Centre for Clinical Research, Hospices Civils de Lyon, Croix-Rousse University Hospital, Lyon, France.
Department of Pharmacy, Croix-Rousse University Hospital, Hospices Civils de Lyon, Lyon, France.
Trials. 2023 Jun 6;24(1):379. doi: 10.1186/s13063-023-07402-0.
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.
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.
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.
ClinicalTrials.gov NCT03929523. Registered on April 29, 2019, before the start of inclusion.
由于供体稀缺，越来越多的所谓边缘或扩展标准供体 (ECD) 器官被用于肝移植。然而，由于对缺血再灌注损伤的敏感性更高，这些 ECD 肝移植物与更高的早期移植物功能障碍和原发性无功能的发生率相关。终末缺血低温氧合机器灌注 (HOPE) 技术可通过减少再灌注损伤来改善 ECD 移植物肝移植的结果。
HOPExt 试验是一项比较的、开放标签的、多中心的、全国性的、前瞻性的、随机对照研究，分为两组，使用静态冷保存作为对照，这是金标准。试验将纳入肝衰竭或肝硬化和/或肝恶性肿瘤需要肝移植并接受脑死亡供体 ECD 肝移植物的移植等待名单上的成年患者。在实验组中，ECD 肝移植物首先进行经典的低温（4°C）保存，然后进行低温氧合灌注（HOPE）1 至 4 小时。对照组将包括经典的静态冷存储，这是肝移植的金标准程序。该试验的主要目的是研究 ECD 脑死亡供体肝移植物移植前使用 HOPE 减少术后 7 天内早期移植物功能障碍的效果，与单纯冷静态存储相比。
我们在本方案中介绍了 HOPExt 试验的所有研究程序，以防止对试验结果的分析偏倚并提高试验结果的透明度。HOPExt 试验的患者招募已于 2019 年 9 月 10 日开始，正在进行中。
ClinicalTrials.gov NCT03929523。于 2019 年 4 月 29 日在纳入前注册。
