Introduction Multicentre preclinical randomised controlled trials (pRCT) are emerging as a necessary step to confirm efficacy and improve translation into the clinic. The aim of this project is to perform two multicentre pRCTs (one in rats and one in mice) to investigate the efficacy of remote ischaemic conditioning (RIC) in an experimental model of severe ischaemic stroke. Methods and analysis Seven research laboratories within the Italian Stroke Organization (ISO) Basic Science network will participate in the study. Transient endovascular occlusion of the proximal right middle cerebral artery will be performed in two species (rats and mice) and in both sexes. Animals will be randomised to receive RIC by transient surgical occlusion of the right femoral artery, or sham surgery, after reperfusion. Blinded outcome assessment will be performed for dichotomised functional neuroscore (primary endpoint) and infarct volume (secondary endpoint) at 48 hours. A sample size of 80 animals per species will yield 82% power to detect a significant difference of 30% in the primary outcome in both pRCTs. Analyses will be performed in a blind status and according to an intention-to-treat paradigm. The results of this study will provide robust, translationally oriented, high-quality evidence on the efficacy of RIC in multiple species of rodents with large ischaemic stroke. Ethics and dissemination This is approved by the Animal Welfare Regulatory Body of the University of Milano Bicocca, under project license from the Italian Ministry of Health. Trial results will be subject to publication according to the definition of the outcome presented in this protocol. Trial registration number PCTE0000177.

中文翻译：

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急性缺血性卒中远程缺血调节的多中心转化试验 (TRICS)：来自意大利卒中组织 (ISO) 基础科学网络的雌性和雄性大鼠和小鼠的多中心、平行组、随机、临床前试验方案

简介 多中心临床前随机对照试验 (pRCT) 正在成为确认疗效和改进临床转化的必要步骤。该项目的目的是进行两项多中心 pRCT（一项在大鼠中，一项在小鼠中），以研究远程缺血调理 (RIC) 在严重缺血性中风实验模型中的功效。方法和分析 意大利中风组织 (ISO) 基础科学网络内的七个研究实验室将参与这项研究。将在两种物种（大鼠和小鼠）和两种性别中进行右大脑中动脉近端的短暂血管内闭塞。再灌注后，通过右股动脉的短暂手术闭塞或假手术将动物随机化接受RIC。将在 48 小时对二分功能神经评分（主要终点）和梗塞体积（次要终点）进行盲法结果评估。每个物种 80 只动物的样本量将产生 82% 的功效来检测两个 pRCT 的主要结果中 30% 的显着差异。分析将在盲态下根据意向治疗范式进行。本研究的结果将为 RIC 在多种大面积缺血性卒中啮齿动物中的疗效提供强有力的、以转化为导向的、高质量的证据。伦理和传播 这是由米兰比可卡大学动物福利监管机构批准的，获得意大利卫生部的项目许可。试验结果将根据本协议中提出的结果定义发布。试用注册号 PCTE0000177。