Evaluation of the efficacy of HEMO2life®, a marine OXYgen carrier for Organ Preservation (OxyOp2) in renal transplantation: study protocol for a multicenter randomized trial
Abstract 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 i...
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| Format: | Article |
| Language: | English |
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BMC
2023-05-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-023-07302-3 |
| _version_ | 1797831864233230336 |
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| author | Yannick Le Meur Emmanuel Nowak Benoit Barrou Antoine Thierry Lionel Badet Matthias Buchler Jean-Philippe Rerolle Leonard Golbin Agnès Duveau Jacques Dantal Pierre Merville Nassim Kamar Leïla Demini Franck Zal |
| author_facet | Yannick Le Meur Emmanuel Nowak Benoit Barrou Antoine Thierry Lionel Badet Matthias Buchler Jean-Philippe Rerolle Leonard Golbin Agnès Duveau Jacques Dantal Pierre Merville Nassim Kamar Leïla Demini Franck Zal |
| author_sort | Yannick Le Meur |
| collection | DOAJ |
| description | Abstract 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. |
| first_indexed | 2024-04-09T13:59:38Z |
| format | Article |
| id | doaj.art-15a59dfe9ffe4efead931ae66f719360 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-04-09T13:59:38Z |
| publishDate | 2023-05-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-15a59dfe9ffe4efead931ae66f7193602023-05-07T11:22:55ZengBMCTrials1745-62152023-05-0124111310.1186/s13063-023-07302-3Evaluation of the efficacy of HEMO2life®, a marine OXYgen carrier for Organ Preservation (OxyOp2) in renal transplantation: study protocol for a multicenter randomized trialYannick Le Meur0Emmanuel Nowak1Benoit Barrou2Antoine Thierry3Lionel Badet4Matthias Buchler5Jean-Philippe Rerolle6Leonard Golbin7Agnès Duveau8Jacques Dantal9Pierre Merville10Nassim Kamar11Leïla Demini12Franck Zal13Department of Nephrology, Hôpital de La Cavale Blanche, CHRU de BrestCentre d’Investigation Clinique INSERM CIC 1412, Hôpital de La Cavale Blanche, CHRU de BrestDepartment of UrologyNephrology and Transplantation, Assistance Publique-Hôpitaux de Paris AP-HP, Hôpitaux Universitaire de La Pitié Salpétrière-Charles FoixDepartment of Nephrology, CHU La MilétrieDepartment of Urology, Hôpital Edouard Herriot, Hospices Civils de LyonDepartment of Urology, Hôpital Bretonneau, CHRU de ToursDepartment of Nephrology, CHU DupuytrenDepartment of Nephrology, CHU de RennesDepartment of Nephrology and Urology, CHU d’AngersDepartment of Nephrology and Urology, CHU de NantesDepartment of Nephrology and Urology, Hôpital PellegrinDepartment of Nephrology and Urology, Hôpital Rangueil, CHU de ToulouseHEMARINA, Aéropôle CentreHEMARINA, Aéropôle CentreAbstract 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.https://doi.org/10.1186/s13063-023-07302-3HEMO2life®Clinical trialDelayed Graft Function (DGF)TransplantationIschemia–Reperfusion Injury (IRI)Kidney IRI |
| spellingShingle | Yannick Le Meur Emmanuel Nowak Benoit Barrou Antoine Thierry Lionel Badet Matthias Buchler Jean-Philippe Rerolle Leonard Golbin Agnès Duveau Jacques Dantal Pierre Merville Nassim Kamar Leïla Demini Franck Zal Evaluation of the efficacy of HEMO2life®, a marine OXYgen carrier for Organ Preservation (OxyOp2) in renal transplantation: study protocol for a multicenter randomized trial Trials HEMO2life® Clinical trial Delayed Graft Function (DGF) Transplantation Ischemia–Reperfusion Injury (IRI) Kidney IRI |
| title | Evaluation of the efficacy of HEMO2life®, 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 HEMO2life®, 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 HEMO2life®, 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 HEMO2life®, 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 HEMO2life®, 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 hemo2life r a marine oxygen carrier for organ preservation oxyop2 in renal transplantation study protocol for a multicenter randomized trial |
| topic | HEMO2life® Clinical trial Delayed Graft Function (DGF) Transplantation Ischemia–Reperfusion Injury (IRI) Kidney IRI |
| url | https://doi.org/10.1186/s13063-023-07302-3 |
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