Intra-arterial selective hypothermia for acute ischemic stroke neuroprotection: A multicenter pilot trial in China

作者：Zhixin Huang, Miaomiao Hu, Pan Zhang, Xuying He, Xinan Ma, Quanlong Hong, Ping Chen, Huanhuan Luan, Zongyi Wu, Chaolai Liu, Wei Li, Yongkun Li, Yongtao Yu, Man Li, Yajun Li, Dezhi Liu, Zhongkui Han, Weiliang Shi, Jilong Yi, Liang Liu, Guoqiang Xu, Haike Lu, Lizhi Zhou, Xinfeng Liu, Wen Sun, For the ISOLATION Group · 发表于：PLoS Medicine · 年份：2025 · DOI：10.1371/journal.pmed.1004668 · 被引用次数：9 · 研究领域：Acute Ischemic Stroke Management、Thermal Regulation in Medicine、Traumatic Brain Injury and Neurovascular Disturbances

BACKGROUND: Acute ischemic stroke (AIS) remains a leading cause of disability and death globally, with limited effective neuroprotective strategies beyond reperfusion therapies. Despite advances in reperfusion treatments, many patients still experience poor outcomes, highlighting the urgent need for additional therapeutic approaches. We investigated whether intra-arterial local therapeutic hypothermia (IA-LTH) combined with endovascular treatment could improve outcomes in patients with AIS. METHODS AND FINDINGS: We conducted a multicenter, randomized trial with blinded outcome assessment (ISOLATION trial), where outcome assessors and patients were blinded to treatment allocation while procedural staff could not be blinded, to test the effectiveness of IA-LTH for neuroprotection in AIS (registration number: ChiCTR2300074990). Between September 2023 and January 2024, we recruited 100 patients with anterior circulation large vessel occlusion within 24 h of stroke onset from 18 stroke centers in China. Participants were randomly assigned (1:1) to receive either IA-LTH plus standard care (including endovascular treatment and guideline-recommended medical therapy; intervention; n = 50) or standard care alone (control; n = 50). The IA-LTH group received intra-arterial infusion of 4 °C saline during and following endovascular treatment. Primary outcome was favorable functional outcome (modified Rankin Scale 0-2) at 90 days. Using intention-to-treat analysis, among participants (media...