Chronic Subdural Hematoma Treatment With Intra-Arterial Bevacizumab Injection (CHAI)

June 25, 2025 updated by: Jane Khalife, MD, The Cooper Health System

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

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?

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
140

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Recruiting
        • Cooper University Health Care
        • Principal Investigator:
          • Jane Khalife, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Phase 1 Unilateral cSDH/ 2mg/kg Arm
During phase 1, single 2mg/kg dose of bevacizumab to treat unilateral cSDH
Drug: Bevacizumab 2 mg/kg
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
Drug: Bevacizumab 4 mg/kg
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
Drug: Bevacizumab 2 mg/kg
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
Drug: Bevacizumab 4 mg/kg
Two 2mg/kg doses (cumulatively 4mg/kg) of bevacizumab to treat bilateral cSDH

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Up to 3 months after study treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
3 months after study treatment and 6 months after study treatment
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 months after study treatment and 6 months after study treatment
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
3 months after study treatment and 6 months after study treatment
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
3 months after study treatment and 6 months after study treatment
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
3 months after study treatment and 6 months after study treatment
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
3 months after study treatment and 6 months after study treatment
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
3 months after study treatment and 6 months after study treatment

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants with Anatomical Variants
Time Frame: During the treatment procedure
Middle meningeal arteries with dangerous anastomoses observed on imaging
During the treatment procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Cooper Health System

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Society of Vascular and Interventional Neurology

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Manisha Koneru, MD, The Cooper Health System
  • Principal Investigator: Jane Khalife, MD, The Cooper Health System
  • Study Chair: Ajith J Thomas, MD, The Cooper Health System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 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
  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 17, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 28, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 14, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 19, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 1, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 23-154

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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