Skip to Main Content

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

Principal Investigator

Sub-Investigator

For more information about this study, contact:

Or contact the Help us Discover team on: