Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06510582

Chronic Subdural Hematoma Treatment With Intra-Arterial Bevacizumab Injection

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?

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Cooper University Health Care

Camden, New Jersey, 08103, United States

Location status: Recruiting

Location contact

Cooper Neurological Institute

CONTACT

[email protected]

855-306-3876

Jane Khalife, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients (≥18 years)
  • Radiographic evidence of chronic subdural hematoma, including
  • Persistence of subdural blood more than 10 days after index traumatic injury or event
  • Presence of mixed density blood
  • 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.

Treatment and study plan

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

Primary outcomes

  1. Number of Participants with Serious Adverse Events

    Time frame: Up to 3 months after study treatment

    Reported serious adverse events classified using MedDRA and CTCAE, in addition to treatment-related events and all other adverse events

Secondary outcomes

  1. Rate of Hematoma Recurrence

    Time frame: 3 months after study treatment and 6 months after study treatment

    Rate of hematoma recurrence or progression requiring intervention and/or readmission

  2. Rate of Complete Hematoma Resolution

    Time frame: 3 months after study treatment and 6 months after study treatment

    Rate of complete hematoma resolution compared to baseline on imaging

  3. Rate of Partial Hematoma Resolution

    Time frame: 3 months after study treatment and 6 months after study treatment

    Rate of at least 50% or greater reduction in hematoma size from baseline on imaging

  4. Change in Hematoma Size

    Time frame: 3 months after study treatment and 6 months after study treatment

    Change in hematoma size measured in millimeters on imaging

  5. Change in Clinical Neurological Symptom Scale Scores: NIHSS

    Time frame: 3 months after study treatment and 6 months after study treatment

    Change in National Institutes of Health Stroke Scale (NIHSS) scores, scores range from 0 to 42, with higher scores indicating more severe neurological deficit

  6. Change in Clinical Neurological Symptom Scale Scores: GCS

    Time frame: 3 months after study treatment and 6 months after study treatment

    Change in Glasgow Coma Scale (GCS) scores, ranging from 3 to 15 with lower score indicating more impaired consciousness

  7. Change in Clinical Neurological Symptom Scale Scores: mRS

    Time frame: 3 months after study treatment and 6 months after study treatment

    Change in modified Rankin Scale (mRS) scores, ranges from 0-6 with higher score indicating worse functional outcome

Other outcomes

  1. Number of Participants with Anatomical Variants

    Time frame: During the treatment procedure

    Middle meningeal arteries with dangerous anastomoses observed on imaging

Sponsors and collaborators

Lead sponsor

The Cooper Health System

Other

Collaborators

  • Society of Vascular and Interventional Neurology

Registry information

Official study title

Chronic Subdural Hematoma Treatment With Avastin® (Bevacizumab) Intra-Arterial Injection: A Non-Randomized, Open-Label Phase 1/2 Clinical Trial

Acronym: CHAI

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Jul 19, 2024
Registry last updated
Jul 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.