Assessment of Long-term Outcomes After Transplantation of Donor Livers Preserved by Hypothermic Oxygenated Machine Perfusion (HOPE): a Retrospective Cohort Analysis of Real-world Data (IDEAL-D Stage 4)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,202
- 试验地点
- 2
- 主要终点
- Death-censored graft survival, assessed by survival analysis methods
研究概览
简要总结
End-ischemic hypothermic oxygenated machine perfusion (HOPE) 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. According to IDEAL-D (Idea, Development, Exploration, Assessment, Long term study-Framework for Devices), with several published randomized controlled trials on short-to-medium term outcomes, scientific evidence for HOPE has currently reached stage 3. Assessment of long-term outcomes after HOPE preservation based on real-world data (i.e., IDEAL-D stage 4) is currently still lacking. Therefore, we aim to conduct an international, multi-center, retrospective, observational cohort study to assess long-term outcomes after transplantation of donor livers preserved by hypothermic oxygenated machine perfusion (HOPE).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patients (>18 years) who underwent liver transplantation of donor livers preserved with end-ischemic HOPE (including donation after normothermic regional perfusion) between 01.01.2012 and 31.12.2021.
排除标准
- •Simultaneous multiorgan transplantations, sequential normothermic machine perfusion (e.g., DHOPE-COR-NMP, but not NRP), living partial liver donation.
结局指标
主要结局
Death-censored graft survival, assessed by survival analysis methods
时间窗: Up to 5-years
Defined as time from liver transplantation until re-transplantation or death due to graft dysfunction
次要结局
- Incidence of biliary complications(Up to 5-years)
- Incidence of vascular complications(Up to 5-years)
- Incidence of re-transplantation(Up to 5-years)
- Incidence of acute cellular rejection(Up to 5-years)
- Incidence of recurrence of primary disease (including recurrence of malignancies)(Up to 5-years)
- Overall graft survival(Up to 5-years)
- Overall patient survival(Up to 5-years)
- Arterial and biliary complication-free survival (ABCFS)(Up to 5-years)
- Incidence of chronic rejection(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)