Chronic Subdural Hematoma Treatment With Intra-Arterial Bevacizumab Injection
ConditionChronic Subdural Hematoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Cooper Health System
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Bevacizumab 2 mg/kg
DrugSingle 2mg/kg dose of bevacizumab to treat unilateral cSDH
Bevacizumab 4 mg/kg
DrugTwo 2mg/kg doses (cumulatively 4mg/kg) of bevacizumab to treat bilateral cSDH
Treatment groups
140 Participants
are divided into 4 treatment groupsGroup A: Phase 1 Unilateral cSDH/ 2mg/kg ArmExperimental treatment 1 intervention
Group B: Phase 1 Bilateral cSDH/ 4mg/kg ArmExperimental treatment 1 intervention
Group C: Phase 2 Unilateral cSDH/ 2mg/kg ArmExperimental treatment 1 intervention
Group D: Phase 2 Bilateral cSDH/ 4mg/kg ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of Participants with Serious Adverse Events
Reported serious adverse events classified using MedDRA and CTCAE, in addition to treatment-related events and all other adverse events
Time frame
Up to 3 months after study treatmentSecondary outcomes
1
Rate of Hematoma Recurrence
Rate of hematoma recurrence or progression requiring intervention and/or readmission
Time frame
3 months after study treatment and 6 months after study treatment2
Rate of Complete Hematoma Resolution
Rate of complete hematoma resolution compared to baseline on imaging
Time frame
3 months after study treatment and 6 months after study treatment3
Rate of Partial Hematoma Resolution
Rate of at least 50% or greater reduction in hematoma size from baseline on imaging
Time frame
3 months after study treatment and 6 months after study treatment4
Change in Hematoma Size
Change in hematoma size measured in millimeters on imaging
Time frame
3 months after study treatment and 6 months after study treatmentOther outcomes
1
Number of Participants with Anatomical Variants
Middle meningeal arteries with dangerous anastomoses observed on imaging
Time frame
During the treatment procedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
The Cooper Health System
Lead sponsor
Society of Vascular and Interventional Neurology
Collaborator
Source ClinicalTrials.gov