A Prospective Randomized Multicenter Trial Comparing Histidine-Tryptophane-Ketoglutarate (HTK) Versus University of Wisconsin (UW) Perfusion Solution in Clinical Pancreas Transplantation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 8
- 主要终点
- Pancreas graft survival
研究概览
简要总结
Graft preservation in clinical pancreas transplantation is based on hypothermia achieved by topic cooling and cold in situ flushing using special perfusion solutions designed to attenuate the effects of ischemia/reperfusion and prolong cold ischemia tolerance.
For pancreas transplantation, University of Wisconsin (UW) solution is the most commonly used perfusate. However, over the last years, Histidine-Tryptophan-Ketoglutarate (HTK) solution has been increasingly used for abdominal organ procurement. Retrospective reports published so far have demonstrated the safety of both perfusion solutions.
However, to date, no prospective study comparing both perfusion solutions has been published. Aim of this study was to prospectively evaluate early pancreas graft function in clinical pancreas transplantation after organ perfusion with HTK vs. UW solution.
The study hypothesis is that HTK is not inferior to UW for organ perfusion during procurement in clinical pancreas transplantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •brain dead, heart beating organ donor
- •donor age 10 - 50 years
- •donor body mass index < 30kg/m2
- •pancreas cold ischemia time < 20 hours
- •written informed consent of the pancreas recipient
排除标准
- •missing written consent
- •pancreas retransplantation
- •recipient participation in another study
结局指标
主要结局
Pancreas graft survival
时间窗: 6 months after transplantation
次要结局
- Serum amylase(6 months after transplantation)
- Serum lipase(6 months after transplantation)
- C-peptide(6 months after transplantation)
- HbA1c(6 months after transplantation)
- Exogenous insulin requirement(6 months after transplantation)