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New treatment option for Chronic Subdural Hematoma
Official title Chronic Subdural Hematoma Treatment With Intra-Arterial Bevacizumab Injection
ClinicalTrials.gov ID: NCT06510582
What this study is testing
What is Bevacizumab 2 mg/kg?
Bevacizumab 2 mg/kg is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for chronic subdural hematoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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
You likely can't join 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.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Camden, New Jersey, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Camden, New Jersey, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.