Middle Meningeal Artery Embolization for the Treatment of Subdural Hematomas With TRUFILL® n-BCA (MEMBRANE)
- Study HIC#:2000030366
- Last Updated:11/16/2021
This is a prospective, multi-center, open-label, randomized controlled study in which subjects can receive standard of care (SOC) alone or SOC and TRUFILL n-BCA MMA embolization for the treatment of chronic subdural hematomas (cSDH).
- Age18 years - 90 years
- GenderBoth
- Start Date11/09/2021
- End Date05/31/2024
Trial Purpose and Description
This is a prospective, multi-center, open-label, randomized controlled study in which subjects can receive standard of care (SOC) alone or SOC and TRUFILL n-BCA MMA embolization for the treatment of chronic subdural hematomas (cSDH).
Eligibility Criteria
Inclusion Criteria:
- Pre-randomization mRS </= 3
- Confirmed diagnosis of chronic subdural hematoma
- Completed informed consent
Exclusion Criteria:
- Acute subdural hematoma
- Prior treatment of target subdural hematoma
- Markwalder assessment >/= 3
- Glasgow Coma Scale < 9
- Presumed microbial superinfection
- CT or MRI evidence of intracranial tumor or mass lesion
- Life expectancy < 1 year
- Women who are pregnant, lactating, or who are of childbearing age and plan on becoming pregnant during the study
- Current involvement in another clinical trial that may confound study endpoints