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评估全球自发性颅内出血患者特征、治疗及短期预后的差异:一项全球观察性前瞻性多中心研究方案(PLOT-ICH研究)

Assessing the global variation in patient characteristics, management and short-term outcomes of spontaneous intracranial haemorrhage worldwide: a protocol for a global observational prospective multicentre study (the PLOT-ICH study).

作者信息

Venturini Sara, Clark David, Smith Brandon George, Hobbs Laura, Bath Michael F, Mee Harry, Still Megan, Mediratta Saniya, Soliman Mohamed Amin, Kohler Katharina, Whiffin Charlotte Jane, Katambo Elijah, Korhonen Tommi K, Tetri Sami, Bankole Nourou Dine Adeniran, Rutabasibwa Nicephorus, Bhebhe Arnold, Munusamy Thangaraj, Tirsit Abenezer, Park Kee B, Budohoski Karol, Wahjoepramono Petra, Tamborska Arina, Saylor Deanna, Khan Tariq, Khattak Almas Fasih, Figaji Anthony, Kolias Angelos G, Bashford Tom, Joannides Alexis, Martin Michael, Trivedi Rikin A, Hutchinson Peter J

机构信息

NIHR Global Health Research Group on Acquired Brain and Spine Injury, University of Cambridge, Cambridge, UK

NIHR Global Health Research Group on Acquired Brain and Spine Injury, University of Cambridge, Cambridge, UK.

出版信息

BMJ Open. 2025 Sep 2;15(9):e100361. doi: 10.1136/bmjopen-2025-100361.

DOI:10.1136/bmjopen-2025-100361
PMID:40897474
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12406811/
Abstract

INTRODUCTION

Stroke is the second leading cause of death worldwide, with the greatest burden in low- and middle-income countries (LMICs). Haemorrhagic stroke or spontaneous intracranial haemorrhage (sICH), including intraparenchymal haemorrhage (IPH) and subarachnoid haemorrhage (SAH), has the highest mortality and morbidity. Local management practices for haemorrhagic stroke vary greatly between geographical regions. The Planetary Outcomes after Intracranial Haemorrhage study aims to provide a global snapshot of the patient characteristics, processes of care and short-term outcomes of patients being treated for sICH across high- and low-income settings. It will also describe variation seen in care processes and available resources and time delays to receiving care. A greater understanding of the current state of sICH care is essential to identify possible interventions and targets for improved standards of care in all settings.

METHODS AND ANALYSIS

We describe a planned prospective, multicentre, international observational cohort study of patients admitted to hospital for management of sICH. We will include patients of all ages presenting to hospital with imaging evidence of sICH (IPH, intraventricular haemorrhage and/or SAH). The study will collect patient, care process and short-term outcome data, following patients for up to 30 days (or until discharge or death, whichever occurs first). Any centre globally where patients with sICH are admitted and managed can participate, targeting a sample size of 712 patients. The study will recruit centres worldwide through pre-existing research networks and by dissemination through neurosurgical and stroke conferences and courses. Each participating centre will complete a site questionnaire alongside patient data collection.

ETHICS AND DISSEMINATION

The study has received ethical approval by the University of Cambridge (PRE.2024.070). Participating centres will also confirm that they have undergone all necessary local governance procedures prior to starting local data collection. The findings will be disseminated via open access peer-reviewed journals, relevant conferences and other professional networks and lay channels, including the study website (https://plotich.org/) and social media channels (@plotichstudy).

TRIALS REGISTRATION NUMBER

NCT06731751.

摘要

引言

中风是全球第二大死因,在低收入和中等收入国家(LMICs)负担最重。出血性中风或自发性颅内出血(sICH),包括脑实质内出血(IPH)和蛛网膜下腔出血(SAH),死亡率和发病率最高。出血性中风的局部管理做法在不同地理区域差异很大。颅内出血后行星结局研究旨在提供全球范围内高收入和低收入环境下接受sICH治疗患者的特征、护理过程和短期结局的概况。它还将描述护理过程、可用资源以及接受护理的时间延迟方面存在的差异。更深入了解sICH护理的现状对于确定所有环境下改善护理标准的可能干预措施和目标至关重要。

方法与分析

我们描述了一项针对因sICH入院治疗的患者的前瞻性、多中心、国际观察性队列研究计划。我们将纳入所有年龄因sICH(IPH、脑室内出血和/或SAH)影像学证据入院的患者。该研究将收集患者、护理过程和短期结局数据,对患者随访长达30天(或直至出院或死亡,以先发生者为准)。全球任何收治和管理sICH患者的中心均可参与,目标样本量为712名患者。该研究将通过现有的研究网络,并通过神经外科和中风会议及课程进行传播,在全球招募中心。每个参与中心将在收集患者数据的同时完成一份站点问卷。

伦理与传播

该研究已获得剑桥大学的伦理批准(PRE.2024.070)。参与中心还将确认在开始本地数据收集之前已完成所有必要的本地管理程序。研究结果将通过开放获取的同行评审期刊以及相关会议、其他专业网络和大众渠道进行传播,包括研究网站(https://plotich.org/)和社交媒体渠道(@plotichstudy)。

试验注册号

NCT06731751

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