Pilot, Open, Monocentric, Randomized, Prospective Trial for the Evaluation of the Efficacy of Normothermic Perfusion Machine for Organ Preservation in Liver Transplantation Using Brain Death Donors Older or Equal Than 70 Years
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- 6 months graft survival
研究概览
简要总结
The purpose of this study is to evaluate the impact of normothermic machine perfusion in liver transplantation using grafts of brain death donors older or equal than 70 years
详细描述
Mean donor age for liver transplantation in Tuscany, Italy, is increasing and is actually 71 years. Old donors are a valuable resource but their use has been related to a major incidence of primary non function (PNF), delayed graft function (DGF) and ischemic type biliary lesions (ITBL).
Ischemia-reperfusion injury is a major reason for the development of these complications and and old grafts are more susceptible than younger ones.
Normothermic machine perfusion (NMP) is a novel and promising technique that allows preservation in a more physiological environment. It is our belief that the use of NMP might reduce the impact of ischemia-reperfusion injuries in older grafts thus reducing the incidence of complications and providing a better outcome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient on waiting list for liver transplant
- •Signed informed consent
- •Age between 18 and 70
- •Eligibility for liver transplant as for University of Pisa Liver Transplant Center Protocol
- •Capacity and willingness to participate to the protocol
排除标准
- •No signed informed consent
- •Age under 18 or over 70
- •Presence of disease that may influence results
- •Patient participation to other studies
- •Re-liver transplant
- •ABO incompatible OLT
- •Multiorgan transplant
- •Liver transplant for acute liver failure or trauma
- •MELD (model for end stage liver disease) >24
- •Patient not suitable to participate on investigators's opinion
结局指标
主要结局
6 months graft survival
时间窗: 180 days
次要结局
- Ischemia-reperfusion injury assessment through biopsies evaluation(1 day)
- Ischemia reperfusion injury assessment through incidence of ischemic type biliary lesions(180 days)
- ischemia reperfusion injury assessment through transaminases(7 days)
研究者
Davide Ghinolfi
Medical Doctor
Azienda Ospedaliero, Universitaria Pisana