Chronic Subdural Hematoma Treatment With Intra-Arterial Bevacizumab Injection

NCT ID: NCT06510582

Last Updated: 2025-07-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-17
• Study Completion Date: 2028-06-30

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?

Conditions

Chronic Subdural Hematoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Phase 1 Unilateral cSDH/ 2mg/kg Arm

During phase 1, single 2mg/kg dose of bevacizumab to treat unilateral cSDH

Group Type: EXPERIMENTAL

Bevacizumab 2 mg/kg

Intervention Type: DRUG

Single 2mg/kg dose of bevacizumab to treat unilateral cSDH

Phase 1 Bilateral cSDH/ 4mg/kg Arm

During phase 1, two 2mg/kg doses (cumulatively 4mg/kg) of bevacizumab to treat bilateral cSDH

Group Type: EXPERIMENTAL

Bevacizumab 4 mg/kg

Intervention Type: DRUG

Two 2mg/kg doses (cumulatively 4mg/kg) of bevacizumab to treat bilateral cSDH

Phase 2 Unilateral cSDH/ 2mg/kg Arm

During phase 2, single 2mg/kg dose of bevacizumab to treat unilateral cSDH

Group Type: EXPERIMENTAL

Bevacizumab 2 mg/kg

Intervention Type: DRUG

Single 2mg/kg dose of bevacizumab to treat unilateral cSDH

Phase 2 Bilateral cSDH/ 4mg/kg Arm

During phase 2, two 2mg/kg doses (cumulatively 4mg/kg) of bevacizumab to treat bilateral cSDH

Group Type: EXPERIMENTAL

Bevacizumab 4 mg/kg

Intervention Type: DRUG

Two 2mg/kg doses (cumulatively 4mg/kg) of bevacizumab to treat bilateral cSDH

Interventions

Bevacizumab 2 mg/kg

Single 2mg/kg dose of bevacizumab to treat unilateral cSDH

Intervention Type: DRUG

Bevacizumab 4 mg/kg

Two 2mg/kg doses (cumulatively 4mg/kg) of bevacizumab to treat bilateral cSDH

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Society of Vascular and Interventional Neurology

UNKNOWN

Sponsor Role: collaborator

The Cooper Health System

OTHER

Sponsor Role: lead

Responsible Party

Jane Khalife, MD

Assistant Professor of Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jane Khalife, MD

Role: PRINCIPAL_INVESTIGATOR

The Cooper Health System

Ajith J Thomas, MD

Role: STUDY_CHAIR

The Cooper Health System

Manisha Koneru, MD

Role: STUDY_CHAIR

The Cooper Health System

Locations

Cooper University Health Care

Camden, New Jersey, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Cooper Neurological Institute

Role: primary

cniresearch@cooperhealth.edu

855-306-3876

References

Khalife J, Tonetti DA, Shaikh H, Jovin T, Patel P, Thomas A. Intraarterial bevacizumab administration through the middle meningeal artery for chronic subdural hematoma. Stroke: Vascular and Interventional Neurology. 2023 Jul;3(4). doi:10.1161/svin.122.000722

Reference Type: BACKGROUND

Khalife J, Koneru M, Tonetti DA, Shaikh HA, Jovin TG, Patel PD, et al. Intra-arterial selective bevacizumab administration in the middle meningeal artery for chronic subdural hematoma: An early experience in 12 Hemispheres. Stroke: Vascular and Interventional Neurology. 2024 Sept;4(5). doi:10.1161/svin.124.001409

Reference Type: BACKGROUND

Other Identifiers

23-154

Identifier Type: -

Identifier Source: org_study_id