Alberto Fogagnolo, Danila Azzolina, Fabio Silvio Taccone, Emma Pedarzani, Gianluca Pasa, Daniele Marianello, Giorgia Valpiani, Chiara Marchesini, Filippo Annoni, Anthony Moureau, Carlo Alberto Volta, Federico Franchi, Savino Spadaro
{"title":"重症患者以抽氧为指导的输血策略：随机、开放标签对照试验的研究方案。","authors":"Alberto Fogagnolo, Danila Azzolina, Fabio Silvio Taccone, Emma Pedarzani, Gianluca Pasa, Daniele Marianello, Giorgia Valpiani, Chiara Marchesini, Filippo Annoni, Anthony Moureau, Carlo Alberto Volta, Federico Franchi, Savino Spadaro","doi":"10.1136/bmjopen-2024-089910","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>In critically ill patients, individualised strategies for red blood cell transfusion (RBCT) are lacking. The objective of this study is to demonstrate the potential advantages of employing an individualised transfusion strategy compared with a restrictive approach, in unselected intensive care unit (ICU) patients.</p><p><strong>Methods: </strong>This will be a randomised, multicentre, international trial. Two open-label parallel groups will be compared with an allocation ratio of 1:1. The trial is designed to investigate the superiority of the individualised intervention group compared with the standard intervention group. The study will be performed in three mixed, academic ICUs located in two different countries. In the individualised group, prescription of RCBT is restricted to patients who present haemoglobin (Hb) ≤9.0 g/dL and oxygen extraction ratio (O<sub>2</sub>ER) ≥ 30%, for a minimum Hb value of ≤6.0 g/dL. In the control group, prescription of RBCT is guided by thresholds proposed by recent guidelines, regardless of O<sub>2</sub>ER values.</p><p><strong>Ethics and dissemination: </strong>This trial is approved by the Comitato Etico Area Vasta Centro della Regione Emilia-Romagna (protocol number 350/2023/Sper/AOUFe/PRBCT, date of approval 18/05/2023) and ethic boards at all participating sites. Our results will be published and shared with relevant organisations and healthcare professionals.</p><p><strong>Trial registration number: </strong>Clinicaltrials.gov NCT06102590.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":null,"pages":null},"PeriodicalIF":2.4000,"publicationDate":"2024-11-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Oxygen extraction-guided transfusion strategy in critically ill patients: study protocol for a randomised, open-labelled, controlled trial.\",\"authors\":\"Alberto Fogagnolo, Danila Azzolina, Fabio Silvio Taccone, Emma Pedarzani, Gianluca Pasa, Daniele Marianello, Giorgia Valpiani, Chiara Marchesini, Filippo Annoni, Anthony Moureau, Carlo Alberto Volta, Federico Franchi, Savino Spadaro\",\"doi\":\"10.1136/bmjopen-2024-089910\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Introduction: </strong>In critically ill patients, individualised strategies for red blood cell transfusion (RBCT) are lacking. The objective of this study is to demonstrate the potential advantages of employing an individualised transfusion strategy compared with a restrictive approach, in unselected intensive care unit (ICU) patients.</p><p><strong>Methods: </strong>This will be a randomised, multicentre, international trial. Two open-label parallel groups will be compared with an allocation ratio of 1:1. The trial is designed to investigate the superiority of the individualised intervention group compared with the standard intervention group. The study will be performed in three mixed, academic ICUs located in two different countries. In the individualised group, prescription of RCBT is restricted to patients who present haemoglobin (Hb) ≤9.0 g/dL and oxygen extraction ratio (O<sub>2</sub>ER) ≥ 30%, for a minimum Hb value of ≤6.0 g/dL. In the control group, prescription of RBCT is guided by thresholds proposed by recent guidelines, regardless of O<sub>2</sub>ER values.</p><p><strong>Ethics and dissemination: </strong>This trial is approved by the Comitato Etico Area Vasta Centro della Regione Emilia-Romagna (protocol number 350/2023/Sper/AOUFe/PRBCT, date of approval 18/05/2023) and ethic boards at all participating sites. Our results will be published and shared with relevant organisations and healthcare professionals.</p><p><strong>Trial registration number: </strong>Clinicaltrials.gov NCT06102590.</p>\",\"PeriodicalId\":9158,\"journal\":{\"name\":\"BMJ Open\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":2.4000,\"publicationDate\":\"2024-11-12\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"BMJ Open\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1136/bmjopen-2024-089910\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"MEDICINE, GENERAL & INTERNAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"BMJ Open","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1136/bmjopen-2024-089910","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"MEDICINE, GENERAL & INTERNAL","Score":null,"Total":0}
引用次数: 0
摘要
导言：在重症患者中，缺乏个性化的红细胞输注（RBCT）策略。本研究的目的是在未经选择的重症监护病房（ICU）患者中，证明采用个体化输血策略与限制性输血策略相比的潜在优势：方法：这将是一项随机、多中心的国际试验。方法：这将是一项随机、多中心、国际性试验，将对两个开放标签平行组进行比较，分配比例为 1:1。试验旨在研究个性化干预组与标准干预组相比的优越性。研究将在两个不同国家的三家混合型学术重症监护病房进行。在个体化干预组中，RCBT 的处方仅限于血红蛋白（Hb）≤9.0 g/dL 和氧萃取率（O2ER）≥30% 的患者，最低 Hb 值为≤6.0 g/dL。在对照组中，RBCT 的处方以近期指南提出的阈值为指导，与 O2ER 值无关：本试验已获得艾米利亚-罗马涅大区Comitato Etico Area Vasta Centro（协议编号350/2023/Sper/AOUFe/PRBCT，批准日期2023年5月18日）和所有参与研究机构的伦理委员会的批准。我们的研究结果将公布于众，并与相关机构和医护人员分享：试验注册号：Clinicaltrials.gov NCT06102590。
Oxygen extraction-guided transfusion strategy in critically ill patients: study protocol for a randomised, open-labelled, controlled trial.
Introduction: In critically ill patients, individualised strategies for red blood cell transfusion (RBCT) are lacking. The objective of this study is to demonstrate the potential advantages of employing an individualised transfusion strategy compared with a restrictive approach, in unselected intensive care unit (ICU) patients.
Methods: This will be a randomised, multicentre, international trial. Two open-label parallel groups will be compared with an allocation ratio of 1:1. The trial is designed to investigate the superiority of the individualised intervention group compared with the standard intervention group. The study will be performed in three mixed, academic ICUs located in two different countries. In the individualised group, prescription of RCBT is restricted to patients who present haemoglobin (Hb) ≤9.0 g/dL and oxygen extraction ratio (O2ER) ≥ 30%, for a minimum Hb value of ≤6.0 g/dL. In the control group, prescription of RBCT is guided by thresholds proposed by recent guidelines, regardless of O2ER values.
Ethics and dissemination: This trial is approved by the Comitato Etico Area Vasta Centro della Regione Emilia-Romagna (protocol number 350/2023/Sper/AOUFe/PRBCT, date of approval 18/05/2023) and ethic boards at all participating sites. Our results will be published and shared with relevant organisations and healthcare professionals.
期刊介绍：
BMJ Open is an online, open access journal, dedicated to publishing medical research from all disciplines and therapeutic areas. The journal publishes all research study types, from study protocols to phase I trials to meta-analyses, including small or specialist studies. Publishing procedures are built around fully open peer review and continuous publication, publishing research online as soon as the article is ready.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
