Glibenclamide Advantage in Treating Edema After Intracerebral Hemorrhage (GATE-ICH): Study Protocol for a Multicenter Randomized, Controlled, Assessor-Blinded Trial
Introduction: Brain edema after acute intracerebral hemorrhage (ICH) plays a critical role in the secondary injury of ICH and may heighten the potential for a poor outcome. This trial aims to explore the efficacy of small doses of oral glibenclamide in perihematomal edema (PHE) and the prognosis of...
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Frontiers Media S.A.
2021-04-01
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| Series: | Frontiers in Neurology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fneur.2021.656520/full |
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| author | Jingjing Zhao Fang Yang Changgeng Song Li Li Xiai Yang Xiaofeng Wang Liping Yu Jun Guo Kangjun Wang Feng Fu Wen Jiang |
| author_facet | Jingjing Zhao Fang Yang Changgeng Song Li Li Xiai Yang Xiaofeng Wang Liping Yu Jun Guo Kangjun Wang Feng Fu Wen Jiang |
| author_sort | Jingjing Zhao |
| collection | DOAJ |
| description | Introduction: Brain edema after acute intracerebral hemorrhage (ICH) plays a critical role in the secondary injury of ICH and may heighten the potential for a poor outcome. This trial aims to explore the efficacy of small doses of oral glibenclamide in perihematomal edema (PHE) and the prognosis of patients with ICH.Methods and Analysis: The GATE-ICH trial is a multicenter randomized, controlled, assessor-blinded trial. A total of 220 adult patients with acute primary ICH in 28 study centers in China will be randomized to the glibenclamide group (glibenclamide plus guideline-recommended ICH management) or the control group (guideline-recommended ICH management). Multivariate logistic regression will be used to analyze the relationship between the treatments and primary outcome.Study Outcomes: The primary efficacy outcome is the proportion of poor functional outcomes (modified Rankin Scale ≥3) at 90 days after enrollment. The secondary efficacy outcomes include changes in the volume of ICH and PHE between the baseline and follow-up computed tomography scans as well as the clinical scores between the baseline and follow-up assessments.Discussion: The GATE-ICH trial will assess the effects of small doses of oral glibenclamide in reducing the PHE after ICH and improving the 90-day prognosis of patients.Clinical Trial Registration:www.clinicaltrials.gov., NCT03741530. Registered on November 8, 2018.Trial Status: Protocol version: May 6, 2019, Version 5. Recruitment and follow-up of patients is currently ongoing. This trial will be end in the second quarter of 2021. |
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| last_indexed | 2024-12-19T01:15:32Z |
| publishDate | 2021-04-01 |
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| series | Frontiers in Neurology |
| spelling | doaj.art-884e46646f46445c8e2be53d777b360a2022-12-21T20:42:43ZengFrontiers Media S.A.Frontiers in Neurology1664-22952021-04-011210.3389/fneur.2021.656520656520Glibenclamide Advantage in Treating Edema After Intracerebral Hemorrhage (GATE-ICH): Study Protocol for a Multicenter Randomized, Controlled, Assessor-Blinded TrialJingjing Zhao0Fang Yang1Changgeng Song2Li Li3Xiai Yang4Xiaofeng Wang5Liping Yu6Jun Guo7Kangjun Wang8Feng Fu9Wen Jiang10Department of Neurology, Xijing Hospital, Fourth Military Medical University (Air Force Medical University), Xi'an, ChinaDepartment of Neurology, Xijing Hospital, Fourth Military Medical University (Air Force Medical University), Xi'an, ChinaDepartment of Neurology, Xijing Hospital, Fourth Military Medical University (Air Force Medical University), Xi'an, ChinaDepartment of Neurology, Xijing Hospital, Fourth Military Medical University (Air Force Medical University), Xi'an, ChinaDepartment of Neurology, Ankang Central Hospital, Ankang, ChinaDepartment of Neurosurgery, The PLA 987 Hospital, Baoji, ChinaDepartment of Neurology, The First Peoples Hospital of Xianyang, Xianyang, ChinaDepartment of Neurology, Tangdu Hospital, Fourth Military Medical University (Air Force Medical University), Xi'an, ChinaDepartment of Neurology, Hanzhong Central Hospital, Hanzhong, ChinaDepartment of Neurology, 215 Hospital of Shaanxi NI, Xianyang, ChinaDepartment of Neurology, Xijing Hospital, Fourth Military Medical University (Air Force Medical University), Xi'an, ChinaIntroduction: Brain edema after acute intracerebral hemorrhage (ICH) plays a critical role in the secondary injury of ICH and may heighten the potential for a poor outcome. This trial aims to explore the efficacy of small doses of oral glibenclamide in perihematomal edema (PHE) and the prognosis of patients with ICH.Methods and Analysis: The GATE-ICH trial is a multicenter randomized, controlled, assessor-blinded trial. A total of 220 adult patients with acute primary ICH in 28 study centers in China will be randomized to the glibenclamide group (glibenclamide plus guideline-recommended ICH management) or the control group (guideline-recommended ICH management). Multivariate logistic regression will be used to analyze the relationship between the treatments and primary outcome.Study Outcomes: The primary efficacy outcome is the proportion of poor functional outcomes (modified Rankin Scale ≥3) at 90 days after enrollment. The secondary efficacy outcomes include changes in the volume of ICH and PHE between the baseline and follow-up computed tomography scans as well as the clinical scores between the baseline and follow-up assessments.Discussion: The GATE-ICH trial will assess the effects of small doses of oral glibenclamide in reducing the PHE after ICH and improving the 90-day prognosis of patients.Clinical Trial Registration:www.clinicaltrials.gov., NCT03741530. Registered on November 8, 2018.Trial Status: Protocol version: May 6, 2019, Version 5. Recruitment and follow-up of patients is currently ongoing. This trial will be end in the second quarter of 2021.https://www.frontiersin.org/articles/10.3389/fneur.2021.656520/fullperihematomal edemaintracerebral hemorrhageglibenclamideprognosisclinical trial |
| spellingShingle | Jingjing Zhao Fang Yang Changgeng Song Li Li Xiai Yang Xiaofeng Wang Liping Yu Jun Guo Kangjun Wang Feng Fu Wen Jiang Glibenclamide Advantage in Treating Edema After Intracerebral Hemorrhage (GATE-ICH): Study Protocol for a Multicenter Randomized, Controlled, Assessor-Blinded Trial Frontiers in Neurology perihematomal edema intracerebral hemorrhage glibenclamide prognosis clinical trial |
| title | Glibenclamide Advantage in Treating Edema After Intracerebral Hemorrhage (GATE-ICH): Study Protocol for a Multicenter Randomized, Controlled, Assessor-Blinded Trial |
| title_full | Glibenclamide Advantage in Treating Edema After Intracerebral Hemorrhage (GATE-ICH): Study Protocol for a Multicenter Randomized, Controlled, Assessor-Blinded Trial |
| title_fullStr | Glibenclamide Advantage in Treating Edema After Intracerebral Hemorrhage (GATE-ICH): Study Protocol for a Multicenter Randomized, Controlled, Assessor-Blinded Trial |
| title_full_unstemmed | Glibenclamide Advantage in Treating Edema After Intracerebral Hemorrhage (GATE-ICH): Study Protocol for a Multicenter Randomized, Controlled, Assessor-Blinded Trial |
| title_short | Glibenclamide Advantage in Treating Edema After Intracerebral Hemorrhage (GATE-ICH): Study Protocol for a Multicenter Randomized, Controlled, Assessor-Blinded Trial |
| title_sort | glibenclamide advantage in treating edema after intracerebral hemorrhage gate ich study protocol for a multicenter randomized controlled assessor blinded trial |
| topic | perihematomal edema intracerebral hemorrhage glibenclamide prognosis clinical trial |
| url | https://www.frontiersin.org/articles/10.3389/fneur.2021.656520/full |
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