急性大血管闭塞性卒中血管内治疗患者使用白蛋白的研究（ARISE）：一项随机双盲试验方案
Albumin for patients with acute large-vessel occlusive stroke undergoing endovascular therapy (ARISE): the protocol of a randomized double-blind trial.
作者信息
Liu Yuanyuan, Dong Xiao, Chu Xuehong, Ma Zhengfei, Yi Tingyu, Wen Changming, Liu Yifeng, Sun Jun, Xu Jing, Li Wenbo, Yang Lei, Wang Benxiao, Shi Lei, Li Jianqiao, Zhang Xiaoman, Li Chaoqun, Chen Wenhuo, Li Chuanhui, Wu Di, Hou Chengbei, Zhou Chen, Li Ming, Xu Yi, Wu Chuanjie, Ji Xunming
机构信息
Department of Neurology, Xuanwu Hospital of Capital Medical University, Beijing, China.
Department of Neurology, Suzhou Municipal Hospital, Suzhou, Anhui, China.
出版信息
Front Neurol. 2025 Jul 18;16:1570184. doi: 10.3389/fneur.2025.1570184. eCollection 2025.
BACKGROUND
Albumin is a multifunctional plasma protein that is mainly synthesized in the liver and may play a neuroprotective role in treating acute ischemic stroke (AIS). The efficacy of albumin in patients with AIS receiving reperfusion therapy remains unknown.
METHODS
ARISE is a multicenter, randomized, double-blind, placebo-controlled, phase 2 study. We will recruit 134 patients aged 18-80 years with AIS due to large-vessel occlusion in the anterior circulation, within 24 h of symptom onset, with an Alberta Stroke Program Early CT Score of 3-10 points and an infarct core volume of ≤100 mL at baseline. Eligible patients will be randomly assigned, on a 1:1 ratio, to undergo endovascular therapy (EVT) and receive albumin therapy (0.5 g/kg; intravenous injection) once daily for 4 days or to undergo EVT and receive placebo therapy once daily for 4 days. The primary efficacy outcome is the change in infarct volume from baseline to day 5.
CONCLUSION
The ARISE trial will provide valuable evidence on the efficacy and safety of albumin in patients with AIS receiving EVT.
CLINICAL TRIAL REGISTRATION
www.clinicaltrials.gov, NCT06538844.
背景
白蛋白是一种多功能血浆蛋白，主要在肝脏合成，可能在治疗急性缺血性卒中（AIS）中发挥神经保护作用。白蛋白对接受再灌注治疗的AIS患者的疗效尚不清楚。
方法
ARISE是一项多中心、随机、双盲、安慰剂对照的2期研究。我们将招募134例年龄在18 - 80岁之间、因前循环大血管闭塞导致AIS的患者，症状发作后24小时内，阿尔伯塔卒中项目早期CT评分为3 - 10分，基线时梗死核心体积≤100 mL。符合条件的患者将按1:1比例随机分配，接受血管内治疗（EVT），并接受白蛋白治疗（0.5 g/kg；静脉注射），每日1次，共4天，或接受EVT并接受安慰剂治疗，每日1次，共4天。主要疗效结局是从基线到第5天梗死体积的变化。
结论
ARISE试验将为白蛋白对接受EVT的AIS患者的疗效和安全性提供有价值的证据。
临床试验注册
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