TY  - JOUR
A1  - Meybohm, Patrick
A1  - Lindau, Simone
A1  - Treskatsch, Sascha
A1  - Francis, Roland
A1  - Spies, Claudia
A1  - Velten, Markus
A1  - Wittmann, Maria
A1  - Güresir, Erdem Özer
A1  - Stoppe, Christian
A1  - Kowark, Ana
A1  - Coburn, Mark
A1  - Selleng, Sixten
A1  - Baschin, Marcel
A1  - Jenichen, Gregor
A1  - Meersch, Melanie
A1  - Ermert, Thomas
A1  - Zarbock, Alexander
A1  - Kranke, Peter
A1  - Kredel, Markus
A1  - Helf, Antonia
A1  - Laufenberg-Feldmann, Rita
A1  - Ferner, Marion
A1  - Wittenmeier, Eva
A1  - Gürtler, Karl-Heinz
A1  - Kienbaum, Peter
A1  - Abreu, Marcelo Gama de
A1  - Sander, Michael
A1  - Bauer, Michael
A1  - Seyfried, Timo
A1  - Grünewald, Matthias Lars
A1  - Choorapoikayil, Suma
A1  - Müller, Markus M.
A1  - Seifried, Erhard
A1  - Brosteanu, Oana
A1  - Bogatsch, Holger
A1  - Hasenclever, Dirk
A1  - Zacharowski, Kai
T1  - Liberal transfusion strategy to prevent mortality and anaemia-associated, ischaemic events in elderly non-cardiac surgical patients – the study design of the LIBERAL-Trial
T2  - Trials
N2  - 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).
KW  - Red blood cell transfusion
KW  - anaemia
KW  - surgery
KW  - elderly patients
Y1  - 2019
UR  - http://publikationen.ub.uni-frankfurt.de/frontdoor/index/index/docId/49075
UR  - https://nbn-resolving.org/urn:nbn:de:hebis:30:3-490751
SN  - 1468-6694
SN  - 1745-6215
SN  - 1468-6708
N1  - 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.
VL  - 20
IS  - 1, Art. 101
SP  - 1
EP  - 10
PB  - BioMed Central
CY  - London
ER  -