Chronic Subdural Hematoma Treatment With Intra-Arterial Bevacizumab Injection
- Conditions
- Chronic Subdural Hematoma
- Interventions
- Registration Number
- NCT06510582
- Lead Sponsor
- The Cooper Health System
- 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?
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 140
-
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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Phase 1 Bilateral cSDH/ 4mg/kg Arm Bevacizumab 4 mg/kg During phase 1, two 2mg/kg doses (cumulatively 4mg/kg) of bevacizumab to treat bilateral cSDH Phase 2 Unilateral cSDH/ 2mg/kg Arm Bevacizumab 2 mg/kg During phase 2, single 2mg/kg dose of bevacizumab to treat unilateral cSDH Phase 1 Unilateral cSDH/ 2mg/kg Arm Bevacizumab 2 mg/kg During phase 1, single 2mg/kg dose of bevacizumab to treat unilateral cSDH Phase 2 Bilateral cSDH/ 4mg/kg Arm Bevacizumab 4 mg/kg During phase 2, two 2mg/kg doses (cumulatively 4mg/kg) of bevacizumab to treat bilateral cSDH
- Primary Outcome Measures
Name Time Method Number of Participants with Serious Adverse Events Screening to end of study follow-up at 1 year Reported serious adverse events classified using MedDRA and CTCAE, in addition to treatment-related events and all other adverse events
- Secondary Outcome Measures
Name Time Method Rate of Clinical Symptoms Screening, 2 weeks, 3 months, 6 months, to end of study at 1 year Change in occurrence of patient-reported symptoms
Change in Hematoma Size Screening, 2 weeks, 3 months, 6 months, to end of study at 1 year Change in hematoma size measured in millimeters on imaging
Change in Clinical Neurological Symptom Scale Scores: NIHSS Screening, 2 weeks, 3 months, 6 months, to end of study at 1 year Change in National Institutes of Health Stroke Scale (NIHSS) scores, scores range from 0 to 42, with higher scores indicating more severe neurological deficit
Change in Clinical Neurological Symptom Scale Scores: MIDAS Screening, 2 weeks, 3 months, 6 months, to end of study at 1 year Change in Migraine Disability Assessment (MIDAS) scores, 0 to 270. Higher scores indicate greater disability caused by headaches
Rate of Partial Hematoma Resolution 3-month follow-up; End of study at 1 year Rate of at least 50% or greater reduction in hematoma size from baseline on imaging
Rate of Hematoma Recurrence 3-month follow-up; End of study at 1 year Rate of hematoma recurrence or progression requiring intervention and/or readmission
Rate of Complete Hematoma Resolution 3-month follow-up; End of study at 1 year Rate of complete hematoma resolution compared to baseline on imaging
Change in Clinical Neurological Symptom Scale Scores: mRS Screening, 2 weeks, 3 months, 6 months, to end of study at 1 year Change in modified Rankin Scale (mRS) scores, ranges from 0-6 with higher score indicating worse functional outcome
Change in Clinical Neurological Symptom Scale Scores: GCS Screening, 2 weeks, 3 months, 6 months, to end of study at 1 year Change in Glasgow Coma Scale (GCS) scores, ranging from 3 to 15 with lower score indicating more impaired consciousness
Change in Clinical Neurological Symptom Scale Scores: HIT-6 Screening, 2 weeks, 3 months, 6 months, to end of study at 1 year Change in Headache Impact Test (HIT-6) scores, ranging from 36 to 78, where a higher score indicates a greater impact of headache on the daily life of the responder
Trial Locations
- Locations (1)
Cooper University Health Care
🇺🇸Camden, New Jersey, United States