NCT03694691招募中不适用
Development of a Liver Viability Index for Transplantation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Peak transaminase value post transplant
研究概览
简要总结
Machine perfusion technology is nearing the point of rescuing discarded liver grafts in the hope of proving them to be or improving them to the point of being transplantable. However, there are no validated metrics to determine transplantability after machine perfusion. This study involves collecting biopsies from transplanted livers before and after implantation to correlate metabolite and gene expression with post-transplant function. This data will help develop a viability index for machine perfused livers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female 18-75 years of age.
- •Candidate for a deceased-donor liver allograft.
排除标准
- •Seropositivity for HIV-1.
结局指标
主要结局
Peak transaminase value post transplant
时间窗: 1 Year
The primary endpoint is peak transaminase values since transaminase elevation is a marker of hepatocyte injury
次要结局
- Liver Graft Failure(1 Year)
- Death(1 Year)
- Kidney Failure(1 Year)
- Acute Liver Rejection(1 Year)
- Incidence of major Infection(1 Year)
- Hepatitis C Recurrence (in Hepatitis C positive recipients)(1 Year)
- Biliary Complications(1 Year)
研究者
Heidi Yeh
Associate Professor
Massachusetts General Hospital
研究点 (2)
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