Zuo, QiaoNi, WeiYang, PengfeiGu, YuxiangYu, YingYang, HengMajoie, Charles B. L. M.Goyal, MayankLiu, JianminMao, Ying2023-09-172023-09-172023-09-14Trials. 2023 Sep 14;24(1):586https://doi.org/10.1186/s13063-023-07608-2https://hdl.handle.net/1880/117081https://doi.org/10.11575/PRISM/41925Abstract 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.Journal Article2023-09-17enBioMed Central Ltd., part of Springer Nature