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Abstract
There is a limited access to liver transplantation, however, many organs are discarded based on subjective assessment only. Here we report the VITTAL clinical trial (ClinicalTrials.gov number NCT02740608) outcomes, using normothermic machine perfusion (NMP) to objectively assess livers discarded by all UK centres meeting specific high-risk criteria. Thirty-one livers were enroled and assessed by viability criteria based on the lactate clearance to levels ≤2.5 mmol/L within 4 h. The viability was achieved by 22 (71%) organs, that were transplanted after a median preservation time of 18 h, with 100% 90-day survival. During the median follow up of 542 days, 4 (18%) patients developed biliary strictures requiring re-transplantation. This trial demonstrates that viability testing with NMP is feasible and in this study enabled successful transplantation of 71% of discarded livers, with 100% 90-day patient and graft survival; it does not seem to prevent non-anastomotic biliary strictures in livers donated after circulatory death with prolonged warm ischaemia.
The shortage of viable donated livers limits patient access to liver transplantation. Here the authors report the use of normothermic machine perfusion to help identify viable organs from livers discarded based on current clinical criteria, which are then transplanted to recipients in a single-arm clinical trial.
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1 University Hospitals Birmingham NHS Foundation Trust (UHBFT), Liver Unit, Queen Elizabeth Hospital, Birmingham, UK (GRID:grid.412563.7) (ISNI:0000 0004 0376 6589); University of Birmingham and University Hospitals Birmingham NHS Foundation Trust, National Institute for Health Research (NIHR), Birmingham Biomedical Research Centre, Birmingham, UK (GRID:grid.412563.7) (ISNI:0000 0004 0376 6589); University of Birmingham, Centre for Liver and Gastrointestinal Research, Institute of Immunology and Immunotherapy, Birmingham, UK (GRID:grid.6572.6) (ISNI:0000 0004 1936 7486)
2 University of Birmingham, Cancer Research UK Clinical Trials Unit, Birmingham, UK (GRID:grid.6572.6) (ISNI:0000 0004 1936 7486)
3 University Hospitals Birmingham NHS Foundation Trust (UHBFT), Liver Unit, Queen Elizabeth Hospital, Birmingham, UK (GRID:grid.412563.7) (ISNI:0000 0004 0376 6589)
4 University of Birmingham, D3B team, Cancer Research UK Clinical Trials Unit, Birmingham, UK (GRID:grid.6572.6) (ISNI:0000 0004 1936 7486)
5 University of Birmingham and University Hospitals Birmingham NHS Foundation Trust, National Institute for Health Research (NIHR), Birmingham Biomedical Research Centre, Birmingham, UK (GRID:grid.412563.7) (ISNI:0000 0004 0376 6589); University of Birmingham, Centre for Liver and Gastrointestinal Research, Institute of Immunology and Immunotherapy, Birmingham, UK (GRID:grid.6572.6) (ISNI:0000 0004 1936 7486)
6 University of Birmingham and University Hospitals Birmingham NHS Foundation Trust, National Institute for Health Research (NIHR), Birmingham Biomedical Research Centre, Birmingham, UK (GRID:grid.412563.7) (ISNI:0000 0004 0376 6589); University of Birmingham, Centre for Liver and Gastrointestinal Research, Institute of Immunology and Immunotherapy, Birmingham, UK (GRID:grid.6572.6) (ISNI:0000 0004 1936 7486); University Hospitals Birmingham NHS Foundation Trust (UHBFT), Department of Cellular Pathology, Queen Elizabeth Hospital, Birmingham, UK (GRID:grid.412563.7) (ISNI:0000 0004 0376 6589)
7 University Hospitals Birmingham NHS Foundation Trust (UHBFT), Liver Unit, Queen Elizabeth Hospital, Birmingham, UK (GRID:grid.412563.7) (ISNI:0000 0004 0376 6589); University of Birmingham, Centre for Liver and Gastrointestinal Research, Institute of Immunology and Immunotherapy, Birmingham, UK (GRID:grid.6572.6) (ISNI:0000 0004 1936 7486)
8 University Hospitals Birmingham NHS Foundation Trust (UHBFT), Liver Unit, Queen Elizabeth Hospital, Birmingham, UK (GRID:grid.412563.7) (ISNI:0000 0004 0376 6589); University of Birmingham and University Hospitals Birmingham NHS Foundation Trust, National Institute for Health Research (NIHR), Birmingham Biomedical Research Centre, Birmingham, UK (GRID:grid.412563.7) (ISNI:0000 0004 0376 6589)
9 University of Birmingham, Department of Intensive Care Medicine, Birmingham, UK (GRID:grid.6572.6) (ISNI:0000 0004 1936 7486)
10 OrganOx Limited, Oxford, UK (GRID:grid.487320.a)
11 OrganOx Limited, Oxford, UK (GRID:grid.487320.a); University of Oxford, Nuffield Department of Surgical Sciences, Oxford, UK (GRID:grid.4991.5) (ISNI:0000 0004 1936 8948)
12 University of Birmingham, Cancer Research UK Clinical Trials Unit, Birmingham, UK (GRID:grid.6572.6) (ISNI:0000 0004 1936 7486); The Institute of Cancer Research, Clinical Trials and Statistics Unit, London, UK (GRID:grid.18886.3f) (ISNI:0000 0001 1271 4623)