Design, Analysis, and Pitfalls of Clinical Trials Using Ex Situ Liver Machine Perfusion: The International Liver Transplantation Society Consensus Guidelines. Issue 4 (25th March 2021)

• Record Type: Journal Article
• Authors: Martins, Paulo N.; Rizzari, Michael D.; Ghinolfi, Davide; Jochmans, Ina; Attia, Magdy; Jalan, Rajiv; Friend, Peter J.
• Other Names: contributor.; contributor.; Martins Paulo N. author non-byline.; contributor.; Rizzari Michael author non-byline.; contributor.; contributor.; Attia Magdy author non-byline.; contributor.; Ghinolfi David author non-byline.; contributor.; Jochmans Ina author non-byline.; contributor.; Jalan Rajiv author non-byline.; contributor.; Friend Peter author non-byline.; contributor.; contributor.; Broering Dieter author non-byline.; contributor.; Grat Michael author non-byline.; contributor.; Gugenheim Jean author non-byline.; contributor.; Guo Zhiyong author non-byline.; contributor.; Jacques Andrew author non-byline.; Marek Kysela author non-byline.; contributor.; Mas Valeria author non-byline.; contributor.; Patrono Damiano author non-byline.; contributor.; Dondossola Daniele author non-byline.; contributor.; Pomfret Elizabeth author non-byline.; contributor.; Ruiz Patricia author non-byline.; contributor.; Spiritelli Sandra author non-byline.; contributor.; Patkowski Waldemar author non-byline.; contributor.; DeMuylder Peter author non-byline.; contributor.; Ploeg Rutger author non-byline.; contributor.; Mergental Hynek author non-byline.; contributor.; contributor.; contributor.; contributor.; Abt Peter L. author non-byline.; contributor.; Attia Magdy author non-byline.; contributor.; CLAVIEN PIERRE-A. author non-byline.; contributor.; Cerisuelo Miriam Cortes author non-byline.; contributor.; Croome Kristopher P. author non-byline.; contributor.; Detry Olivier author non-byline.; contributor.; Pozzo Federica Dondero author non-byline.; contributor.; Dutkowski Philipp author non-byline.; contributor.; Foley David author non-byline.; contributor.; Fondevilla Constantino author non-byline.; contributor.; García-Valdecasas Salgado Juan Carlos author non-byline.; contributor.; Gastaca Mikel author non-byline.; contributor.; Ghinolfi Davide author non-byline.; contributor.; Guarrera James author non-byline.; contributor.; Guo Zhiyong author non-byline.; contributor.; Heaton Nigel author non-byline.; contributor.; Hernandez-Alejandro Roberto author non-byline.; contributor.; Hessheimer Amelia author non-byline.; contributor.; Jalan Rajiv author non-byline.; contributor.; Jochmans Ina author non-byline.; contributor.; Kalisvaart Marit author non-byline.; contributor.; Maluf Daniel author non-byline.; contributor.; Martins Paulo author non-byline.; contributor.; Miñambres Eduardo author non-byline.; contributor.; Muiesan Paolo author non-byline.; contributor.; Nasralla David author non-byline.; contributor.; Oniscu Gabriel author non-byline.; contributor.; Pirenne Jacques author non-byline.; contributor.; Polak Wojciech author non-byline.; contributor.; Porte Robert J. author non-byline.; contributor.; Quintini Cristiano author non-byline.; contributor.; Rizzari Michael author non-byline.; contributor.; Savier Eric author non-byline.; contributor.; Schlegel Andrea author non-byline.; contributor.; Taner C. Burcin author non-byline.; contributor.; Watson Christopher J.E. author non-byline.; contributor.;
• Is Part Of: Transplantation. Volume 105:Issue 4(2021)
• Page Start: 796
• Page End: 815
• Publication Date: 2021-03-25
• Subjects: Transplantation of organs, tissues, etc -- Periodicals; Transplantation immunology -- Periodicals; 617.95
• DOI: 10.1097/TP.0000000000003573
• Languages: English
• ISSNs: 0041-1337

Abstract

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