Zhao Jingjing, Yang Fang, Song Changgeng, Li Li, Yang Xiai, Wang Xiaofeng, Yu Liping, Guo Jun, Wang Kangjun, Fu Feng, Jiang Wen
Department of Neurology, Xijing Hospital, Fourth Military Medical University (Air Force Medical University), Xi'an, China.
Department of Neurology, Ankang Central Hospital, Ankang, China.
Front Neurol. 2021 Apr 27;12:656520. doi: 10.3389/fneur.2021.656520. eCollection 2021.
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. 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. 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. 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. www.clinicaltrials.gov., NCT03741530. Registered on November 8, 2018. 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.
急性脑出血（ICH）后的脑水肿在ICH继发性损伤中起关键作用，可能会增加不良预后的可能性。本试验旨在探讨小剂量口服格列本脲对血肿周围水肿（PHE）的疗效及ICH患者的预后。GATE-ICH试验是一项多中心随机、对照、评估者盲法试验。中国28个研究中心的220例急性原发性ICH成年患者将被随机分为格列本脲组（格列本脲加指南推荐的ICH治疗）或对照组（指南推荐的ICH治疗）。将采用多变量逻辑回归分析治疗与主要结局之间的关系。主要疗效结局是入组后90天时功能预后不良（改良Rankin量表≥3）的比例。次要疗效结局包括基线和随访计算机断层扫描之间ICH和PHE体积的变化以及基线和随访评估之间的临床评分。GATE-ICH试验将评估小剂量口服格列本脲在减少ICH后PHE及改善患者90天预后方面的效果。www.clinicaltrials.gov，NCT03741530。于2018年11月8日注册。方案版本：2019年5月6日，第5版。患者招募和随访目前正在进行。本试验将于2021年第二季度结束。
