STUDY PROTOCOL article
Front. Neurol.
Sec. Stroke
Volume 16 - 2025 | doi: 10.3389/fneur.2025.1570184
The type of manuscript: Protocol Albumin for Patients with Acute Large Vessel Occlusive Stroke Undergoing Endovascular Therapy (ARISE): protocol of a randomized double-blind trial
Provisionally accepted
Xunming JI1*
Yuanyuan Liu1Xiao Dong1Xuehong Chu1Zhengfei Ma2
Ting-yu Yi3
Changming Wen4Yifeng Liu4Jun Sun4
Jing Xu5Wenbo Li6Lei Yang7Benxiao Wang8Lei Shi9Jianqiao Li10Xiaoman Zhang11Chaoqun Li12
Wenhuo Chen13Chuanhui Li1
Di Wu1
Chengbei Hou1
Chen Zhou14Ming Li1Yi Xu1Chuanjie Wu1,14*- 1Xuanwu Hospital, Capital Medical University, Beijing, China
- 2Department of Neurology, Suzhou Municipal Hospital, Suzhou, Liaoning Province, China
- 3Zhangzhou Municipal Hospital, Zhangzhou, China
- 4Nanyang City Center Hospital, Nanyang, China
- 5Ma'anshan People's Hospital, Ma Anshan, China
- 6Luoyang Central Hospital Affiliated to Zhengzhou University, Luoyang, Henan Province, China
- 7Liaocheng Third People’s Hospital, Liaocheng, Shandong Province, China
- 8Wanbei Coal and Electricity Group General Hospital, Anhui, Anhui, China
- 9Si County People's Hospital, Anhui, Anhui Province, China
- 10Sui Xi County Hospital, Anhui, China
- 11Zhengzhou First People's Hospital, Zhengzhou, Henan Province, China
- 12Xihua County People's Hospital, Henan, China
- 13Fujian Medical University Union Hospital, Fuzhou, Fujian Province, China
- 14Beijing Institute for Brain Disorders, Capital Medical University, Beijing, Beijing Municipality, China
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Background: Albumin is a multifunctional plasma protein that is mainly synthesized in the liver and may play a neuroprotective role for treating acute ischemic stroke (AIS). The efficacy of albumin in patients with AIS receiving reperfusion therapy remains unknown.Methods: ARISE is a multicentre, 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 hours from symptom onset, with an Alberta Stroke Program Early CT Score of 3-10 points and infarct core volume ≤100 ml at baseline. Eligible patients will be randomly assigned, on a 1:1 ratio, to undergoing endovascular thrombectomy (EVT) and receive albumin therapy (0.5g/kg; intravenously injection) once daily for 4 days or to undergoing 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.The ARISE trial will provide valuable evidence on the efficacy and safety of albumin in patients with AIS receiving EVT.
Keywords: albumin, Neuroprotection, Endovascular Therapy, Acute ischemic stroke Trial registration: ClinicalTrials.gov, NCT06538844
Received: 03 Feb 2025; Accepted: 24 Jun 2025.
Copyright: © 2025 JI, Liu, Dong, Chu, Ma, Yi, Wen, Liu, Sun, Xu, Li, Yang, Wang, Shi, Li, Zhang, Li, Chen, Li, Wu, Hou, Zhou, Li, Xu and Wu. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence:
Xunming JI, Xuanwu Hospital, Capital Medical University, Beijing, China
Chuanjie Wu, Xuanwu Hospital, Capital Medical University, Beijing, China
Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.