TY - JOUR
T1 - Managing non-acute subdural hematoma using liquid materials
T2 - a Chinese randomized trial of middle meningeal artery treatment (MAGIC-MT)—protocol
AU - Zuo, Qiao
AU - Ni, Wei
AU - Yang, Pengfei
AU - Gu, Yuxiang
AU - Yu, Ying
AU - Yang, Heng
AU - Majoie, Charles B. L. M.
AU - Goyal, Mayank
AU - Liu, Jianmin
AU - Mao, Ying
N1 - Funding Information:
This trial is supported by Shanghai Shenkang Hospital Development Center (SHDC2020CR1018B), Changhai Hospital (2020YSL004), Shanghai Municipal Health Commission (2023–62), and Covidien/Medtronic (20212016387–01/1). The funding source had no role in the design of the study, collection of data, data management, analyses, interpretation of data, writing the manuscript, or publication of the results.
Publisher Copyright:
© 2023, BioMed Central Ltd., part of Springer Nature.
PY - 2023/12/1
Y1 - 2023/12/1
N2 - 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.
AB - 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.
KW - Chronic subdural hematoma
KW - Embolization
KW - Middle meningeal artery
KW - Progression
KW - Recurrence
KW - Sub-acute subdural hematoma
UR - https://www.scopus.com/pages/publications/85171374719
U2 - 10.1186/s13063-023-07608-2
DO - 10.1186/s13063-023-07608-2
M3 - Article
C2 - 37710274
SN - 1745-6215
VL - 24
JO - Trials
JF - Trials
IS - 1
M1 - 586
ER -