Interest of Oxygenated Hypothermic Perfusion in Preservation of Hepatic Grafts From Expanded Criteria Donors. A Prospective Monocentric Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Evaluation of the performance of HOPE in the preservation of ECD liver grafts on graft function recovery
研究概览
简要总结
Interest of oxygenated hypothermic perfusion in preservation of hepatic grafts from expanded criteria donors.
详细描述
The excellent results of liver transplantation (LT) have led to a significant increase in the number of patients awaiting transplantation. At the same time, the number of grafts remains stable. To extend the donor pool, the use of Extended Criteria Donor (ECD) donors graft increased each year despite the fact that these graft are known to be more vulnerable to ischemia-reperfusion injuries induced by cold storage preservation (CS). Their use is therefore associated with a greater risk of postoperative dysfunction of the graft. This risk can be reduced by improving preservation quality.
The preservation by hypothermic oxygenated perfusion (HOPE) consists of keeping the graft in hypothermia (4 to 12 °C) on an machine perfusion (MP) using a specific solution, saturated with oxygen. In kidney transplantation, the use of MP has been shown to improve graft function as well as graft survival, especially for ECD grafts.
In liver transplantation, experimental studies on animal models have demonstrated the superiority of HOPE over CS regarding graft function and survival. These results have been confirmed in humans on small retrospective series.
As HOPE is an expensive procedure, obtaining evidence of its effectiveness could result in a reimbursement of the additional cost.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients older than 18 years
- •Candidates for a first orthotopic liver transplantation, without transplantation of another associated organ (kidney, pancreas, heart, lung, intestine)
- •With cirrhosis whatever its etiology and gravity
- •With or without hepatocarcinoma
- •Having given free, informed and written consent
- •LT made from a whole graft, harvested from a brain-dead donor with ECD criteria, defined as the presence of at least one of the following criteria:
- •Age> 65 years
- •BMI> 30 kg / m2
- •Duration of hospitalization in intensive care unit> 7 days
- •Natremia> 155 mmol / l
- •AST> 150 IU / ml
- •ALT> 170 IU / ml
- •Occurrence of cardiac arrest before harvesting
- •Macrovacuolar steatosis> 30% on liver histology
排除标准
- •History of organ transplantation
- •Transplantation in emergency
- •Transplantation from a living donor, a reduced graft or a graft from a deceased donor by cardiac arrest (DCD)
- •Major persons subject to legal protection (safeguard of justice, guardianship), persons deprived of their liberty
研究组 & 干预措施
Conventional cold storage
干预措施: Conventional cold storage (Other)
Hypothermic oxygenated perfusion (HOPE)
Application of HOPE for 2 hours
干预措施: Hypothermic oxygenated perfusion (HOPE) (Device)
结局指标
主要结局
Evaluation of the performance of HOPE in the preservation of ECD liver grafts on graft function recovery
时间窗: Day 7
Occurrence of early allograft dysfunction and / or primary non function
次要结局
- Number of days of hospitalization after transplantation(Month 3)
- Evaluation of the impact of PHO during the conservation of ECD liver grafts on postoperative morbidity(Day 7)
- Evaluation of graft's survival(Month 3)
- Number of days of hospitalization (initial stay) after transplantation(Postoperative course)
- Cost of the initial stay(Postoperative course)
- Cost of the hospitalization stay(Month 3)
- Evaluation of the impact of PHO during the conservation of ECD liver grafts on intraoperative morbidity(Day 1)