Liberal transfusion strategy to prevent mortality and anaemia-associated, ischaemic events in elderly non-cardiac surgical patients – the study design of the LIBERAL-Trial

  • Background: Perioperative anaemia leads to impaired oxygen supply with a risk of vital organ ischaemia. In healthy and fit individuals, anaemia can be compensated by several mechanisms. Elderly patients, however, have less compensatory mechanisms because of multiple co-morbidities and age-related decline of functional reserves. The purpose of the study is to evaluate whether elderly surgical patients may benefit from a liberal red blood cell (RBC) transfusion strategy compared to a restrictive transfusion strategy. Methods: The LIBERAL Trial is a prospective, randomized, multicentre, controlled clinical phase IV trial randomising 2470 elderly (≥ 70 years) patients undergoing intermediate- or high-risk non-cardiac surgery. Registered patients will be randomised only if Haemoglobin (Hb) reaches ≤9 g/dl during surgery or within 3 days after surgery either to the LIBERAL group (transfusion of a single RBC unit when Hb ≤ 9 g/dl with a target range for the post-transfusion Hb level of 9–10.5 g/dl) or the RESTRICTIVE group (transfusion of a single RBC unit when Hb ≤ 7.5 g/dl with a target range for the post-transfusion Hb level of 7.5–9 g/dl). The intervention per patient will be followed until hospital discharge or up to 30 days after surgery, whichever occurs first. The primary efficacy outcome is defined as a composite of all-cause mortality, acute myocardial infarction, acute ischaemic stroke, acute kidney injury (stage III), acute mesenteric ischaemia and acute peripheral vascular ischaemia within 90 days after surgery. Infections requiring iv antibiotics with re-hospitalisation are assessed as important secondary endpoint. The primary endpoint will be analysed by logistic regression adjusting for age, cancer surgery (y/n), type of surgery (intermediate- or high-risk), and incorporating centres as random effect. Discussion: The LIBERAL-Trial will evaluate whether a liberal transfusion strategy reduces the occurrence of major adverse events after non-cardiac surgery in the geriatric population compared to a restrictive strategy within 90 days after surgery. Trial registration: ClinicalTrials.gov (identifier: NCT03369210).

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Author:Patrick MeybohmORCiDGND, Simone Lindau, Sascha Treskatsch, Roland Francis, Claudia Spies, Markus Velten, Maria Wittmann, Erdem Özer GüresirORCiDGND, Christian StoppeORCiDGND, Ana Kowark, Mark Coburn, Sixten Selleng, Marcel Baschin, Gregor Jenichen, Melanie Meersch, Thomas Ermert, Alexander Zarbock, Peter Kranke, Markus Kredel, Antonia Helf, Rita Laufenberg-Feldmann, Marion Ferner, Eva Wittenmeier, Karl-Heinz Gürtler, Peter Kienbaum, Marcelo Gama de Abreu, Michael Sander, Michael BauerORCiDGND, Timo Seyfried, Matthias Lars Grünewald, Suma Choorapoikayil, Markus M. Müller, Erhard SeifriedORCiDGND, Oana Brosteanu, Holger Bogatsch, Dirk Hasenclever, Kai ZacharowskiORCiDGND
URN:urn:nbn:de:hebis:30:3-490751
DOI:https://doi.org/10.1186/s13063-019-3200-3
ISSN:1468-6694
ISSN:1745-6215
ISSN:1468-6708
Pubmed Id:https://pubmed.ncbi.nlm.nih.gov/30717805
Parent Title (English):Trials
Publisher:BioMed Central
Place of publication:London
Document Type:Article
Language:English
Year of Completion:2019
Date of first Publication:2019/02/04
Publishing Institution:Universitätsbibliothek Johann Christian Senckenberg
Contributing Corporation:LIBERAL Collaboration Group
Release Date:2019/02/19
Tag:Red blood cell transfusion; anaemia; elderly patients; surgery
Volume:20
Issue:1, Art. 101
Page Number:10
First Page:1
Last Page:10
Note:
Open Access: This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
HeBIS-PPN:44647312X
Institutes:Medizin / Medizin
Dewey Decimal Classification:6 Technik, Medizin, angewandte Wissenschaften / 61 Medizin und Gesundheit / 610 Medizin und Gesundheit
Sammlungen:Universitätspublikationen
Licence (German):License LogoCreative Commons - Namensnennung 4.0