Chronic Subdural Hematoma Treatment With Intra-Arterial Bevacizumab Injection
Recruiting
Phase 1Phase 2Interventional Study
Chronic Subdural Hematoma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
140 (estimated)
Sponsor
The Cooper Health System · Other
Who this trial is looking for
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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?
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
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…
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.
Contacts
No contact information available.
What are you hoping to find?
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.