 2
Age: 18Years +
All Genders
ID06510582
Chronic Subdural Hematoma Treatment With Avastin4 (Bevacizumab) Intra-Arterial Injection: A Non-Randomized, Open-Label Phase 1/2 Clinical Trial
Led by The Cooper Health System · Updated on 2025-07-01
140
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
T
The Cooper Health System
Lead Sponsor
S
Society of Vascular and Interventional Neurology
Collaborating Sponsor
AI-Summary
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 1/2 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 mg/kg dose of bevacizumab, while those with bilateral cSDH receive two 2 mg/kg doses for a total of 4 mg/kg. 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.
CONDITIONS
Brief Title
Chronic Subdural Hematoma Treatment With Intra-Arterial Bevacizumab Injection
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adult patients aged 18 years or older
- Radiographic evidence of chronic subdural hematoma including persistence of subdural blood more than 10 days after injury
- Presence of mixed density blood on imaging
- Presence of subdural membranes
- Ability to provide informed consent and HIPAA authorization
You will not qualify if you...
- Pregnant or breastfeeding individuals, or those unwilling to use contraception during the study
- Patients with other intracranial pathology besides subdural hematoma
- Known hypersensitivity to bevacizumab
- Radiographic evidence of mass effect
- Focal neurological deficits caused by subdural hematoma
- Recent craniotomy or burr hole surgery within two weeks before hematoma onset
- Chronic subdural hematoma caused by factors other than trauma, such as vascular abnormalities or tumors
- Need for emergency surgical evacuation
- Non-convexity chronic subdural hematoma not supplied by the middle meningeal artery
- Coagulation abnormalities including low platelet count or abnormal INR despite correction
- Contraindications to angiography or contrast allergy without premedication
- Active systemic infection or sepsis
- Contraindications to anesthetic agents used for conscious sedation
- Life expectancy less than six months due to terminal conditions
- Premorbid modified Rankin score of 5 or greater
- Concurrent participation in another experimental therapy research protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Single dose or two doses given during the treatment phase
Participants receive either a single dose or two doses of bevacizumab to treat chronic subdural hematoma.
1 to 2 visits depending on dosing schedule
Follow-up
Duration - Up to 6 months after study treatment
Participants are monitored for safety and hematoma resolution up to 6 months after treatment.
Several visits over 6 months for assessments
Trial Site Locations
Total: 1 location
1
Cooper University Health Care
Camden, New Jersey, United States, 08103
Actively Recruiting
Loading map...
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
Intra-arterial Selective Bevacizumab Administration in the Middle Meningeal Artery for Chronic Subdural Hematoma: An Early Experience in 12 Hemispheres.
Jane Khalife, Manisha Koneru, Daniel A Tonetti...
https://pubmed.ncbi.nlm.nih.gov/41586284