NCT03176433Unknown1 期
A Multicentre, Single-arm, Prospective Clinical Trial to Investigate the Safety and Feasibility of Cold Storage Prior to Normothermic Machine Perfusion in Adult Human Liver Transplantation
适应症
试验速览
- 阶段
- 1 期
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Patient and Graft Survival
研究概览
简要总结
The aim of this study is to assess the safety and feasibility of a short period of cold storage prior to normothermic machine perfusion in adult liver transplantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Donors over the age of 16 years.
- •Liver allografts from donation after brain death (DBD), standard and extended criteria donors. (SCD, ECD) and donation after circulatory death (DCD) donors.
- •Liver must be perfused on OrganOx metra perfusion device within 8 hours of in situ cold perfusion.
- •The perfusion should last a minimum of 4 hours and maximum of 24 hours.
排除标准
- •Living donors.
- •Liver being transplanted as part of a multi-organ transplant (eg liver and kidney).
- •Liver intended for split transplant.
- •Donor age <16 years
- •Liver which investigator is unwilling to recruit to study.
- •Any liver in which logistics prevent perfusion on the OrganOx metra perfusion device within 8 hours of in situ cold perfusion.
- •Recipient Inclusion Criteria:
- •Adult patients (18 years or more).
- •Active on the waiting list for liver transplantation.
- •Able to give informed consent.
- •Recipient Exclusion Criteria:
- •Age less than 18 years.
- •Acute/fulminant liver failure.
- •Transplantation of more than one organ (e.g. liver and kidney).
- •Refusal of informed consent.
- •Unable to give informed consent.
结局指标
主要结局
Patient and Graft Survival
时间窗: 30 days
Patient survival after liver transplantation and liver graft survival will be assessed at 30-days post-op as a composite outcome measure. This will be recorded as yes/no outcome.
次要结局
- Primary non-function(10 days)
- Adverse events, transplantation and organ discard rates.(30 days)
- Biliary investigation or intervention(6 months)
- Patient and Graft Survival(12 months)
- Peak serum AST (U/L)(7 days)
- Early allograft dysfunction (EAD)(7 days)
研究者
研究点 (3)
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