Registry Analysis of Deceased Donor Kidney Transplant Outcomes With Normothermic Machine Perfusion (NMP)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 3,500
- 试验地点
- 1
- 主要终点
- Delayed Graft Function
研究概览
简要总结
This study uses existing transplant data obtained from a national public donor registry operated by the Organ Procurement and Transplant Network (OPTN) under Health Resources and Services Agency (HRSA) to evaluate outcomes associated with normothermic machine perfusion (NMP) of deceased donor kidneys. Currently, there is no method to study NMP kidney outcomes using the National Scientific Registry for Transplant Recipients (SRTR) national public registry, because no data field exists to identify which kidneys received NMP.
详细描述
This is a retrospective observational study using existing data from the Scientific Registry of Transplant Recipients (SRTR)/ Organ Procurement and Transplant Network (OPTN) public registry following a Research Plan approved by Health Resources & Services Agency (HRSA).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Requires kidney transplantation
排除标准
- •> 15 years old
研究组 & 干预措施
NMP Kidney Recipients
Patients receiving a kidney preserved and assessed using NMP
结局指标
主要结局
Delayed Graft Function
时间窗: 7 days post-transplantation
Requirement for dialysis immediately post kidney transplantation
Delayed Graft Function (DGF)
时间窗: 7 days
Requirement for dialysis within 7 days post kidney transplantation
次要结局
- Serum creatinine(Up to 3 years post-transplantation)
研究者
Chris Jaynes
PI, co-CEO
34 Lives, PBC