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术后加强护理病房输血后受血者生存与献血者年龄的关联:一项多中心随机对照试验研究方案。

Association between recipient survival and blood donor age after blood transfusion in a surgery intensive care unit: a multicenter randomized controlled trial study protocol.

机构信息

School of Medicine, Northwest University, Xi'an, 710069, China.

The National Engineering Research Center for Miniaturized Detection Systems, College of Life Science, Northwest University, Xi'an, 710069, China.

出版信息

Trials. 2020 Jul 8;21(1):621. doi: 10.1186/s13063-020-04452-6.

Abstract

BACKGROUND

Blood from younger individuals has been shown to improve physiological function in recipients in laboratory research, and many proteins from human peripheral blood show antisenescence capabilities. Thus, researchers have questioned whether blood from young donors is superior to blood from older donors. Blood transfusion is a key supportive therapy for trauma patients, and recent studies have reported the influence of blood donor age on recipient patient prognosis. Although some retrospective results found that blood from young donors improves survival, no influence of blood donor age was observed on outcomes in other study groups. The reasons for this discrepancy are complicated, but the fact that data were not obtained from randomized controlled trial (RCT) data should be considered. The current protocol and analysis method provide a feasible RCT design to evaluate the prognosis of severely ill surgery patients who were transfused with blood products from blood donors of different ages.

METHODS

The current study is a pragmatic multicenter RCT (open, parallel-group, non-masked, superiority trial). Recruited surgery intensive care unit patients will be randomized into three groups and transfused with blood products from male donors of different ages (< 25, 25-45, and > 45 years). Survival time will be measured within 28 days. The survival characteristics, possible interaction between variables, and potential factors associated with death will be analyzed by Kaplan-Meier analysis, two-way ANOVA, and Cox proportional hazards model, respectively.

TRIAL REGISTRATION

ChiCTR: ChiCTR190002. Registered on 22 March 2019. http://www.chictr.org.cn/showproj.aspx?proj=36867 .

摘要

背景

实验室研究表明,年轻个体的血液可以改善接受者的生理功能,并且人体外周血液中的许多蛋白质都具有抗衰老能力。因此,研究人员质疑年轻供体的血液是否优于老年供体的血液。输血是创伤患者的关键支持性治疗方法,最近的研究报告了供体年龄对接受者患者预后的影响。尽管一些回顾性研究结果发现年轻供体的血液可以提高生存率,但在其他研究组中没有观察到供体年龄对结果的影响。造成这种差异的原因很复杂,但应该考虑到数据并非来自随机对照试验 (RCT) 数据。目前的方案和分析方法提供了一种可行的 RCT 设计,可用于评估输注来自不同年龄供体血液制品的重病手术患者的预后。

方法

本研究为一项实用的多中心 RCT(开放性、平行组、非盲法、优效性试验)。招募的手术重症监护病房患者将随机分为三组,并输注来自不同年龄(<25、25-45 和>45 岁)男性供体的血液制品。在 28 天内测量生存时间。通过 Kaplan-Meier 分析、双向 ANOVA 和 Cox 比例风险模型分别分析生存特征、变量之间可能的相互作用以及与死亡相关的潜在因素。

试验注册

ChiCTR:ChiCTR190002. 注册于 2019 年 3 月 22 日。http://www.chictr.org.cn/showproj.aspx?proj=36867。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a796/7341644/4c4fdc5dc0ee/13063_2020_4452_Fig1_HTML.jpg

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