Prospective Observational Study to Investigate Long-term Outcomes After Prolonged Dual Hypothermic Oxygenated Machine Perfusion of Human Donor Livers (DHOPEPROLONG)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Death-censored graft survival
研究概览
简要总结
End-ischemic dual hypothermic oxygenated machine perfusion (DHOPE) of human donor livers mitigates ischemia-reperfusion injury, resulting in a reduction of post-reperfusion syndrome, early allograft dysfunction and biliary complications, when compared with static cold storage. End-ischemic DHOPE can be used to prolong donor liver preservation time for up to 24 hours. According to IDEAL-D (Idea, Development, Exploration, Assessment, Long term study-Framework for Devices), scientific evidence for prolonged DHOPE has currently reached stage 3. Assessment of long-term outcomes after prolonged DHOPE preservation based on real-world data (i.e., IDEAL-D stage 4) is currently still lacking.
详细描述
The aim of this study is to assess long-term outcomes after transplantation of donor livers preserved by prolonged hypothermic oxygenated machine perfusion (DHOPE-PRO).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (>18 years) who underwent liver transplantation of donor livers preserved with end-ischemic DHOPE for >4 hours
排除标准
- 未提供
结局指标
主要结局
Death-censored graft survival
时间窗: Up to 5-years
Death-censored graft survival, assessed by survival analysis methods.
次要结局
- incidence of re-transplantation(Up to 5-years)
- overall patient survival(Up to 5-years)
- incidence of acute cellular rejection(Up to 5-years)
- incidence of chronic rejection(Up to 5-years)
- Overall graft survival(Up to 5-years)
- arterial and biliary complication-free survival (ABCFS)(Up to 5-years)
- incidence of biliary complications(Up to 5-years)
- incidence of vascular complications(Up to 5-years)
- incidence of recurrence of primary disease(Up to 5-years)
- incidence of new-onset chronic kidney disease(Up to 5-years)
- incidence of new-onset diabetes after transplantation(Up to 5-years)