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临床试验/NCT04764266
NCT04764266已完成不适用

Glycocalyx Damage During Normothermic Graft Perfusion in Orthotopic Liver Transplantation - A Pilot Study

Medical University Innsbruck2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年2月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
2
主要终点
Syndecan 1 level during normothermic machine perfusion

研究概览

简要总结

An organ intended for transplantation is normally stored on ice (cold storage, CS) after explantation from the donor. During this storage process, damage to the endothelial glycocalyx occurs. It is known from numerous studies that the integrity of the endothelial glycocalyx is necessary for organ function. Normothermic machine perfusion is an alternative storage method for explanted livers, where the graft is perfused with warm blood. This study aims to clarify the influence of normothermic machine perfusion on endothelial glycocalyx damage of the graft.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
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

入选标准

  • First deceased donor liver transplantation receiving a graft after normothermic machine perfusion
  • Recipient age >18 years
  • Written informed consent

排除标准

  • Age < 18 years

研究组 & 干预措施

Normothermic Machine Perfusion

Experimental

Blood sampling at 5 time points after transplantation Perfusate collection at 3 time points during normothermic machine perfusion prior to transplantation

干预措施: Heparansulfate and Syndecan 1 (Diagnostic Test)

结局指标

主要结局

Syndecan 1 level during normothermic machine perfusion

时间窗: 24 hours

Syndecan 1 level at the end of normothermic perfusion compared to the beginning of perfusion

Heparansulfate level during normothermic machine perfusion

时间窗: 24 hours

Heparansulfate level at the end of normothermic perfusion compared to the beginning of perfusion

次要结局

  • Syndecan 1 after transplantation(72 hours)
  • Heparansulfate level after transplantation(72 hours)

研究者

发起方
Medical University Innsbruck
申办方类型
Other
责任方
Sponsor

研究点 (2)

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