TOP-Study (Tacrolimus Organ Perfusion): A Prospective Multicenter Trial for Treatment of Ischemia Reperfusion Injury in Marginal Organs With an ex Vivo Tacrolimus Perfusion
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 25
- 试验地点
- 7
- 主要终点
- Maximum serum ALT-level
研究概览
简要总结
Utilisation of extended criteria donors due to critical organ shortage contributes to increased ischemia reperfusion injury as well as mortality following liver transplantation. Experimental data show protective effects on hepatic ischemia reperfusion injury (IRI) using the calcineurin inhibitor Tacrolimus applied intravenously or directly as a hepatic rinse. Moreover clinical data indicate a protective role of a Tacrolimus rinse in human liver transplantation when using normal, healthy grafts. The effects of Tacrolimus on hepatic injury in extended donor criteria (EDC) liver grafts remain unclear. Therefore, the aim of the present study is to examine the effects of a Tacrolimus ex vivo rinse (20 ng/ml) on cellular injury after transplantation of marginal liver grafts exhibiting 2 or more EDCs according to Eurotransplant's definition of EDC grafts.
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
- Single (Participant)
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
- •Chronical terminal liver failure, age > 18 years, first organ transplantation
- •donor age > 65 Jahre
- •macrovesicular steatosis > 40% (macroscopy or biopsy)
- •BMI > 30
- •sodium >165 mmol/l
- •ICU stay and ventilation > 7 days
- •cold ischemia time > 13 hours
- •AST > 99 U/l
- •ALT > 105 U/l
- •bilirubin > 3 mg/dl (> 51 µmol/l)
- •application of epinephrine
排除标准
- •Hepatitis B- or Hepatitis C-infection
- •Multi organ transplantation
- •high urgency listing
- •extrahepatic tumor disease
- •pregnancy
研究组 & 干预措施
Tacrolimus + HTK
Ex vivo Tacrolimus Rinse (20 ng/ml solved in 1000 ml HTK) of marginal liver grafts prior to implantation
干预措施: Tacrolimus (Drug)
HTK
Ex vivo Rinse (1000 ml HTK) of marginal liver grafts prior to implantation
干预措施: HTK/Placebo (Drug)
结局指标
主要结局
Maximum serum ALT-level
时间窗: 48 hrs following liver transplantation
次要结局
- Bilirubin(1,2,4,7 days after surgery)
- ALT(1,2,4,7 days after surgery)
- AST(1,2,4,7 days after surgery)
- Creatinin(1,2,4,7 days after surgery)
- Graft survival(7 days)
研究者
Prof. Dr. M. Angele
Prof. Dr. med. Martin Angele
Ludwig-Maximilians - University of Munich