Meybohm, Patrick and Lindau, Simone and Treskatsch, Sascha and Francis, Roland and Spies, Claudia and Velten, Markus and Wittmann, Maria and Gueresir, Erdem and Stoppe, Christian and Kowark, Ana and Coburn, Mark and Selleng, Sixten and Baschin, Marcel and Jenichen, Gregor and Meersch, Melanie and Ermert, Thomas and Zarbock, Alexander and Kranke, Peter and Kredel, Markus and Helf, Antonia and Laufenberg-Feldmann, Rita and Ferner, Marion and Wittenmeier, Eva and Guertler, Karl-Heinz and Kienbaum, Peter and de Abreu, Marcel Gama and Sander, Michael and Bauer, Michael and Seyfried, Timo and Gruenewald, Matthias and Choorapoikayil, Suma and Mueller, Markus M. and Seifried, Erhard and Brosteanu, Oana and Bogatsch, Holger and Hasenclever, Dirk and Zacharowski, Kai and Baron, David and Grottke, Oliver and Hill, Aileen and Van Waesberghe, Julia and Van, Julia and Ziemann, Sebastian and Tingart, Markus and Van Essen, Julius and Spring, Oliver and Pirzer, Raphael and Jaschinski, Ulrich and Heller, Axel R. and Ertmer, Martin and Falk, Elke and Pickerodt, Philipp and Schiemann, Alexander and Schmidt, Katrin and Tafelski, Sascha and Trauzeddel, Ralf-Felix and Perka, Carsten and Ehrentraut, Heide and Fingehut, Louise and Hopf, Andreas and Guttenthaler, Vera and Neumann, Claudia and Osberghaus, Isabelle and Schuss, Patrick and Winkler, Anja and Kohlhof, Hendrik and Wirtz, Dieter C. and Kalb, Robert and Hinterberg, Jonas and Schaefer, Maximilian and Koch, Thea and Piekarski, Florian and Tanner, Linda and Berg, Kira and Wiedenbeck, Carolin and Maushagen, Isabell and Zeisset, Daniela and Fuellenbach, Christoph and Westphal, Sabine and Helmer, Philipp and Pfeiffer, Sophia and Schnitzbauer, Andreas and Marzi, Ingo and Becker, Andreas and Ghanaati, Shahram and Schmitz-Rixen, Thomas and Brixner, Verena and Geisen, Christof and Herrmann, Eva and Edinger, Fabian and Koch, Christian and Kunzemann, Christian and Leicht, Dominik and Markmann, Melanie and Ruhrmann, Sophie and Schneck, Emanuel and Schulte, Dargmar and Gruendling, Matthias and Brenig, Iris and Gerber, Manuela and Selleng, Kathleen and Wodrig, Sandra and Bloos, Frank and Bloos, Petra and Haucke, Anja and Knuhr-Kohlberg, Karina and Kolanos, Steffi and Schwope, Katrin and Thomas, Daniel and Buchholz, Corinna and Heller, Birte and Renner, Jochen and Schulz-Ruhtenberg, Nina and Elke, Gunnar and Fischer, Susanne and Hofbauer, Sabine and Straub, Peter and Zimmer, Sophie and Kuellmar, Mira and Rosenow, Nadine and Massoth, Christina and Weiss, Raphael and Bitzinger, Diane and Pfister, Karin and Guzman, Ines and Kranke, Eva-Maria and Roewer, Norbert and Woeckel, Achim (2019) Liberal transfusion strategy to prevent mortality and anaemia-associated, ischaemic events in elderly non-cardiac surgical patients - the study design of the LIBERAL-Trial. TRIALS, 20: 101. ISSN 1745-6215,
Full text not available from this repository. (Request a copy)Abstract
BackgroundPerioperative 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.MethodsThe 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.DiscussionThe 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).
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | BLOOD-CELL TRANSFUSION; RESTRICTIVE TRANSFUSION; OLDER-ADULTS; MANAGEMENT; GUIDELINES; MULTICENTER; THRESHOLDS; EQ-5D; Red blood cell transfusion; anaemia; surgery; elderly patients |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Anästhesiologie Medicine > Abteilung für Gefäßchirurgie |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 22 Apr 2020 05:46 |
| Last Modified: | 22 Apr 2020 05:46 |
| URI: | https://pred.uni-regensburg.de/id/eprint/27568 |
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