Evaluation of Tacrolimus (Prograf®) Intraportal Infusion During the Implantation and the Protective Effect on Ischemia-reperfusion Injury in Orthotopic Liver Transplant Recipients - Single Center Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- initial liver function measured by the parameters of the liver function (LFP): AST (U/L), ALT (U/L), total Bilirubin (mg/dL) and the coagulation factors: NT (%), PTT(s),INR.
研究概览
简要总结
The evaluation of the efficacy of an intraportal infusion with Tacrolimus, at the time of liver graft implantation, compared to a control group without immunosuppressive intraportal infusion (Placebo: Saline solution 0.9%) with respect to the initial liver function measured by the parameters of the liver function (LFP): AST (U/L), ALT (U/L), total Bilirubin (mg/dL) and the coagulation factors: NT (%), PTT (s), INR.
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
- Double (Participant, Investigator)
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
- •Multi organ transplantation or retransplantation
- •ABO incompatible donor organ recipients- Patients, who are listed on the liver transplant-waiting list at the Vienna General Hospital and who fulfill the clinical requirements (local allocation)
- •Written informed consent
- •Age > 18
- •First transplantation
排除标准
- •Fulminant failure of the liver
- •Liver-Living donor recipients
- •pregnant or nursing women
- •Allergy/Intolerance to antimetabolites, HCO-60, EL Cremophor or similar compounds,Steroids or macrolide antibiotics
- •HIV-positive donors or recipients
- •Participants of another clinical study
- •Patient has any form of substance abuse, psychiatric disorder or condition, which, in the opinion of the investigator, may invalidate communication.
研究组 & 干预措施
A
Group A receives an intraportal Tacrolimus-infusion, ATG Induction, Tacrolimus and Steroids.
干预措施: Tacrolimus (Drug)
B
Group B receives a placebo-Saline solution (0.9%)-Infusion, ATG induction, Tacrolimus and Steroids.
干预措施: Saline solution 0.9% (250mL) (Other)
结局指标
主要结局
initial liver function measured by the parameters of the liver function (LFP): AST (U/L), ALT (U/L), total Bilirubin (mg/dL) and the coagulation factors: NT (%), PTT(s),INR.
时间窗: Day 1,2,3; Weeks 6 and 12 post OLT
次要结局
- Serum parameters: TNF alpha, IL1, IL6(within the first 3 month)
- Histopathology (before and after reperfusion)(within the first 3 month)
- Frequency of rejection episodes(within the first 3 month)
- Graft function (Serum) und graft survival at 3 months post Tx(within the first 3 month)
- Patient survival at 3 months post Tx(within the first 3 month)