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

Study Protocol

Emmanuel Nowak¹  Jacques Dantal²  Agnès Duveau³  Pierre Merville⁴  Nassim Kamar⁵  Jean-Philippe Rerolle⁶  Antoine Thierry⁷  Leonard Golbin⁸  Yannick Le Meur⁹  Matthias Buchler^1,10  Lionel Badet^1,11  Benoit Barrou^1,12  Leïla Demini^1,13  Franck Zal^1,13 

[1] Centre d’Investigation Clinique INSERM CIC 1412, Hôpital de La Cavale Blanche, CHRU de Brest, Brest, France;Public Agency for Clinical Research and Innovation (DRCI), Brest University Hospital, Brest, France;Department of Nephrology and Urology, CHU de Nantes, Nantes, France;Department of Nephrology and Urology, CHU d’Angers, Angers, France;Department of Nephrology and Urology, Hôpital Pellegrin, Bordeaux, France;Department of Nephrology and Urology, Hôpital Rangueil, CHU de Toulouse, Toulouse, France;Department of Nephrology, CHU Dupuytren, Limoges, France;Department of Nephrology, CHU La Milétrie, Poitiers, France;Department of Nephrology, CHU de Rennes, Rennes, France;Department of Nephrology, Hôpital de La Cavale Blanche, CHRU de Brest, Brest, France;Centre d’Investigation Clinique INSERM CIC 1412, Hôpital de La Cavale Blanche, CHRU de Brest, Brest, France;Department of Urology, Hôpital Bretonneau, CHRU de Tours, Tours, France;Department of Urology, Hôpital Edouard Herriot, Hospices Civils de Lyon, Lyon, France;Department of UrologyNephrology and Transplantation, Assistance Publique-Hôpitaux de Paris AP-HP, Hôpitaux Universitaire de La Pitié Salpétrière-Charles Foix, Paris, France;HEMARINA, Aéropôle Centre, Morlaix, France;

关键词: HEMOlife®;    Clinical trial;    Delayed Graft Function (DGF);    Transplantation;    Ischemia–Reperfusion Injury (IRI);    Kidney IRI;   

DOI  :  10.1186/s13063-023-07302-3

 received in 2023-02-21, accepted in 2023-04-06,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundPreventing 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.MethodsOxyOp2 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.DiscussionThe 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 registrationClinicalTrials.gov, ID: NCT04181710. registered on November 29, 2019.

【 授权许可】

CC BY   
© The Author(s) 2023

【 图 表 】

Fig. 3