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动脉瘤性蛛网膜下腔出血患者远程缺血预处理疗效研究(REPAIR):一项多中心、随机、双盲、假手术对照、平行组试验方案

Remote ischaemic conditioning for efficacy in patients with aneurysmal subarachnoid haemorrhage (REPAIR): protocol for a multicentre, randomised, double-blind, sham-controlled, parallel-group trial.

作者信息

Jin Tonghu, Niu Hao, Liu Lan, Yin Yunjian, Zhao Wenbo, Feng Xin, Xu Liuyu, Hess David C, Liu Aihua, Ji Xunming

机构信息

Beijing Neurosurgical Institute, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.

Beijing Institute For Brain Disorders, Beijing, China.

出版信息

BMJ Open. 2025 Aug 11;15(8):e101350. doi: 10.1136/bmjopen-2025-101350.

DOI:10.1136/bmjopen-2025-101350
PMID:40789732
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12352245/
Abstract

INTRODUCTION

A large number of basic and clinical studies have demonstrated that remote ischaemic conditioning (RIC) has neuroprotective effects. Recently, RIC has made gratifying progress in the field of ischaemia stroke treatment. A considerable number of basic and clinical studies have also revealed the possible therapeutic effects of RIC on subarachnoid haemorrhage. However, the neuroprotective effect of RIC on subarachnoid haemorrhage is still lacking convincing evidence and deserves further study.

AIM

To explore the efficacy and safety of RIC for aneurysmal subarachnoid haemorrhage.

METHODS AND ANALYSIS

An investigator-initiated, multicentre, randomised, double-blind, sham-controlled, parallel-group trial to evaluate the effect of RIC intervention compared to sham RIC intervention for the neurological function improvement of patients with aneurysmal subarachnoid haemorrhage.

ETHICS AND DISSEMINATION

The protocol was approved by the IRB of Beijing Tiantan Hospital, Capital Medical University (KY2024-080-03). Progress and safety of the trial are monitored by an independent Data and Safety Monitoring Board. Study results will be published in peer-reviewed medical journals. Written informed consent will be obtained from all participants.

TRIAL REGISTRATION NUMBER

NCT06711302.

摘要

引言

大量基础和临床研究表明,远程缺血预处理(RIC)具有神经保护作用。近年来,RIC在缺血性脑卒中治疗领域取得了令人满意的进展。相当数量的基础和临床研究也揭示了RIC对蛛网膜下腔出血可能具有的治疗作用。然而,RIC对蛛网膜下腔出血的神经保护作用仍缺乏令人信服的证据,值得进一步研究。

目的

探讨RIC治疗动脉瘤性蛛网膜下腔出血的有效性和安全性。

方法与分析

一项由研究者发起的、多中心、随机、双盲、假对照、平行组试验,旨在评估RIC干预与假RIC干预相比,对动脉瘤性蛛网膜下腔出血患者神经功能改善的效果。

伦理与传播

该方案已获得首都医科大学附属北京天坛医院伦理审查委员会批准(KY2024-080-03)。试验的进展和安全性由独立的数据与安全监测委员会进行监测。研究结果将发表在同行评审的医学期刊上。将获得所有参与者的书面知情同意书。

试验注册号

NCT06711302。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ee3f/12352245/ddb1b8ff145a/bmjopen-15-8-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ee3f/12352245/ddb1b8ff145a/bmjopen-15-8-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ee3f/12352245/ddb1b8ff145a/bmjopen-15-8-g001.jpg

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本文引用的文献

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Remote ischemic conditioning for stroke: A critical systematic review.远程缺血预处理治疗脑卒中:一项关键性系统评价。
Int J Stroke. 2024 Mar;19(3):271-279. doi: 10.1177/17474930231191082. Epub 2023 Aug 1.
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Effectiveness of Lumbar Cerebrospinal Fluid Drain Among Patients With Aneurysmal Subarachnoid Hemorrhage: A Randomized Clinical Trial.腰椎脑脊液引流在动脉瘤性蛛网膜下腔出血患者中的疗效:一项随机临床试验。
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A correlation and prediction study of the poor prognosis of high-grade aneurysmal subarachnoid hemorrhage from the neutrophil percentage to albumin ratio.
中性粒细胞百分比与白蛋白比值与高级别动脉瘤性蛛网膜下腔出血不良预后的相关性及预测研究。
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A Pooled Analysis of Preoperative Inflammatory Biomarkers to Predict 90-Day Outcomes in Patients with an Aneurysmal Subarachnoid Hemorrhage: A Single-Center Retrospective Study.术前炎症生物标志物预测动脉瘤性蛛网膜下腔出血患者90天预后的汇总分析:一项单中心回顾性研究
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Chronic remote ischaemic conditioning in patients with symptomatic intracranial atherosclerotic stenosis (the RICA trial): a multicentre, randomised, double-blind sham-controlled trial in China.症状性颅内动脉粥样硬化狭窄患者的慢性远程缺血预处理(RICA 试验):中国多中心、随机、双盲假手术对照试验。
Lancet Neurol. 2022 Dec;21(12):1089-1098. doi: 10.1016/S1474-4422(22)00335-0. Epub 2022 Oct 27.
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Effect of Remote Ischemic Conditioning vs Usual Care on Neurologic Function in Patients With Acute Moderate Ischemic Stroke: The RICAMIS Randomized Clinical Trial.远程缺血预处理与常规治疗对急性中度缺血性脑卒中患者神经功能的影响:RICAMIS 随机临床试验。
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The effect of sex differences on complications and 90-day outcomes after aneurysmal subarachnoid hemorrhage: a propensity score-matched analysis.性别差异对动脉瘤性蛛网膜下腔出血后并发症和 90 天结局的影响:倾向评分匹配分析。
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Comparing Protection of Remote Limb with Resveratrol Preconditioning following Rodent Subarachnoid Hemorrhage.比较雷帕霉素预处理对鼠蛛网膜下腔出血后远隔肢体保护作用。
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Immune Modulation as a Key Mechanism for the Protective Effects of Remote Ischemic Conditioning After Stroke.免疫调节作为中风后远程缺血预处理保护作用的关键机制。
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