RECRUITING

Chronic Subdural Hematoma Treatment With Intra-Arterial Bevacizumab Injection

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Conditions

Chronic Subdural HematomaChronic intracranial subdural hematomaVascular endothelial growth factorBevacizumabMiddle meningeal artery embolization

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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?

Official Title

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

Quick Facts

Study Start:2024-06-17
Study Completion:2028-06-17
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06510582

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adult patients (≥18 years)
  2. * Radiographic evidence of chronic subdural hematoma, including
  3. 1. Persistence of subdural blood more than 10 days after index traumatic injury or event
  4. 2. Presence of mixed density blood
  5. 3. Presence of subdural membranes
  6. * Can obtain informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization.
  1. * Pregnant, breastfeeding, or unwilling to practice contraception during participation in the study.
  2. * Patients with concomitant intracranial pathology other than subdural hematoma (e.g., intracranial malignancy).
  3. * Patients with known hypersensitivity to bevacizumab.
  4. * Patients with radiographic evidence of mass effect.
  5. * Patients have focal neurological deficits attributed to subdural hematoma.
  6. * Patient had craniotomy or burr hole operative procedures performed in preceding two weeks prior to onset of subdural hematoma.
  7. * Secondary causes apart from trauma for the chronic subdural hematoma, such as underlying vascular abnormality or tumor.
  8. * Emergent surgical evacuation is required for the patient.
  9. * Non-convexity chronic subdural hematoma, as the middle meningeal artery will not supply this area.
  10. * Coagulation abnormalities, including platelet count \<100,000 and/or international normalized ratio of \<1.5 despite attempts for correction.
  11. * Patients with known contraindications for angiography. Patients with contrast allergy will be premedicated with diphenhydramine and steroids.
  12. * Patient has known active systemic infection or sepsis.
  13. * Patient has contradiction to anesthetic agents used for conscious sedation/monitored anesthesia care (MAC).
  14. * Patient has life expectancy of less than six months due to comorbid terminal conditions.
  15. * Patient has a premorbid modified Rankin score (mRS) of 5 or greater.
  16. * Concurrent participation in another research protocol for investigation of an experimental therapy.

Contacts and Locations

Study Contact

Thuy Cao
CONTACT
856-342-2689
cao-thuy@cooperhealth.edu

Principal Investigator

Jane Khalife, MD
PRINCIPAL_INVESTIGATOR
Cooper Neurological Institute
Ajith Thomas, MD
STUDY_DIRECTOR
Cooper Neurological Institute

Study Locations (Sites)

Cooper University Health Care
Camden, New Jersey, 08103
United States

Collaborators and Investigators

Sponsor: The Cooper Health System

  • Jane Khalife, MD, PRINCIPAL_INVESTIGATOR, Cooper Neurological Institute
  • Ajith Thomas, MD, STUDY_DIRECTOR, Cooper Neurological Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-17
Study Completion Date2028-06-17

Study Record Updates

Study Start Date2024-06-17
Study Completion Date2028-06-17

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Chronic Subdural Hematoma