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蛛网膜下腔出血国际试验者(SAHIT)资料库:推动蛛网膜下腔出血的临床研究

The Subarachnoid Hemorrhage International Trialists (SAHIT) Repository: advancing clinical research in subarachnoid hemorrhage.

作者信息

Jaja Blessing N R, Attalla Daniel, Macdonald R Loch, Schweizer Tom A, Cusimano Michael D, Etminan Nima, Hanggi Daniel, Hasan David, Johnston S Claiborne, Le Roux Peter, Lo Benjamin, Louffat-Olivares Ada, Mayer Stephan, Molyneux Andrew, Noble Adam, Quinn Audrey, Schenk Thomas, Spears Julian, Singh Jeffrey, Todd Michael, Torner James, Tseng Ming, van den Bergh William, Vergouwen Mervyn D I, Wong George K C

机构信息

Division of Neurosurgery, Department of Surgery, St. Michael's Hospital, Labatt Family Centre of Excellence in Brain Injury and Trauma Research, Keenan Research Centre of the Li Ka Shing Knowledge Institute of St. Michael's Hospital, University of Toronto, 30 Bond Street, Toronto, ON, M5B 1W8, Canada.

出版信息

Neurocrit Care. 2014 Dec;21(3):551-9. doi: 10.1007/s12028-014-9990-y.

DOI:10.1007/s12028-014-9990-y
PMID:24865271
Abstract

Researchers and other stakeholders continue to express concern about the failure of randomized clinical trials (RCT) in subarachnoid hemorrhage (SAH) to show efficacy of new treatments. Pooled data may be particularly useful to generate hypotheses about causes of poor outcomes and reasons for failure of RCT in SAH, and strategies to improve them. Investigators conducting SAH research collaborated to share data with the intent to develop a large repository of pooled individual patient data for exploratory analysis and testing of new hypotheses relevant to improved trial design and analysis in SAH. This repository currently contains information on 11,443 SAH patients from 14 clinical databases, of which 9 are datasets of recent RCTs and 5 are datasets of prospective observational studies and hospital registries. Most patients were managed in the last 15 years. Data validation and quality checks have been conducted and are satisfactory. Data is available on demographic, clinical, neuroimaging, and laboratory results and various outcome measures. We have compiled the largest known dataset of patients with SAH. The SAHIT repository may be an important resource for advancing clinical research in SAH and will benefit from contributions of additional datasets.

摘要

研究人员和其他利益相关者继续对蛛网膜下腔出血(SAH)的随机临床试验(RCT)未能显示新治疗方法的疗效表示担忧。汇总数据对于生成关于不良结局原因、SAH中RCT失败原因以及改善这些情况的策略的假设可能特别有用。开展SAH研究的调查人员进行了合作,以共享数据,目的是建立一个大型汇总个体患者数据库,用于探索性分析以及检验与改进SAH试验设计和分析相关的新假设。该数据库目前包含来自14个临床数据库的11443例SAH患者的信息,其中9个是近期RCT的数据集,5个是前瞻性观察性研究和医院登记处的数据集。大多数患者是在过去15年中接受治疗的。已经进行了数据验证和质量检查,结果令人满意。可获取有关人口统计学、临床、神经影像学、实验室结果以及各种结局指标的数据。我们汇编了已知的最大的SAH患者数据集。SAHIT数据库可能是推进SAH临床研究的重要资源,并且将受益于更多数据集的贡献。

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Transl Stroke Res. 2013 Jun;4(3):286-96. doi: 10.1007/s12975-012-0242-1. Epub 2013 Jan 7.
2
Prospective, randomized, open-label phase II trial on concomitant intraventricular fibrinolysis and low-frequency rotation after severe subarachnoid hemorrhage.前瞻性、随机、开放标签的 II 期临床试验:在严重蛛网膜下腔出血后同时进行脑室内纤维蛋白溶解和低频旋转。
Stroke. 2013 Aug;44(8):2162-8. doi: 10.1161/STROKEAHA.113.001790. Epub 2013 Jun 4.
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Cause-specific mortality of 1-year survivors of subarachnoid hemorrhage.
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Front Neurol. 2022 Mar 14;13:846066. doi: 10.3389/fneur.2022.846066. eCollection 2022.
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Pathophysiology of Delayed Cerebral Ischemia After Subarachnoid Hemorrhage: A Review.颅内出血后迟发性脑缺血的病理生理学:综述。
J Am Heart Assoc. 2021 Aug 3;10(15):e021845. doi: 10.1161/JAHA.121.021845. Epub 2021 Jul 30.
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What You Need to Know Before Implementing a Clinical Research Data Warehouse: Comparative Review of Integrated Data Repositories in Health Care Institutions.实施临床研究数据仓库之前你需要了解的内容:医疗机构综合数据存储库的比较综述
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