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

Meybohm, Patrick

; Lindau, Simone ; Treskatsch, Sascha ; Francis, Roland

; Spies, Claudia

; Velten, Markus ; Wittmann, Maria ; Gueresir, Erdem ; Stoppe, Christian ; Kowark, Ana ; Coburn, Mark ; Selleng, Sixten ; Baschin, Marcel ; Jenichen, Gregor ; Meersch, Melanie ; Ermert, Thomas ; Zarbock, Alexander ; Kranke, Peter ; Kredel, Markus ; Helf, Antonia ; Laufenberg-Feldmann, Rita ; Ferner, Marion ; Wittenmeier, Eva ; Gürtler, Karl-Heinz ; Kienbaum, Peter ; de Abreu, Marcel Gama ; Sander, Michael

; Bauer, Michael ; Seyfried, Timo ; Gruenewald, Matthias ; Choorapoikayil, Suma ; Mueller, Markus M. ; Seifried, Erhard ; Brosteanu, Oana ; Bogatsch, Holger ; Hasenclever, Dirk ; Zacharowski, Kai

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Abstract

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 ( 70years) patients undergoing intermediate- or high-risk non-cardiac surgery. Registered patients will be randomised only if Haemoglobin (Hb) reaches 9g/dl during surgery or within 3days after surgery either to the LIBERAL group (transfusion of a single RBC unit when Hb9g/dl with a target range for the post-transfusion Hb level of 9-10.5g/dl) or the RESTRICTIVE group (transfusion of a single RBC unit when Hb7.5g/dl with a target range for the post-transfusion Hb level of 7.5-9g/dl). The intervention per patient will be followed until hospital discharge or up to 30days 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 90days 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 90days after surgery.Trial registrationClinicalTrials.gov (identifier: NCT03369210).

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

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