West China Liu's Score for Individualized Red Cells Transfusion Strategy in Non-Cardiac Surgery: Study Protocol for a Multicenter, Randomized, Controlled Trial

L. Ren, Sun Hao-Rui, Liu Jin
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引用次数: 1

Abstract

Background: Transfusion trigger and target for surgical patients with hemoglobin level between 6-10 grams per deciliter (gram per deciliter) is not implemented worldwide. The decision of whether red cells should be given to these patients is often made according to the experience of clinicians without specific clinical or laboratory evidence. Based on the physiology of the balance between oxygen supply and consumption, we developed the West China Liu's Score that will help clinicians to make individualized transfusion decisions for patients undergoing elective non-cardiac major surgery. The aim of this study is to determine whether the individualized red cells transfusion strategy, when compared with restrictive transfusion strategy (red cells transfusion trigger based on the judgment of physicians according to current transfusion guidelines) and liberal transfusion strategy (red cells transfusion trigger of 10 grams per deciliter), will decrease red cells transfusion requirement without increasing mortality or postoperative complications, or delaying incision healing, or increasing the cost of hospitalization.Methods and Design: This trial is a prospective, multicenter, randomized controlled trial that will test the superiority of the individualized transfusion strategy to restrictive transfusion strategy and liberal transfusion strategy in terms of reducing red cells transfusion demands safely and effectively. A total of 4200 patients undergoing elective major surgery with estimated intra-operative blood loss more than 1000 ml or 20% of total blood volume and perioperative hemoglobin less than 10 grams per deciliter will be randomized into individualized-strategy group, restrictive-strategy group, and liberal-strategy group. The primary outcomes of the study are the incidences of red cells transfusion and combination of in-hospital death for any reason and serious complications.Discussion: The individualized transfusion strategy guided by application of West China Liu's score will provide a new insight on the perioperative transfusion practice and new clinical proof for the transfusion guidelines.Trial Registration: This trial was registered at ClinicalTrials.gov (identifier NCT01597232) on 14 May 2012. Citation: Ren Liao, Hao-Rui Sun, Jin Liu. West China Liu's Score for individualized red cells transfusion strategy in non-cardiac surgery: study protocol for a multicenter, randomized, controlled trial. J Anesth Perioper Med 2016; 3: 225-32. doi: 10.24015/JAPM.2016.0030This is an open-access article, published by Evidence Based Communications (EBC). This work is licensed under the Creative Commons Attribution 4.0 International License, which permits unrestricted use, distribution, and reproduction in any medium or format for any lawful purpose. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/.
非心脏手术个体化红细胞输注策略的评分:一项多中心、随机、对照试验的研究方案
背景:血红蛋白水平在6-10克/分升(克/分升)之间的外科患者的输血触发点和靶标在世界范围内尚未实施。是否应该给予这些患者红细胞的决定往往是根据临床医生的经验,没有具体的临床或实验室证据。基于供氧和耗氧平衡的生理学,我们开发了中国西部刘氏评分,它将帮助临床医生为选择性非心脏大手术患者做出个性化的输血决策。本研究的目的是确定与限制性输血策略(根据医生根据现行输血指南判断的红细胞输血触发)和自由输血策略(每分升10克红细胞输血触发)相比,个体化红细胞输血策略是否会减少红细胞输血需求,而不会增加死亡率或术后并发症,或延迟切口愈合。或者增加住院费用。方法和设计:本试验是一项前瞻性、多中心、随机对照试验,旨在检验个体化输血策略相对于限制性输血策略和自由输血策略在安全有效地减少红细胞输血需求方面的优势。共有4200例接受择期大手术的患者,术中估计失血量超过1000 ml或总血容量的20%,围手术期血红蛋白低于10克/分升,随机分为个体化策略组、限制性策略组和自由策略组。该研究的主要结局是红细胞输注的发生率、院内任何原因死亡和严重并发症的发生率。讨论:应用华西刘氏评分指导的个体化输血策略将为围手术期输血实践提供新的见解,为输血指南提供新的临床依据。试验注册:该试验于2012年5月14日在ClinicalTrials.gov(标识符NCT01597232)注册。引用本文:廖仁,孙浩睿,刘瑾。非心脏手术个体化红细胞输血策略的评分:一项多中心、随机、对照试验的研究方案。中华外科杂志2016;3: 225 - 32。doi: 10.24015/ japm .2016.0030这是一篇开放获取的文章,由Evidence Based Communications (EBC)发表。本作品遵循知识共享署名4.0国际许可协议,允许以任何媒介或格式出于任何合法目的不受限制地使用、分发和复制。要查看此许可证的副本,请访问http://creativecommons.org/licenses/by/4.0/。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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