Managing non-acute subdural hematoma using liquid materials: a Chinese randomized trial of middle meningeal artery treatment (MAGIC-MT)—protocol

Trials

Study Protocol

Yuxiang Gu¹  Ying Mao¹  Heng Yang¹  Wei Ni¹  Charles B. L. M. Majoie²  Mayank Goyal³  Qiao Zuo⁴  Ying Yu⁴  Pengfei Yang⁴  Jianmin Liu⁴ 

[1] Department of Neurosurgery, Huashan Hospital, Fudan University, Shanghai, China;Department of Radiology & Nuclear Medicine, Amsterdam University Medical Center, Location University of Amsterdam, Amsterdam, The Netherlands;Departments of Clinical Neuroscience and Radiology, Hotchkiss Brain Institute, Cummings School of Medicine, University of Calgary, Calgary, AB, Canada;Neurovascular Center, Changhai Hospital, Naval Medical University, Shanghai, China;

关键词: Chronic subdural hematoma;    Sub-acute subdural hematoma;    Middle meningeal artery;    Embolization;    Recurrence;    Progression;   

DOI  :  10.1186/s13063-023-07608-2

 received in 2023-05-21, accepted in 2023-08-28,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundThe 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.MethodsThis 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.DiscussionThis trial will clarify whether MMA embolization could reduce the recurrence or progression rate of symptomatic non-acute SDH compared to conventional treatment.Trial registrationClinicalTrials.gov. Identifier: NCT04700345, Registered on 7 January 2021.

【 授权许可】

CC BY   
© BioMed Central Ltd., part of Springer Nature 2023

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