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

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 compa...

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Autores principales: Zuo, Qiao, Ni, Wei, Yang, Pengfei, Gu, Yuxiang, Yu, Ying, Yang, Heng, Majoie, Charles B. L. M., Goyal, Mayank, Liu, Jianmin, Mao, Ying
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10503047/
https://www.ncbi.nlm.nih.gov/pubmed/37710274
http://dx.doi.org/10.1186/s13063-023-07608-2
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author Zuo, Qiao
Ni, Wei
Yang, Pengfei
Gu, Yuxiang
Yu, Ying
Yang, Heng
Majoie, Charles B. L. M.
Goyal, Mayank
Liu, Jianmin
Mao, Ying
author_facet Zuo, Qiao
Ni, Wei
Yang, Pengfei
Gu, Yuxiang
Yu, Ying
Yang, Heng
Majoie, Charles B. L. M.
Goyal, Mayank
Liu, Jianmin
Mao, Ying
author_sort Zuo, Qiao
collection PubMed
description 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. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-023-07608-2.
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spelling pubmed-105030472023-09-16 Managing non-acute subdural hematoma using liquid materials: a Chinese randomized trial of middle meningeal artery treatment (MAGIC-MT)—protocol Zuo, Qiao Ni, Wei Yang, Pengfei Gu, Yuxiang Yu, Ying Yang, Heng Majoie, Charles B. L. M. Goyal, Mayank Liu, Jianmin Mao, Ying Trials Study Protocol 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. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-023-07608-2. BioMed Central 2023-09-14 /pmc/articles/PMC10503047/ /pubmed/37710274 http://dx.doi.org/10.1186/s13063-023-07608-2 Text en © The Author(s) 2023 https://creativecommons.org/licenses/by/4.0/Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Study Protocol
Zuo, Qiao
Ni, Wei
Yang, Pengfei
Gu, Yuxiang
Yu, Ying
Yang, Heng
Majoie, Charles B. L. M.
Goyal, Mayank
Liu, Jianmin
Mao, Ying
Managing non-acute subdural hematoma using liquid materials: a Chinese randomized trial of middle meningeal artery treatment (MAGIC-MT)—protocol
title Managing non-acute subdural hematoma using liquid materials: a Chinese randomized trial of middle meningeal artery treatment (MAGIC-MT)—protocol
title_full Managing non-acute subdural hematoma using liquid materials: a Chinese randomized trial of middle meningeal artery treatment (MAGIC-MT)—protocol
title_fullStr Managing non-acute subdural hematoma using liquid materials: a Chinese randomized trial of middle meningeal artery treatment (MAGIC-MT)—protocol
title_full_unstemmed Managing non-acute subdural hematoma using liquid materials: a Chinese randomized trial of middle meningeal artery treatment (MAGIC-MT)—protocol
title_short Managing non-acute subdural hematoma using liquid materials: a Chinese randomized trial of middle meningeal artery treatment (MAGIC-MT)—protocol
title_sort managing non-acute subdural hematoma using liquid materials: a chinese randomized trial of middle meningeal artery treatment (magic-mt)—protocol
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10503047/
https://www.ncbi.nlm.nih.gov/pubmed/37710274
http://dx.doi.org/10.1186/s13063-023-07608-2
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