End-ischemic hypothermic oxygenated perfusion for extended criteria donors in liver transplantation: a multicenter, randomized controlled trial-HOPExt.

Abstract

BACKGROUND:

Given the scarce donor supply, an increasing number of so-called marginal or extended criteria donor (ECD) organs are used for liver transplantation. These ECD liver grafts are however known to be associated with a higher rate of early allograft dysfunction and primary non-function because of a greater vulnerability to ischemia-reperfusion injury. The end-ischemic hypothermic oxygenated machine perfusion (HOPE) technique may improve outcomes of liver transplantation with ECD grafts by decreasing reperfusion injury.

METHODS:

HOPExt trial is a comparative open-label, multicenter, national, prospective, randomized, controlled study, in two parallel groups, using static cold storage, the gold standard procedure, as control. The trial will enroll adult patients on the transplant waiting list for liver failure or liver cirrhosis and/or liver malignancy requiring liver transplantation and receiving an ECD liver graft from a brain-dead donor. In the experimental group, ECD liver grafts will first undergo a classical static cold (4 °C) storage followed by a hypothermic oxygenated perfusion (HOPE) for a period of 1 to 4 h. The control group will consist of the classic static cold storage which is the gold standard procedure in liver transplantation. The primary objective of this trial is to study the efficacy of HOPE used before transplantation of ECD liver grafts from brain-dead donors in reducing postoperative early allograft dysfunction within the first 7 postoperative days compared to simple cold static storage.

DISCUSSION:

We present in this protocol all study procedures in regard to the achievement of the HOPExt trial, to prevent biased analysis of trial outcomes and improve the transparency of the trial results. Enrollment of patients in the HOPExt trial has started on September 10, 2019, and is ongoing.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT03929523. Registered on April 29, 2019, before the start of inclusion.

• Authors: Pierre Pradat, Solene Pantel, Marianne Maynard, Laure Lalande, Sylvie Thevenon, Rene Adam, Marc-Antoine Allard, Fabien Robin, Michel Rayar, Emmanuel Boleslawski, Olivier Scatton, Mircea Chirica, François Faitot, Philippe Bachellier, Olivier Soubrane, Kayvan Mohkam, Jean-Yves Mabrut, Mickaël Lesurtel
• Journal: Trials (Trials) Vol. 24 Issue 1 Pg. 379 (Jun 06 2023) ISSN: 1745-6215 [Electronic] England
• PMID: 37280696 (Publication Type: Randomized Controlled Trial, Multicenter Study, Journal Article)
• Copyright: © 2023. The Author(s).

Topics

• Adult
• Humans
• Liver Transplantation (adverse effects, methods)
• Prospective Studies
• Organ Preservation (adverse effects)
• Tissue Donors
• Liver (pathology)
• Reperfusion Injury (etiology, prevention & control)
• Perfusion (adverse effects, methods)
• Graft Survival