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献血者特征对输血受者的临床影响:研究献血者 - 受者连续统一体的框架方案

Clinical effects of blood donor characteristics in transfusion recipients: protocol of a framework to study the blood donor-recipient continuum.

作者信息

Chassé Michaël, McIntyre Lauralyn, Tinmouth Alan, Acker Jason, English Shane W, Knoll Greg, Forster Alan, Shehata Nadine, Wilson Kumanan, van Walraven Carl, Ducharme Robin, Fergusson Dean A

机构信息

Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.

Centre for Innovation, Canadian Blood Services, Edmonton, Alberta, Canada.

出版信息

BMJ Open. 2015 Jan 19;5(1):e007412. doi: 10.1136/bmjopen-2014-007412.

Abstract

INTRODUCTION

When used appropriately, transfusion of red blood cells (RBCs) is a necessary life-saving therapy. However, RBC transfusions have been associated with negative outcomes such as infection and organ damage. Seeking explanations for the beneficial and deleterious effects of RBC transfusions is necessary to ensure the safe and optimal use of this precious resource. This study will create a framework to analyse the influence of blood donor characteristics on recipient outcomes.

METHODS AND ANALYSIS

We will conduct a multisite, longitudinal cohort study using blood donor data routinely collected by Canadian Blood Services, and recipient data from health administrative databases. Our project will include a thorough validation of primary data, the linkage of various databases into one large longitudinal database, an in-depth epidemiological analysis and a careful interpretation and dissemination of the results to assist the decision-making process of clinicians, researchers and policymakers in transfusion medicine. Our primary donor characteristic will be age of blood donors and our secondary donor characteristics will be donor-recipient blood group compatibility and blood donor sex. Our primary recipient outcome will be a statistically appropriate survival analysis post-RBC transfusion up to a maximum of 8 years. Our secondary recipient outcomes will include 1-year, 2-year and 5-year mortality; hospital and intensive care unit length of stay; rehospitalisation; new cancer and cancer recurrence rate; infection rate; new occurrence of myocardial infarctions and need for haemodialysis.

ETHICS AND DISSEMINATION

Our results will help determine whether we need to tailor transfusion based on donor characteristics, and perhaps this will improve patient outcome. Our results will be customised to target the different stakeholders involved with blood transfusions and will include presentations, peer-reviewed publications and the use of the dissemination network of blood supply organisations. We obtained approval from the Research Ethics boards and privacy offices of all involved institutions.

摘要

引言

当合理使用时,输注红细胞(RBC)是一种必要的挽救生命的治疗方法。然而,RBC输注与感染和器官损伤等不良后果相关。探寻RBC输注有益和有害作用的解释对于确保安全且最佳地使用这一珍贵资源是必要的。本研究将创建一个框架来分析献血者特征对受血者结局的影响。

方法与分析

我们将开展一项多中心纵向队列研究,使用加拿大血液服务机构常规收集的献血者数据以及来自卫生行政数据库的受血者数据。我们的项目将包括对原始数据的全面验证、将各种数据库链接成一个大型纵向数据库、深入的流行病学分析以及对结果的仔细解读和传播,以协助输血医学领域的临床医生、研究人员和政策制定者进行决策。我们的主要献血者特征将是献血者的年龄,次要献血者特征将是献血者与受血者的血型相容性以及献血者性别。我们的主要受血者结局将是RBC输注后长达8年的统计学上合适的生存分析。我们的次要受血者结局将包括1年、2年和5年死亡率;住院和重症监护病房的住院时长;再次住院;新发癌症和癌症复发率;感染率;新发心肌梗死以及血液透析需求。

伦理与传播

我们的结果将有助于确定是否需要根据献血者特征调整输血,或许这将改善患者结局。我们的结果将针对参与输血的不同利益相关者进行定制,包括报告、同行评审出版物以及利用血液供应组织的传播网络。我们已获得所有相关机构的研究伦理委员会和隐私办公室的批准。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9d64/4305074/508be6699f3d/bmjopen2014007412f01.jpg

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