Nanxing Wang, Meiyang Zhang, Mo Yang, Wenqian Liu, Weiming Liu, Yunwei Ou, Mengyuan Zhou, Xuan Wang, Zhiwei Sun, Yuesong Pan, Yongjun Wang, Yilong Wang
{"title":"Y-3骨内注射与静脉注射治疗急性大半球梗死的疗效和安全性（SOLUTION-2）：一项多中心、前瞻性、随机、开放标签、盲终点（PROBE）试验的基本原理和设计。","authors":"Nanxing Wang, Meiyang Zhang, Mo Yang, Wenqian Liu, Weiming Liu, Yunwei Ou, Mengyuan Zhou, Xuan Wang, Zhiwei Sun, Yuesong Pan, Yongjun Wang, Yilong Wang","doi":"10.1136/svn-2024-004011","DOIUrl":null,"url":null,"abstract":"<p><strong>Rationale: </strong>The blood-brain barrier (BBB) largely restricts the efficacy of neuroprotectants, which is an important approach in treating large hemispheric infarction (LHI). In this study, we harnessed intracalvariosseous (ICO) injection to bypass the BBB and facilitate drug delivery.</p><p><strong>Aim: </strong>To compare the efficacy and safety of ICO injection versus intravenous injection in the treatment of acute LHI within 24 hours of disease onset.</p><p><strong>Methods and design: </strong>The efficacy and safety of Y-3 ICO injection versus intravenous injection in the treatment of acute LHI (SOLUTION-2) is a multicentre, prospective, randomised, open-label, blind endpoint trial. 134 patients with acute LHI from more than six centres will be enrolled and randomised in the trial to receive ICO or intravenous injection of Y-3 in a 1:1 ratio.</p><p><strong>Study outcomes: </strong>The primary efficacy outcome is the proportion of patients with a modified Rankin Scale score of 0-3 at 90 days after symptom onset. Primary safety outcomes include infection events related to ICO injection procedures.</p><p><strong>Discussion: </strong>Results from the SOLUTION-2 trial will contribute to the understanding of the efficacy and safety of the Y-3 ICO injection in patients with LHI.</p><p><strong>Trial registry: </strong>The efficacy and safety of Y-3 ICO injection versus intravenous injection in the treatment of acute LHI (SOLUTION-2). URL: https://clinicaltrials.gov/study/NCT06374667?cond=SOLUTION-2&intr=y-3&rank=1.</p><p><strong>Trial registration number: </strong>NCT06374667.</p>","PeriodicalId":48733,"journal":{"name":"Journal of Investigative Medicine","volume":" ","pages":""},"PeriodicalIF":2.6000,"publicationDate":"2025-06-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Efficacy and safety of Y-3 intracalvariosseous injection versus intravenous injection in the treatment of acute large hemispheric infarction (SOLUTION-2): rationale and design of a multicentre, prospective, randomised, open-label, blind endpoint (PROBE) trial.\",\"authors\":\"Nanxing Wang, Meiyang Zhang, Mo Yang, Wenqian Liu, Weiming Liu, Yunwei Ou, Mengyuan Zhou, Xuan Wang, Zhiwei Sun, Yuesong Pan, Yongjun Wang, Yilong Wang\",\"doi\":\"10.1136/svn-2024-004011\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Rationale: </strong>The blood-brain barrier (BBB) largely restricts the efficacy of neuroprotectants, which is an important approach in treating large hemispheric infarction (LHI). In this study, we harnessed intracalvariosseous (ICO) injection to bypass the BBB and facilitate drug delivery.</p><p><strong>Aim: </strong>To compare the efficacy and safety of ICO injection versus intravenous injection in the treatment of acute LHI within 24 hours of disease onset.</p><p><strong>Methods and design: </strong>The efficacy and safety of Y-3 ICO injection versus intravenous injection in the treatment of acute LHI (SOLUTION-2) is a multicentre, prospective, randomised, open-label, blind endpoint trial. 134 patients with acute LHI from more than six centres will be enrolled and randomised in the trial to receive ICO or intravenous injection of Y-3 in a 1:1 ratio.</p><p><strong>Study outcomes: </strong>The primary efficacy outcome is the proportion of patients with a modified Rankin Scale score of 0-3 at 90 days after symptom onset. 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Efficacy and safety of Y-3 intracalvariosseous injection versus intravenous injection in the treatment of acute large hemispheric infarction (SOLUTION-2): rationale and design of a multicentre, prospective, randomised, open-label, blind endpoint (PROBE) trial.
Rationale: The blood-brain barrier (BBB) largely restricts the efficacy of neuroprotectants, which is an important approach in treating large hemispheric infarction (LHI). In this study, we harnessed intracalvariosseous (ICO) injection to bypass the BBB and facilitate drug delivery.
Aim: To compare the efficacy and safety of ICO injection versus intravenous injection in the treatment of acute LHI within 24 hours of disease onset.
Methods and design: The efficacy and safety of Y-3 ICO injection versus intravenous injection in the treatment of acute LHI (SOLUTION-2) is a multicentre, prospective, randomised, open-label, blind endpoint trial. 134 patients with acute LHI from more than six centres will be enrolled and randomised in the trial to receive ICO or intravenous injection of Y-3 in a 1:1 ratio.
Study outcomes: The primary efficacy outcome is the proportion of patients with a modified Rankin Scale score of 0-3 at 90 days after symptom onset. Primary safety outcomes include infection events related to ICO injection procedures.
Discussion: Results from the SOLUTION-2 trial will contribute to the understanding of the efficacy and safety of the Y-3 ICO injection in patients with LHI.
Trial registry: The efficacy and safety of Y-3 ICO injection versus intravenous injection in the treatment of acute LHI (SOLUTION-2). URL: https://clinicaltrials.gov/study/NCT06374667?cond=SOLUTION-2&intr=y-3&rank=1.
期刊介绍：
Journal of Investigative Medicine (JIM) is the official publication of the American Federation for Medical Research. The journal is peer-reviewed and publishes high-quality original articles and reviews in the areas of basic, clinical, and translational medical research.
JIM publishes on all topics and specialty areas that are critical to the conduct of the entire spectrum of biomedical research: from the translation of clinical observations at the bedside, to basic and animal research to clinical research and the implementation of innovative medical care.
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