Chronic Subdural Hematoma Treatment With Intra-Arterial Bevacizumab Injection

NCT06510582 | Recruiting Phase 1 FDA Drug

• 1 other identifier: 23-154
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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?

Conditions

Chronic Subdural Hematoma

Keywords

Chronic subdural hematoma; Chronic intracranial subdural hematoma; Vascular endothelial growth factor; Bevacizumab; Middle meningeal artery embolization

Outcome Measures

Primary Outcomes (1)

• 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

  Up to 3 months after study treatment

Secondary Outcomes (7)

• Rate of Hematoma Recurrence

  3 months after study treatment and 6 months after study treatment

• Rate of Complete Hematoma Resolution

  3 months after study treatment and 6 months after study treatment

• Rate of Partial Hematoma Resolution

  3 months after study treatment and 6 months after study treatment

• Change in Hematoma Size

  3 months after study treatment and 6 months after study treatment

• Change in Clinical Neurological Symptom Scale Scores: NIHSS

  3 months after study treatment and 6 months after study treatment

Other Outcomes (1)

• Number of Participants with Anatomical Variants

  During the treatment procedure

Study Arms (4)

Phase 1 Unilateral cSDH/ 2mg/kg Arm

EXPERIMENTAL

During phase 1, single 2mg/kg dose of bevacizumab to treat unilateral cSDH

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

Drug: Bevacizumab 4 mg/kg

Phase 2 Unilateral cSDH/ 2mg/kg Arm

EXPERIMENTAL

During phase 2, single 2mg/kg dose of bevacizumab to treat unilateral cSDH

Drug: Bevacizumab 2 mg/kg

Phase 2 Bilateral cSDH/ 4mg/kg Arm

EXPERIMENTAL

During phase 2, two 2mg/kg doses (cumulatively 4mg/kg) of bevacizumab to treat bilateral cSDH

Drug: Bevacizumab 4 mg/kg

Interventions

Bevacizumab 2 mg/kg DRUG

Single 2mg/kg dose of bevacizumab to treat unilateral cSDH

Phase 1 Unilateral cSDH/ 2mg/kg Arm; Phase 2 Unilateral cSDH/ 2mg/kg Arm

Bevacizumab 4 mg/kg DRUG

Two 2mg/kg doses (cumulatively 4mg/kg) of bevacizumab to treat bilateral cSDH

Phase 1 Bilateral cSDH/ 4mg/kg Arm; Phase 2 Bilateral cSDH/ 4mg/kg Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Cooper Health System: lead
• Society of Vascular and Interventional Neurology: collaborator

Study Sites (1)

Cooper University Health Care

Camden, New Jersey, 08103, United States

RECRUITING

Related Publications (2)

• 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

  BACKGROUND

• 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

  BACKGROUND

MeSH Terms

Conditions

Hematoma, Subdural, Chronic

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Hematoma, Subdural; Intracranial Hemorrhage, Traumatic; Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Vascular Diseases; Cardiovascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematoma; Hemorrhage; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Jane Khalife, MD

  The Cooper Health System

  PRINCIPAL INVESTIGATOR

• Ajith J Thomas, MD

  The Cooper Health System

  STUDY CHAIR

• Manisha Koneru, MD

  The Cooper Health System

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Neurology

Study Record Dates

• First Submitted: June 28, 2024
• First Posted: July 19, 2024
• Study Start: June 17, 2024
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: July 1, 2025

Record last verified: 2025-06

Locations

US (1)