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Managing non-acute subdural hematoma using liquid materials: a Chinese randomized trial of middle meningeal artery
Qiao Zuo1, Wei Ni2, Pengfei Yang1
1Neurovascular Center, Changhai Hospital, Naval Medical University, Shanghai, China.
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.
