Chronic Subdural Hematoma Treatment With Intra-Arterial Bevacizumab Injection

Part of paid clinical trials in Camden, New Jersey.

Sponsor
The Cooper Health System
Study ID
NCT06510582
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Chronic Subdural Hematoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab 2 mg/kg — DRUG
    Single 2mg/kg dose of bevacizumab to treat unilateral cSDH
  • Bevacizumab 4 mg/kg — DRUG
    Two 2mg/kg doses (cumulatively 4mg/kg) of bevacizumab to treat bilateral cSDH

Study Details

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?

Key Dates

Start date
Jun 17, 2024
Status verified
Jun 2025
Primary completion
Jun 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
140 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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

Primary Outcome Measure

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

Locations (1)

FacilityCityStateZIPSite coordinators
Cooper University Health CareCamdenNew Jersey08103
Cooper Neurological Institute
[email protected]
855-306-3876
Jane Khalife, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Camden, NJ

By research site
Cooper University Health Care· Camden, NJ

Related Studies