Celsior®: Evaluation of an Organ Preservation Solution in Liver Transplantation.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 18
- 主要终点
- Graft failure leading to patient death or retransplantation
研究概览
简要总结
The aim of the study is to determine the efficacy and safety of a preservation solution in liver transplantation. Its efficacy will be compared to the efficacy of other currently used preservation solutions.
详细描述
The quality of organ preservation is a major determinant of initial graft function and survival. Graft viability is based on hypothermia, the organ being stored in a cold preservation solution.
Celsior® has been shown effective for cold preservation of heart and lung and, in laboratory studies, for liver, kidney and pancreas. The aim of the study is to evaluate the efficacy and safety of Celsior® in liver transplant preservation. Celsior® will be considered effective if the failure rate one year after transplantation is not significantly superior to 20% (rate observed in the European transplantation register between 1997 and 2001).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Primary liver transplantation
- •Whole organ transplantation
- •Agreement for a 1 year follow-up
- •Informed written consent
排除标准
- •Liver disease secondary to clotting abnormalities
- •Uncontrolled bacterial or viral disease at the time of transplantation
- •Combined transplantations
结局指标
主要结局
Graft failure leading to patient death or retransplantation
时间窗: 1 year
次要结局
- Onset and severity of hemodynamic troubles at reperfusion(Reperfusion after transplantation)
- Onset of surgical complications(1 year)
- Liver graft function during the fourteen first days(14 days)
- Incidence, treatment and evolution of acute and chronic rejections histologically proven(1 year)
- Onset of infections(1 year)
- Onset, treatment and evolution of serious adverse events(1 year)