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一项关于心脏手术后输血指征阈值降低对输血率、发病率和医疗资源使用影响的多中心随机对照试验:研究方案。

A multi-centre randomised controlled trial of Transfusion Indication Threshold Reduction on transfusion rates, morbidity and healthcare resource use following cardiac surgery: study protocol.

作者信息

Brierley Rachel C M, Pike Katie, Miles Alice, Wordsworth Sarah, Stokes Elizabeth A, Mumford Andrew D, Cohen Alan, Angelini Gianni D, Murphy Gavin J, Rogers Chris A, Reeves Barnaby C

机构信息

Clinical Trials and Evaluation Unit, School of Clinical Sciences, University of Bristol, Bristol Royal Infirmary, Bristol BS2 8HW, UK.

Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Old Road Campus, Old Road, Headington, Oxford OX3 7LF, UK.

出版信息

Transfus Apher Sci. 2014 Jun;50(3):451-61. doi: 10.1016/j.transci.2014.02.020. Epub 2014 Mar 12.

DOI:10.1016/j.transci.2014.02.020
PMID:24675014
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4064699/
Abstract

Thresholds for red blood cell transfusion following cardiac surgery vary by hospital and surgeon. The TITRe2 multi-centre randomised controlled trial aims to randomise 2000 patients from 17 United Kingdom centres, and tests the hypothesis that a restrictive transfusion threshold will reduce postoperative morbidity and health service costs compared to a liberal threshold. Patients consent to take part in the study pre-operatively but are only randomised if their haemoglobin falls below 9 g/dL during their post-operative hospital stay. The primary outcome is a binary composite outcome of any serious infectious or ischaemic event in the first three months after randomisation. Many challenges have been encountered in the set-up and running of the study.

摘要

心脏手术后红细胞输血的阈值因医院和外科医生而异。TITRe2多中心随机对照试验旨在将来自英国17个中心的2000名患者随机分组,并检验以下假设:与宽松阈值相比,限制性输血阈值将降低术后发病率和医疗服务成本。患者在术前同意参与研究,但只有在术后住院期间血红蛋白降至9 g/dL以下时才会被随机分组。主要结局是随机分组后前三个月内任何严重感染或缺血事件的二元复合结局。在研究的设置和开展过程中遇到了许多挑战。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a0a7/4064699/1af4acdaf0da/gr3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a0a7/4064699/f45f25ee4e01/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a0a7/4064699/92c362f98444/gr2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a0a7/4064699/1af4acdaf0da/gr3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a0a7/4064699/f45f25ee4e01/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a0a7/4064699/92c362f98444/gr2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a0a7/4064699/1af4acdaf0da/gr3.jpg

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本文引用的文献

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Trials. 2015 Feb 22;16:54. doi: 10.1186/s13063-015-0564-x.
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N Engl J Med. 2011 Dec 29;365(26):2453-62. doi: 10.1056/NEJMoa1012452. Epub 2011 Dec 14.
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Identification of risk factors by systematic review and development of risk-adjusted models for surgical site infection.
心脏手术后较低水平的红细胞输注是否比宽松水平更具成本效益?TITRe2随机对照试验的结果。
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4
Adherence to transfusion strategies in a randomized controlled trial: experiences from the TITRe2 trial.一项随机对照试验中输血策略的依从性:TITRe2试验的经验
Br J Haematol. 2017 Oct;179(2):346-349. doi: 10.1111/bjh.14220. Epub 2016 Jul 5.
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An evidence-based approach to red blood cell transfusions in asymptomatically anaemic patients.无症状贫血患者红细胞输注的循证方法
Ann R Coll Surg Engl. 2015 Nov;97(8):556-62. doi: 10.1308/rcsann.2015.0047.
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