Liberal transfusion strategy to prevent mortality and anaemia-associated, ischaemic events in elderly non-cardiac surgical patients (LIBERAL-Trial)

• Applicant: Professor Dr. Patrick Meybohm
• Subject Area: Anaesthesiology ; Biogerontology and Geriatric Medicine
• Term: since 2016
• Project identifier: Deutsche Forschungsgemeinschaft (DFG) - Project number 286575274

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. The LIBERAL Trial is a prospective, randomized, multicentre, controlled clinical phase IV trial randomising 2,470 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. Key secondary endpoints are percentage of patients transfused, number of RBC units, length of stay in hospital, length of stay on intensive care unit, acute kidney injury stage I-II, infections, re-hospitalisation, functional status (Barthel index), health-related quality of life, and composite components with 90 days and 1 year follow-up. We expect that until end of the 1st funding period (31.07.2022), we will have recruited 1625 patients (66%). This renewal proposal is necessary in order to allow us to continue recruitment and to randomize the remaining 34% of patients. In conclusion, 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)

• DFG Programme: Clinical Trials
• Co-Investigator: Professor Dr. Markus Velten