NCT05074160进行中（未招募）不适用
OCS Liver Perfusion (OLP) Post-Approval Registry
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- TransMedics
- 入组人数
- 166
- 试验地点
- 9
- 主要终点
- Patient Survival
研究概览
简要总结
The objective of the OLP Registry is to collect more data on the post-transplant clinical outcomes of DBD and DCD donor livers preserved and assessed on OCS Liver System according to the approved indication and the OCS device performance in the real-world setting.
详细描述
OLP Registry is a multi-center, observational post-approval registry of adult primary liver transplant recipients who are transplanted with an OCS Liver-perfused DBD or DCD donor liver according to the approved indication and that match the eligibility criteria below.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
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
- •Adult primary liver transplant recipients of DBD or DCD donor Livers perfused on OCS Liver System
排除标准
- •Donor livers with accessory arterial blood supply requiring back table anastomosis, major traumatic injury, or hematoma; or
- •Split donor liver; or
- •DCD donor liver with >30 minutes of warm ischemic time (defined as from withdrawal of life support until donor liver cold flush); or
- •DCD donors age >55 years; or
- •DCD donor liver with macrosteatosis of >15%
- •Living donors
- •Donors with positive serology for HIV, Hep B and C
- •Donors with macrosteatosis of ≥40%
- •Recipient Exclusion Criteria:
- •Fulminant liver failure; or
- •Concurrent (multi-organ transplant) or previous solid organ or bone marrow transplant; or
- •Chronic renal dialysis at time of transplant; or
- •Dependency on more than 1 inotropic agent to maintain hemodynamics; or
- •Ventilator dependent at time of transplant.
结局指标
主要结局
Patient Survival
时间窗: 1 year post-Liver transplant
1-year patient survival with the originally transplanted liver (patient and graft survival) post-Liver transplant.
次要结局
未报告次要终点
研究者
研究点 (9)
Loading locations...
相似试验
招募中
不适用
US National OCS Liver Perfusion (OLP) RegistryLiver TransplantNCT05940857TransMedics100,000
招募中
不适用
US National TOP RegistryLung TransplantNCT06513091TransMedics10,000
进行中（未招募）
不适用
OCS Heart Perfusion Post-Approval RegistryTransplantNCT05047068TransMedics350
已完成
不适用
OCS Liver PROTECT Continuation Post-Approval StudyLiver TransplantNCT05096741TransMedics300
已完成
不适用
OCS Liver PROTECT Continued Access Protocol (CAP) Continuation Post-Approval StudyLiver TransplantNCT05096754TransMedics74