US National OCS Liver Perfusion (OLP) Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- TransMedics
- 入组人数
- 100,000
- 试验地点
- 22
- 主要终点
- Survival
研究概览
简要总结
This Registry is a sponsor-initiated, multi-center, observational, post-approval registry with an independent academic oversight.
TransMedics has contracted with United Network for Organ Sharing (UNOS) the Federal manager of the U.S. national transplant outcomes registry to obtain data that is routinely collected by the Organ Procurement and Transplantation Network (OPTN) on all transplanted organs in the U.S. for both the OCS liver transplanted patients as well as patients transplanted using other preservation modalities. Additional data will be collected by participating centers using OCS Liver perfusion.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Survival
时间窗: 5 years post-transplant
Recipients' patient and graft survival rates will be the primary clinical outcomes measures for all OCS Liver transplanted recipients compared to recipients receiving liver transplants using non-OCS preservation methods (cold static storage or other perfusion devices or a combination of both). This data will be obtained directly from UNOS/OPTN database.
次要结局
未报告次要终点