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Recruiting NCT06510582

Chronic Subdural Hematoma Treatment With Intra-Arterial Bevacizumab Injection

Phase I / Phase II Interventional Chronic Subdural Hematoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Bevacizumab 2 mg/kg, Bevacizumab 4 mg/kg.
Who it may be relevant to
Registry conditions: Chronic Subdural Hematoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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?

Interventions

  • Drug Bevacizumab 2 mg/kg
    Single 2mg/kg dose of bevacizumab to treat unilateral cSDH
  • Drug Bevacizumab 4 mg/kg
    Two 2mg/kg doses (cumulatively 4mg/kg) of bevacizumab to treat bilateral cSDH

Primary outcome measures

  • Number of Participants with Serious Adverse Events [Time frame: Up to 3 months after study treatment]
Secondary outcome measures (7)
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Cooper University Health Care — Camden

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 Vasc Interv Neurol. 2023 Feb 25;3(4):e000722. doi: 10.1161/SVIN.122.000722. eCollection 2023 Jul. PMID 41583665
  • Khalife 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. PMID 41586284

Identifiers

NCT: NCT06510582 · 23-154

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗