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.
Trials. 2023 May 1;24(1):302. doi: 10.1186/s13063-023-07302-3.
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.
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.
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.
ClinicalTrials.gov, ID: NCT04181710 . registered on November 29, 2019.
预防缺血再灌注损伤（IRI）是肾移植中的一个主要问题，特别是对于接受来自扩展标准供体（ECD）的肾脏的移植受者。IRI 的主要后果是延迟移植物功能（DGF）。缺氧是 IRI 的关键因素之一，这表明使用氧载体作为保存液的添加剂可能是有用的。在 OxyOp 试验中，我们表明使用氧载体 HEMO2life®保存的器官明显较少出现 DGF。在 OxyOp2 试验中，我们旨在在大量的肾脏移植供体中，明确测试和量化 HEMO2life®对器官保存的疗效。
OxyOp2 是一项前瞻性、多中心、随机、对照、单盲、平行组研究，与肾移植中的标准护理进行比较。根据纳入/排除标准选择合适的供体后，将使用供体的两个肾脏进行研究。根据供体的特点，两个肾脏将分别在静态冷藏（标准供体）或机器灌注（ECD 和死后心脏死亡供体（DCD））中保存。来自一个供体的肾脏将随机分配：一个进入标准护理组（用根据当地实践常规使用的保存液保存器官），另一个进入活性治疗组（在常规使用的保存液上加用 HEMO2life®）。HEMO2life®将用于离体移植保存，剂量为 1g/L 保存液。主要结局是发生 DGF，定义为移植后第一周需要肾脏替代治疗。
在保存液中使用 HEMO2life®是一种新方法，首次允许向器官输送氧气。通过限制缺血性损伤来提高移植物存活率是器官移植领域的一个主要公共卫生目标。
ClinicalTrials.gov，ID：NCT04181710，于 2019 年 11 月 29 日注册。
