NCT04194437终止不适用
Prospective Trial to Evaluate the Effectiveness of The Portable Organ Care System (OCS) Liver for Preserving, Optimizing and Assessing Currently Seldom Utilized DCD Donor Livers for Transplantation
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- TransMedics
- 入组人数
- 9
- 试验地点
- 6
- 主要终点
- Liver Graft Survival Through 6 Months Post-transplant
研究概览
简要总结
Evaluate the safety and effectiveness of the OCS Liver System to preserve, optimize the condition, and assess levers from DCD donors.
详细描述
To evaluate the safety and effectiveness of the OCS™ Liver to preserve, optimize the condition and assess livers from DCD donors that currently are seldom used for liver transplants due to limitations of cold static storage with extended warm ischemic time and older donors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Registered primary liver transplant candidate
- •Age ≥ 18 years
- •Obtained informed consent
排除标准
- •Acute, fulminant liver failure
- •Prior solid organ or bone marrow transplant
- •Ventilator dependent on day of transplant/donor organ offer
研究组 & 干预措施
OCS Preserved Livers
Experimental
This is a single-arm trial of OCS preserved livers used for transplantation.
干预措施: OCS Liver System (Device)
结局指标
主要结局
Liver Graft Survival Through 6 Months Post-transplant
时间窗: 6 months
Evaluation of graft survival as defined per UNOS data collection criteria for graft status after liver transplantation
次要结局
未报告次要终点
研究者
研究点 (6)
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