Albumin for patients with acute large-vessel occlusive stroke undergoing endovascular therapy (ARISE): the protocol of a randomized double-blind trial
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, randomi...
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Frontiers Media S.A.
2025-07-01
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| Series: | Frontiers in Neurology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fneur.2025.1570184/full |
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| author | Yuanyuan Liu Xiao Dong Xuehong Chu Zhengfei Ma Tingyu Yi Tingyu Yi Changming Wen Yifeng Liu Jun Sun Jing Xu Wenbo Li Lei Yang Benxiao Wang Lei Shi Jianqiao Li Xiaoman Zhang Chaoqun Li Wenhuo Chen Chuanhui Li Di Wu Chengbei Hou Chen Zhou Ming Li Ming Li Yi Xu Chuanjie Wu Xunming Ji Xunming Ji |
| author_facet | Yuanyuan Liu Xiao Dong Xuehong Chu Zhengfei Ma Tingyu Yi Tingyu Yi Changming Wen Yifeng Liu Jun Sun Jing Xu Wenbo Li Lei Yang Benxiao Wang Lei Shi Jianqiao Li Xiaoman Zhang Chaoqun Li Wenhuo Chen Chuanhui Li Di Wu Chengbei Hou Chen Zhou Ming Li Ming Li Yi Xu Chuanjie Wu Xunming Ji Xunming Ji |
| author_sort | Yuanyuan Liu |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-3ffedd5c2aea4738a1d6d72f2d31f1c3 |
| institution | DOAJ |
| issn | 1664-2295 |
| language | English |
| publishDate | 2025-07-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Neurology |
| spelling | doaj-art-3ffedd5c2aea4738a1d6d72f2d31f1c32025-08-20T02:41:02ZengFrontiers Media S.A.Frontiers in Neurology1664-22952025-07-011610.3389/fneur.2025.15701841570184Albumin for patients with acute large-vessel occlusive stroke undergoing endovascular therapy (ARISE): the protocol of a randomized double-blind trialYuanyuan Liu0Xiao Dong1Xuehong Chu2Zhengfei Ma3Tingyu Yi4Tingyu Yi5Changming Wen6Yifeng Liu7Jun Sun8Jing Xu9Wenbo Li10Lei Yang11Benxiao Wang12Lei Shi13Jianqiao Li14Xiaoman Zhang15Chaoqun Li16Wenhuo Chen17Chuanhui Li18Di Wu19Chengbei Hou20Chen Zhou21Ming Li22Ming Li23Yi Xu24Chuanjie Wu25Xunming Ji26Xunming Ji27Department of Neurology, Xuanwu Hospital of Capital Medical University, Beijing, ChinaDepartment of Neurology, Xuanwu Hospital of Capital Medical University, Beijing, ChinaDepartment of Neurology, Xuanwu Hospital of Capital Medical University, Beijing, ChinaDepartment of Neurology, Suzhou Municipal Hospital, Suzhou, Anhui, ChinaDepartment of Neuro-intervention, Zhangzhou Municipal Hospital, Zhangzhou, Fujian, ChinaDepartment of Neuro-intervention, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou, Fujian, ChinaDepartment of Neurology, Nanyang Central Hospital, Nanyang, Henan, ChinaDepartment of Neurology, Nanyang Central Hospital, Nanyang, Henan, ChinaDepartment of Neurology, Nanyang Central Hospital, Nanyang, Henan, ChinaDepartment of Neurology, Maanshan People's Hospital, Maanshan, Anhui, ChinaDepartment of Neurology, Luoyang Central Hospital Affiliated To Zhengzhou University, Luoyang, Henan, ChinaDepartment of Neurology, Liaocheng Third People's Hospital, Liaocheng, Shandong, ChinaDepartment of Neurology, WanBei Coal-Electricity Group General Hospital, Suzhou, Anhui, China0Department of Neurology, Si County People's Hospital, Anhui, China1Department of Neurology, Sui Xi County Hospital, Huaibei, Anhui, China2Department of Neurology, The First People’s Hospital of Zhengzhou, Zhengzhou, Henan, China3Department of Neurology, Xihua County People's Hospital, Zhoukou, Henan, China4Department of Cerebrovascular Disease, Fujian Medical University Union Hospital, Fujian, ChinaDepartment of Neurology, Xuanwu Hospital of Capital Medical University, Beijing, China5China-America Institute of Neuroscience and Beijing Institute of Geriatrics, Xuanwu Hospital, Capital Medical University, Beijing, China6Center for Evidence Based Medicine, Xuanwu Hospital, Capital Medical University, Beijing, China7Beijing Institute for Brain Disorders, Capital Medical University, Beijing, China5China-America Institute of Neuroscience and Beijing Institute of Geriatrics, Xuanwu Hospital, Capital Medical University, Beijing, China7Beijing Institute for Brain Disorders, Capital Medical University, Beijing, ChinaDepartment of Neurology, Xuanwu Hospital of Capital Medical University, Beijing, ChinaDepartment of Neurology, Xuanwu Hospital of Capital Medical University, Beijing, ChinaDepartment of Neurology, Xuanwu Hospital of Capital Medical University, Beijing, China7Beijing Institute for Brain Disorders, Capital Medical University, Beijing, ChinaBackgroundAlbumin 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.https://www.frontiersin.org/articles/10.3389/fneur.2025.1570184/fullalbuminneuroprotectionendovascular therapyacute ischemic stroke |
| spellingShingle | Yuanyuan Liu Xiao Dong Xuehong Chu Zhengfei Ma Tingyu Yi Tingyu Yi Changming Wen Yifeng Liu Jun Sun Jing Xu Wenbo Li Lei Yang Benxiao Wang Lei Shi Jianqiao Li Xiaoman Zhang Chaoqun Li Wenhuo Chen Chuanhui Li Di Wu Chengbei Hou Chen Zhou Ming Li Ming Li Yi Xu Chuanjie Wu Xunming Ji Xunming Ji Albumin for patients with acute large-vessel occlusive stroke undergoing endovascular therapy (ARISE): the protocol of a randomized double-blind trial Frontiers in Neurology albumin neuroprotection endovascular therapy acute ischemic stroke |
| title | Albumin for patients with acute large-vessel occlusive stroke undergoing endovascular therapy (ARISE): the protocol of a randomized double-blind trial |
| title_full | Albumin for patients with acute large-vessel occlusive stroke undergoing endovascular therapy (ARISE): the protocol of a randomized double-blind trial |
| title_fullStr | Albumin for patients with acute large-vessel occlusive stroke undergoing endovascular therapy (ARISE): the protocol of a randomized double-blind trial |
| title_full_unstemmed | Albumin for patients with acute large-vessel occlusive stroke undergoing endovascular therapy (ARISE): the protocol of a randomized double-blind trial |
| title_short | Albumin for patients with acute large-vessel occlusive stroke undergoing endovascular therapy (ARISE): the protocol of a randomized double-blind trial |
| title_sort | albumin for patients with acute large vessel occlusive stroke undergoing endovascular therapy arise the protocol of a randomized double blind trial |
| topic | albumin neuroprotection endovascular therapy acute ischemic stroke |
| url | https://www.frontiersin.org/articles/10.3389/fneur.2025.1570184/full |
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