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Evaluation of the efficacy of HEMO(2)life®, a marine OXYgen carrier for Organ Preservation (OxyOp2) in renal transplantation: study protocol for a multicenter randomized trial

BACKGROUND: Preventing ischemia‒reperfusion injury (IRI) is a major issue in kidney transplantation, particularly for transplant recipients receiving a kidney from extended criteria donors (ECD). The main consequence of IRI is delayed graft function (DGF). Hypoxia is one of the key factors in IRI, s...

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Autores principales: Le Meur, Yannick, Nowak, Emmanuel, Barrou, Benoit, Thierry, Antoine, Badet, Lionel, Buchler, Matthias, Rerolle, Jean-Philippe, Golbin, Leonard, Duveau, Agnès, Dantal, Jacques, Merville, Pierre, Kamar, Nassim, Demini, Leïla, Zal, Franck
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10150461/
https://www.ncbi.nlm.nih.gov/pubmed/37127632
http://dx.doi.org/10.1186/s13063-023-07302-3
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author Le Meur, Yannick
Nowak, Emmanuel
Barrou, Benoit
Thierry, Antoine
Badet, Lionel
Buchler, Matthias
Rerolle, Jean-Philippe
Golbin, Leonard
Duveau, Agnès
Dantal, Jacques
Merville, Pierre
Kamar, Nassim
Demini, Leïla
Zal, Franck
author_facet Le Meur, Yannick
Nowak, Emmanuel
Barrou, Benoit
Thierry, Antoine
Badet, Lionel
Buchler, Matthias
Rerolle, Jean-Philippe
Golbin, Leonard
Duveau, Agnès
Dantal, Jacques
Merville, Pierre
Kamar, Nassim
Demini, Leïla
Zal, Franck
author_sort Le Meur, Yannick
collection PubMed
description BACKGROUND: Preventing ischemia‒reperfusion injury (IRI) is a major issue in kidney transplantation, particularly for transplant recipients receiving a kidney from extended criteria donors (ECD). The main consequence of IRI is delayed graft function (DGF). Hypoxia is one of the key factors in IRI, suggesting that the use of an oxygen carrier as an additive to preservation solution may be useful. In the OxyOp trial, we showed that the organs preserved using the oxygen carrier HEMO2life® displayed significantly less DGF. In the OxyOp2 trial, we aim to definitively test and quantify the efficacy of HEMO2life® for organ preservation in a large population of kidney grafts. METHODS: OxyOp2 is a prospective, multicenter, randomized, comparative, single-blinded, parallel-group study versus standard of care in renal transplantation. After the selection of a suitable donor according to the inclusion/exclusion criteria, both kidneys will be used in the study. Depending on the characteristics of the donor, both kidneys will be preserved either in static cold storage (standard donors) or on machine perfusion (for ECD and deceased-after-cardiac-death donors (DCD)). The kidneys resulting from one donor will be randomized: one to the standard-of-care arm (organ preserved in preservation solution routinely used according to the local practice) and the other to the active treatment arm (HEMO2life® on top of routinely used preservation solution). HEMO2life® will be used for ex vivo graft preservation at a dose of 1 g/l preservation solution. The primary outcome is the occurrence of DGF, defined as the need for renal replacement therapy during the first week after transplantation. DISCUSSION: The use of HEMO2life® in preservation solutions is a novel approach allowing, for the first time, the delivery of oxygen to organs. Improving graft survival by limiting ischemic lesions is a major public-health goal in the field of organ transplantation. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT04181710. registered on November 29, 2019.
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spelling pubmed-101504612023-05-02 Evaluation of the efficacy of HEMO(2)life®, a marine OXYgen carrier for Organ Preservation (OxyOp2) in renal transplantation: study protocol for a multicenter randomized trial Le Meur, Yannick Nowak, Emmanuel Barrou, Benoit Thierry, Antoine Badet, Lionel Buchler, Matthias Rerolle, Jean-Philippe Golbin, Leonard Duveau, Agnès Dantal, Jacques Merville, Pierre Kamar, Nassim Demini, Leïla Zal, Franck Trials Study Protocol BACKGROUND: Preventing ischemia‒reperfusion injury (IRI) is a major issue in kidney transplantation, particularly for transplant recipients receiving a kidney from extended criteria donors (ECD). The main consequence of IRI is delayed graft function (DGF). Hypoxia is one of the key factors in IRI, suggesting that the use of an oxygen carrier as an additive to preservation solution may be useful. In the OxyOp trial, we showed that the organs preserved using the oxygen carrier HEMO2life® displayed significantly less DGF. In the OxyOp2 trial, we aim to definitively test and quantify the efficacy of HEMO2life® for organ preservation in a large population of kidney grafts. METHODS: OxyOp2 is a prospective, multicenter, randomized, comparative, single-blinded, parallel-group study versus standard of care in renal transplantation. After the selection of a suitable donor according to the inclusion/exclusion criteria, both kidneys will be used in the study. Depending on the characteristics of the donor, both kidneys will be preserved either in static cold storage (standard donors) or on machine perfusion (for ECD and deceased-after-cardiac-death donors (DCD)). The kidneys resulting from one donor will be randomized: one to the standard-of-care arm (organ preserved in preservation solution routinely used according to the local practice) and the other to the active treatment arm (HEMO2life® on top of routinely used preservation solution). HEMO2life® will be used for ex vivo graft preservation at a dose of 1 g/l preservation solution. The primary outcome is the occurrence of DGF, defined as the need for renal replacement therapy during the first week after transplantation. DISCUSSION: The use of HEMO2life® in preservation solutions is a novel approach allowing, for the first time, the delivery of oxygen to organs. Improving graft survival by limiting ischemic lesions is a major public-health goal in the field of organ transplantation. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT04181710. registered on November 29, 2019. BioMed Central 2023-05-01 /pmc/articles/PMC10150461/ /pubmed/37127632 http://dx.doi.org/10.1186/s13063-023-07302-3 Text en © The Author(s) 2023 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Study Protocol
Le Meur, Yannick
Nowak, Emmanuel
Barrou, Benoit
Thierry, Antoine
Badet, Lionel
Buchler, Matthias
Rerolle, Jean-Philippe
Golbin, Leonard
Duveau, Agnès
Dantal, Jacques
Merville, Pierre
Kamar, Nassim
Demini, Leïla
Zal, Franck
Evaluation of the efficacy of HEMO(2)life®, a marine OXYgen carrier for Organ Preservation (OxyOp2) in renal transplantation: study protocol for a multicenter randomized trial
title Evaluation of the efficacy of HEMO(2)life®, a marine OXYgen carrier for Organ Preservation (OxyOp2) in renal transplantation: study protocol for a multicenter randomized trial
title_full Evaluation of the efficacy of HEMO(2)life®, a marine OXYgen carrier for Organ Preservation (OxyOp2) in renal transplantation: study protocol for a multicenter randomized trial
title_fullStr Evaluation of the efficacy of HEMO(2)life®, a marine OXYgen carrier for Organ Preservation (OxyOp2) in renal transplantation: study protocol for a multicenter randomized trial
title_full_unstemmed Evaluation of the efficacy of HEMO(2)life®, a marine OXYgen carrier for Organ Preservation (OxyOp2) in renal transplantation: study protocol for a multicenter randomized trial
title_short Evaluation of the efficacy of HEMO(2)life®, a marine OXYgen carrier for Organ Preservation (OxyOp2) in renal transplantation: study protocol for a multicenter randomized trial
title_sort evaluation of the efficacy of hemo(2)life®, a marine oxygen carrier for organ preservation (oxyop2) in renal transplantation: study protocol for a multicenter randomized trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10150461/
https://www.ncbi.nlm.nih.gov/pubmed/37127632
http://dx.doi.org/10.1186/s13063-023-07302-3
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