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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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, LIBERAL Collaboration Group
Аннотация
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 ).