Chronic Subdural HematomaPhase 1CHAINCT06510582
Chronic Subdural Hematoma Treatment With Intra-Arterial Bevacizumab Injection
A Phase 1 study testing Bevacizumab 2 mg/kg and Bevacizumab 4 mg/kg in people with Chronic Subdural Hematoma, run by Cooper Norcross Health at 1 site in United States.
Trial 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? Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Subdural Hematoma
- What is being tested?
- Bevacizumab 2 mg/kg and Bevacizumab 4 mg/kg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jun 2024to 28 Sep 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cooper University Health Care
Camden, New Jersey, 08103
About this study
Official title: 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?
Read the detailed description
This protocol was originally proposed as a phase I/II trial. Phase 1 was completed; planned phase 2 was discontinued prior to initiation.
- Conditions
- Chronic Subdural Hematoma
- Being tested
- Bevacizumab 2 mg/kg, Bevacizumab 4 mg/kg
- Keywords
- Chronic subdural hematoma, Chronic intracranial subdural hematoma, Vascular endothelial growth factor, Bevacizumab, Middle meningeal artery embolization
- Medical subject headings
- Hematoma, Subdural, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bevacizumab 2 mg/kgDrug
Single 2mg/kg dose of bevacizumab to treat unilateral cSDH
Bevacizumab 4 mg/kgDrug
Two 2mg/kg doses (cumulatively 4mg/kg) of bevacizumab to treat bilateral cSDH
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 Unilateral cSDH/ 2mg/kg Arm | Experimental | During phase 1, single 2mg/kg dose of bevacizumab to treat unilateral cSDH Receives: Drug: Bevacizumab 2 mg/kg |
| Phase 1 Bilateral cSDH/ 4mg/kg Arm | Experimental | During phase 1, two 2mg/kg doses (cumulatively 4mg/kg) of bevacizumab to treat bilateral cSDH Receives: Drug: Bevacizumab 4 mg/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Serious Adverse Events
Reported serious adverse events classified using MedDRA and CTCAE, in addition to treatment-related events and all other adverse events
Measured: Up to 3 months after study treatment
Secondary outcomes (7)
Rate of Hematoma Recurrence
Rate of hematoma recurrence or progression requiring intervention and/or readmission
Measured: 3 months after study treatment and 6 months after study treatment
Rate of Complete Hematoma Resolution
Rate of complete hematoma resolution compared to baseline on imaging
Measured: 3 months after study treatment and 6 months after study treatment
Rate of Partial Hematoma Resolution
Rate of at least 50% or greater reduction in hematoma size from baseline on imaging
Measured: 3 months after study treatment and 6 months after study treatment
Change in Hematoma Size
Change in hematoma size measured in millimeters on imaging
Measured: 3 months after study treatment and 6 months after study treatment
Change in Clinical Neurological Symptom Scale Scores: NIHSS
Change in National Institutes of Health Stroke Scale (NIHSS) scores, scores range from 0 to 42, with higher scores indicating more severe neurological deficit
Measured: 3 months after study treatment and 6 months after study treatment
Change in Clinical Neurological Symptom Scale Scores: GCS
Change in Glasgow Coma Scale (GCS) scores, ranging from 3 to 15 with lower score indicating more impaired consciousness
Measured: 3 months after study treatment and 6 months after study treatment
Change in Clinical Neurological Symptom Scale Scores: mRS
Change in modified Rankin Scale (mRS) scores, ranges from 0-6 with higher score indicating worse functional outcome
Measured: 3 months after study treatment and 6 months after study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start17 Jun 2024
- Primary completion27 Jul 2026
- Study completion28 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Subdural HematomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cooper Norcross Health
- Sponsor type
- University, hospital or other
- Collaborators
- Society of Vascular and Interventional Neurology
- Responsible party
- Principal investigator, Jane Khalife, MD, Cooper Norcross Health
- Investigators
- Jane Khalife, MD, Principal investigator, Cooper Norcross HealthAjith J Thomas, MD, Study chair, Cooper Norcross HealthManisha Koneru, MD, Study chair, Cooper Norcross Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06510582
- Sponsor's protocol ID
- 23-154
- Acronym
- CHAI
- Status last verified
- Sep 2026
- First submitted
- 28 Jun 2024
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Khalife J, Koneru M, Thomas AJ. Inflammation as a Key Driver for Chronic Subdural Hematomas. Stroke. 2026 Jul;57(7):1908-1919. doi: 10.1161/STROKEAHA.126.055340. Epub 2026 May 27.
PubMed 42200273Khalife J, Koneru M, Tonetti DA, Shaikh HA, Jovin TG, Patel PD, Thomas AJ. Intra-arterial Selective Bevacizumab Administration in the Middle Meningeal Artery for Chronic Subdural Hematoma: An Early Experience in 12 Hemispheres. Stroke Vasc Interv Neurol. 2024 Jul 22;4(5):e001409. doi: 10.1161/SVIN.124.001409. eCollection 2024 Sep.
PubMed 41586284Khalife J, Tonetti DA, Shaikh H, Jovin T, Patel P, Thomas A. Intraarterial Bevacizumab Administration Through the Middle Meningeal Artery for Chronic Subdural Hematoma. Stroke Vasc Interv Neurol. 2023 Feb 25;3(4):e000722. doi: 10.1161/SVIN.122.000722. eCollection 2023 Jul.
PubMed 41583665
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Subdural Hematoma Treatment With Avastin® (Bevacizumab) Intra-Arterial Injection: A Non-Randomized, Open-Label Phase 1/2 Clinical Trial
- ClinicalTrials.gov ID
- NCT06510582
- Acronym / sponsor ID
- CHAI / 23-154
- Conditions
- Chronic Subdural Hematoma
- Keywords
- Chronic subdural hematoma, Chronic intracranial subdural hematoma, Vascular endothelial growth factor, Bevacizumab, Middle meningeal artery embolization
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Cooper Norcross HealthUniversity, hospital or other
- Collaborators
- Society of Vascular and Interventional Neurology
- Study start
- 17 Jun 2024 (actual)
- Primary completion
- 27 Jul 2026 (actual)
- Study completion
- 28 Sep 2026 (actual)
- First posted
- 19 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Detailed description
This protocol was originally proposed as a phase I/II trial. Phase 1 was completed; planned phase 2 was discontinued prior to initiation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase 1 Unilateral cSDH/ 2mg/kg Arm | Experimental | Drug: Bevacizumab 2 mg/kgDuring phase 1, single 2mg/kg dose of bevacizumab to treat unilateral cSDH |
| Phase 1 Bilateral cSDH/ 4mg/kg Arm | Experimental | Drug: Bevacizumab 4 mg/kgDuring phase 1, two 2mg/kg doses (cumulatively 4mg/kg) of bevacizumab to treat bilateral cSDH |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult patients (≥18 years)
- Radiographic evidence of chronic subdural hematoma, including
- Can obtain informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bevacizumab 2 mg/kgSingle 2mg/kg dose of bevacizumab to treat unilateral cSDH | Drug | Phase 1 Unilateral cSDH/ 2mg/kg Arm |
| Bevacizumab 4 mg/kgTwo 2mg/kg doses (cumulatively 4mg/kg) of bevacizumab to treat bilateral cSDH | Drug | Phase 1 Bilateral cSDH/ 4mg/kg Arm |
Primary outcome
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
7 secondary outcomes
Rate of Hematoma Recurrence
Time frame: 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 Partial Hematoma Resolution
Time frame: 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 Clinical Neurological Symptom Scale Scores: NIHSS
Time frame: 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 Clinical Neurological Symptom Scale Scores: mRS
Time frame: 3 months after study treatment and 6 months after study treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Background: PubMed 42200273Khalife J, Koneru M, Thomas AJ. Inflammation as a Key Driver for Chronic Subdural Hematomas. Stroke. 2026 Jul;57(7):1908-1919. doi: 10.1161/STROKEAHA.126.055340. Epub 2026 May 27.
- Background: PubMed 41586284Khalife J, Koneru M, Tonetti DA, Shaikh HA, Jovin TG, Patel PD, Thomas AJ. Intra-arterial Selective Bevacizumab Administration in the Middle Meningeal Artery for Chronic Subdural Hematoma: An Early Experience in 12 Hemispheres. Stroke Vasc Interv Neurol. 2024 Jul 22;4(5):e001409. doi: 10.1161/SVIN.124.001409. eCollection 2024 Sep.
- Background: PubMed 41583665Khalife J, Tonetti DA, Shaikh H, Jovin T, Patel P, Thomas A. Intraarterial Bevacizumab Administration Through the Middle Meningeal Artery for Chronic Subdural Hematoma. Stroke Vasc Interv Neurol. 2023 Feb 25;3(4):e000722. doi: 10.1161/SVIN.122.000722. eCollection 2023 Jul.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jane Khalife, MD principal investigator
Cooper Norcross Health
Ajith J Thomas, MD study chair
Cooper Norcross Health
Manisha Koneru, MD study chair
Cooper Norcross Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Bevacizumab 2 mg/kg and Bevacizumab 4 mg/kg in people with Chronic Subdural Hematoma, run by Cooper Norcross Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Serious Adverse Events (time frame: Up to 3 months after study treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06510582, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.