Managing non-acute subdural hematoma using liquid materials: a Chinese randomized trial of middle meningeal artery treatment (MAGIC-MT)—protocol
Abstract 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 S...
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| Format: | Article |
| Language: | English |
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BMC
2023-09-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-023-07608-2 |
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| author | Qiao Zuo Wei Ni Pengfei Yang Yuxiang Gu Ying Yu Heng Yang Charles B. L. M. Majoie Mayank Goyal Jianmin Liu Ying Mao on behalf of MAGIC-MT investigators |
| author_facet | Qiao Zuo Wei Ni Pengfei Yang Yuxiang Gu Ying Yu Heng Yang Charles B. L. M. Majoie Mayank Goyal Jianmin Liu Ying Mao on behalf of MAGIC-MT investigators |
| author_sort | Qiao Zuo |
| collection | DOAJ |
| description | Abstract 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. |
| first_indexed | 2024-03-10T17:05:58Z |
| format | Article |
| id | doaj.art-73d48fa6a814412492135fb369da639e |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-03-10T17:05:58Z |
| publishDate | 2023-09-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-73d48fa6a814412492135fb369da639e2023-11-20T10:48:50ZengBMCTrials1745-62152023-09-012411910.1186/s13063-023-07608-2Managing non-acute subdural hematoma using liquid materials: a Chinese randomized trial of middle meningeal artery treatment (MAGIC-MT)—protocolQiao Zuo0Wei Ni1Pengfei Yang2Yuxiang Gu3Ying Yu4Heng Yang5Charles B. L. M. Majoie6Mayank Goyal7Jianmin Liu8Ying Mao9on behalf of MAGIC-MT investigatorsNeurovascular Center, Changhai Hospital, Naval Medical UniversityDepartment of Neurosurgery, Huashan Hospital, Fudan UniversityNeurovascular Center, Changhai Hospital, Naval Medical UniversityDepartment of Neurosurgery, Huashan Hospital, Fudan UniversityNeurovascular Center, Changhai Hospital, Naval Medical UniversityDepartment of Neurosurgery, Huashan Hospital, Fudan UniversityDepartment of Radiology & Nuclear Medicine, Amsterdam University Medical Center, Location University of AmsterdamDepartments of Clinical Neuroscience and Radiology, Hotchkiss Brain Institute, Cummings School of Medicine, University of CalgaryNeurovascular Center, Changhai Hospital, Naval Medical UniversityDepartment of Neurosurgery, Huashan Hospital, Fudan UniversityAbstract 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.https://doi.org/10.1186/s13063-023-07608-2Chronic subdural hematomaSub-acute subdural hematomaMiddle meningeal arteryEmbolizationRecurrenceProgression |
| spellingShingle | Qiao Zuo Wei Ni Pengfei Yang Yuxiang Gu Ying Yu Heng Yang Charles B. L. M. Majoie Mayank Goyal Jianmin Liu Ying Mao on behalf of MAGIC-MT investigators Managing non-acute subdural hematoma using liquid materials: a Chinese randomized trial of middle meningeal artery treatment (MAGIC-MT)—protocol Trials Chronic subdural hematoma Sub-acute subdural hematoma Middle meningeal artery Embolization Recurrence Progression |
| 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 | Chronic subdural hematoma Sub-acute subdural hematoma Middle meningeal artery Embolization Recurrence Progression |
| url | https://doi.org/10.1186/s13063-023-07608-2 |
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