Design, Analysis, and Pitfalls of Clinical Trials Using Ex Situ Liver Machine Perfusion: The International Liver Transplantation Society Consensus Guidelines

Export Background. Recent trials in liver machine perfusion (MP) have revealed unique challenges beyond those seen most clinical studies. Correct trial design and interpretation of data are essential to avoid drawing conclusions that may compromise patient safety increase costs. Methods. The International Liver Transplantation Society, through the Special Interest Group “DCD, Preservation Machine Perfusion,” established a working group write consensus statements guidelines on how future should be designed, with particular focus relevant endpoints different techniques compared. Protocols, abstracts, full published papers using MP were reviewed. use simplified Grading Recommendations Assessment, Development, Evaluation (GRADE) system was attempted assess level evidence. presented its at Society conference Preservation, Perfusion” held Venice, Italy, January 31, 2020. Results. Twelve recommendations proposed main investigating effect transplantation (1) make protocol publicly available before start trial, (2) adequately powered, (3) carefully consider timing randomization function primary outcome. Conclusions. There issues accepted outcomes context trials, no ideal endpoint could defined by group. setup an international registry considered vital