Abstract
Background
The conventional treatments for non-acute subdural hematoma (SDH) are facing the challenge of high hematoma recurrence and progression. A novel treatment of middle meningeal artery (MMA) embolization showed the potential role in decreasing the recurrence and progression rate of SDH compared to conventional treatments in multiple cohort studies. A randomized controlled trial is warranted to determine the effectiveness and safety of MMA embolization for non-acute hematoma and whether MMA embolization is superior to conventional treatments to lower the symptomatic recurrence and progression rate of non-acute SDH.
Methods
This is an investigator-initiated, multi-center, prospective, open-label parallel group trial with blinded outcome assessment (PROBE design) assessing superiority of MMA embolization compared to conventional treatments. A total of 722 patients are planned to be randomized 1:1 to receive MMA embolization (intervention) or conventional treatments (control). The primary outcome is the symptomatic SDH recurrence/progression rate within 90 ± 14 days post-randomization.
Discussion
This trial will clarify whether MMA embolization could reduce the recurrence or progression rate of symptomatic non-acute SDH compared to conventional treatment.
Trial registration
ClinicalTrials.gov. Identifier: NCT04700345, Registered on 7 January 2021.
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Details
1 Neurovascular Center, Changhai Hospital, Naval Medical University, Shanghai, China (GRID:grid.411525.6) (ISNI:0000 0004 0369 1599)
2 Huashan Hospital, Fudan University, Department of Neurosurgery, Shanghai, China (GRID:grid.411405.5) (ISNI:0000 0004 1757 8861)
3 Amsterdam University Medical Center, Location University of Amsterdam, Department of Radiology & Nuclear Medicine, Amsterdam, The Netherlands (GRID:grid.509540.d) (ISNI:0000 0004 6880 3010)
4 Hotchkiss Brain Institute, Cummings School of Medicine, University of Calgary, Departments of Clinical Neuroscience and Radiology, Calgary, Canada (GRID:grid.22072.35) (ISNI:0000 0004 1936 7697)