Recruiting
Phase 1
Phase 2

Bevacizumab

Sponsor:

The Cooper Health System

Code:

NCT06510582

Conditions

Chronic Subdural Hematoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Bevacizumab 2 mg/kg

Bevacizumab 4 mg/kg

Study Details

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 ID

NCT06510582

Start date

Jun 17, 2024

Status verified date

Jun, 2025

Completion date

Jun, 2028

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

140 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Phase 1 Unilateral cSDH/ 2mg/kg Arm

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

experimental: Phase 1 Bilateral cSDH/ 4mg/kg Arm

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

experimental: Phase 2 Unilateral cSDH/ 2mg/kg Arm

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

experimental: Phase 2 Bilateral cSDH/ 4mg/kg Arm

During phase 2, 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

Bevacizumab 4 mg/kg

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

Primary outcome measure

  • Number of Participants with Serious Adverse Events [ Time Frame: Up to 3 months after study treatment ]

Central Contacts and Locations

Locations

Cooper University Health Care

Recruiting

Camden, New Jersey, United States, 08103

Contacts

Cooper Neurological Institute

855-306-3876cniresearch@cooperhealth.edu

Principal Investigator:

Jane Khalife, MD

More Information

Sponsor

The Cooper Health System

Last update posted

Jul 1, 2025

Last verified

Jun, 2025

Keywords

  • Chronic subdural hematoma
  • Chronic intracranial subdural hematoma
  • Vascular endothelial growth factor
  • Bevacizumab
  • Middle meningeal artery embolization

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Cooper Health System on 2025-07-01.