Clinical trial NCT06510582: Chronic Subdural Hematoma Treatment With Intra-Arterial Bevacizumab Injection
Official title: Chronic Subdural Hematoma Treatment With Avastin® (Bevacizumab) Intra-Arterial Injection: A Non-Randomized, Open-Label Phase 1/2 Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Chronic Subdural Hematoma
Keywords: Chronic subdural hematoma
Chronic intracranial subdural hematoma
Vascular endothelial growth factor
Bevacizumab
Middle meningeal artery embolization
Lead sponsor: The Cooper Health System
Sponsor class: OTHER
First posted: 2024-07-19
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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?


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants with Serious Adverse Events
timeFrame: Screening to end of study follow-up at 1 year
Secondary outcomes:
measure: Rate of Hematoma Recurrence
timeFrame: 3-month follow-up; End of study at 1 year
measure: Rate of Complete Hematoma Resolution
timeFrame: 3-month follow-up; End of study at 1 year
measure: Rate of Partial Hematoma Resolution
timeFrame: 3-month follow-up; End of study at 1 year
measure: Change in Hematoma Size
timeFrame: Screening, 2 weeks, 3 months, 6 months, to end of study at 1 year
measure: Rate of Clinical Symptoms
timeFrame: Screening, 2 weeks, 3 months, 6 months, to end of study at 1 year
measure: Change in Clinical Neurological Symptom Scale Scores: NIHSS
timeFrame: Screening, 2 weeks, 3 months, 6 months, to end of study at 1 year
measure: Change in Clinical Neurological Symptom Scale Scores: mRS
timeFrame: Screening, 2 weeks, 3 months, 6 months, to end of study at 1 year
measure: Change in Clinical Neurological Symptom Scale Scores: GCS
timeFrame: Screening, 2 weeks, 3 months, 6 months, to end of study at 1 year
measure: Change in Clinical Neurological Symptom Scale Scores: HIT-6
timeFrame: Screening, 2 weeks, 3 months, 6 months, to end of study at 1 year
measure: Change in Clinical Neurological Symptom Scale Scores: MIDAS
timeFrame: Screening, 2 weeks, 3 months, 6 months, to end of study at 1 year
Other outcomes:
measure: Number of Participants with Anatomical Variants
timeFrame: During the treatment procedure
Locations:
city: Camden
country: United States
facility: Cooper University Health Care
state: New Jersey
Study officials:
affiliation: Cooper Neurological Institute
name: Jane Khalife, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cooper Neurological Institute
name: Ajith Thomas, MD
role: STUDY_DIRECTOR
References: