AUTHOR=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 

TITLE=Albumin for patients with acute large-vessel occlusive stroke undergoing endovascular therapy (ARISE): the protocol of a randomized double-blind trial

JOURNAL=Frontiers in Neurology

VOLUME=Volume 16 - 2025

YEAR=2025

URL=https://www.frontiersin.org/journals/neurology/articles/10.3389/fneur.2025.1570184

DOI=10.3389/fneur.2025.1570184

ISSN=1664-2295

ABSTRACT=BackgroundAlbumin 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.MethodsARISE 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.ConclusionThe ARISE trial will provide valuable evidence on the efficacy and safety of albumin in patients with AIS receiving EVT.Clinical trial registrationwww.clinicaltrials.gov, NCT06538844.