Chronic Subdural Hematoma Treatment With Intra-Arterial Bevacizumab Injection

Last updated: July 18, 2024
Sponsor: The Cooper Health System
Overall Status: Active - Recruiting

Phase

1/2

Condition

N/A

Treatment

Bevacizumab 4 mg/kg

Bevacizumab 2 mg/kg

Clinical Study ID

NCT06510582
23-154
  • Ages > 18
  • All Genders

Study 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?

Eligibility Criteria

Inclusion

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 orevent

  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

Exclusion Criteria:

  • Pregnant, breastfeeding, or unwilling to practice contraception during participationin 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 twoweeks prior to onset of subdural hematoma.

  • Secondary causes apart from trauma for the chronic subdural hematoma, such asunderlying vascular abnormality or tumor.

  • Emergent surgical evacuation is required for the patient.

  • Non-convexity chronic subdural hematoma, as the middle meningeal artery will notsupply this area.

  • Coagulation abnormalities, including platelet count <100,000 and/or internationalnormalized ratio of <1.5 despite attempts for correction.

  • Patients with known contraindications for angiography. Patients with contrastallergy 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/monitoredanesthesia care (MAC).

  • Patient has life expectancy of less than six months due to comorbid terminalconditions.

  • Patient has a premorbid modified Rankin score (mRS) of 5 or greater.

  • Concurrent participation in another research protocol for investigation of anexperimental therapy.

Study Design

Total Participants: 140
Treatment Group(s): 2
Primary Treatment: Bevacizumab 4 mg/kg
Phase: 1/2
Study Start date:
June 17, 2024
Estimated Completion Date:
June 17, 2028

Connect with a study center

  • Cooper University Health Care

    Camden, New Jersey 08103
    United States

    Active - Recruiting

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