Reduction of Ischemic-reperfusion Injury by Ex-vivo ATG-perfusion of Kidneys and Livers Prior Organ Transplantation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 主要终点
- Graft function
研究概览
简要总结
The increasing demand for organ transplantation and the shortage of available organs limit the success of organ transplantation programs. Consequently, acceptance of expanded criteria donor (ECD) organs with the consequences of higher risk of unfavorable transplantation outcome has become an increasing reality. Among the most prominent characteristics distinguishing ECD from Standard Criteria Donors (SCD) are risk factors including brain death (BD) or prolonged cold ischemia time (CI) amplifying ischemia reperfusion injury (IRI). Currently there are no standard regimens to improve the quality of ECD organs. Therefore, donor organ treatment might be a promising approach to substantially improve organ quality. It will be investigated whether the application of the peri-operative perfusion of kidneys and livers with the polyclonal antibody rabbit antithymocyte globulin (rATG) ameliorates IRI.
This trial is designed as a parallel armed randomized controlled trial.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients receiving a kidney or liver transplant from deceased donors
排除标准
- •Hepatitis C Virus/Human Immunodeficiency Virus, undergoing re-transplantation or under a public guardian
研究组 & 干预措施
AP-KTx/LTx
Transplant recipients receiving an rATG-perfused kidney or liver
干预措施: organ perfusion with rabbit anti-thymocyte globulin (rATG) (Biological)
CP-KTx/LTx
Transplant recipients receiving a control-perfused kidney or liver.
干预措施: organ perfusion with saline (Other)
结局指标
主要结局
Graft function
时间窗: Day 7
Graft function from baseline defined as serum creatinine (KTx arm) and aspartate transaminase (LTx arm).
次要结局
- Graft function - serum urea(Days 1-7 post transplantation, month 3, month 6, month 12)
- Graft function - aspartate transaminase(Days 1-7 post transplantation, month 3, month 6, month 12)
- Graft function - quick value(Days 1-7 post transplantation, month 3, month 6, month 12)
- BMI - recipient(Day zero, at the time point of transplantation)
- Graft function - creatinine(Days 1-7 post transplantation, month 3, month 6, month 12)
- Graft function - total serum bilirubin(Days 1-7 post transplantation, month 3, month 6, month 12)
- Graft function - alkaline phosphatase(Days 1-7 post transplantation, month 3, month 6, month 12)
- ICU stay(after transplantation)
- Graft function - glomeralur filtration rate(Days 1-7 post transplantation, month 3, month 6, month 12)
- Patient age - recipient(Day zero, at the time point of transplantation)
- BMI - donor(Day zero, at the time point of transplantation)
- Hospital stay(after transplantation)
- HLA missmatch(Day zero, at the time point of transplantation)
- Graft function - alanine transaminase(Days 1-7 post transplantation, month 3, month 6, month 12)
- Graft function - gamma-glutamyl transpeptidase(Days 1-7 post transplantation, month 3, month 6, month 12)
- Cold ischemia time(during transplantation)
- Panel-reactive antibodies(Day zero, at the time point of transplantation)
- Patient age - donor(Day zero, at the time point of transplantation)
- Sex - recipient(Day zero, at the time point of transplantation)
- Sex - donor(Day zero, at the time point of transplantation)
- Mortality(up to 12 month)
- Graft loss(up to 12 month)
- Warm ischemia time(during transplantation)
- Experimental analysis of perioperative taken biopsies(Peri-operatively (zero hour biopsy))
- Experimental analysis of peripheral blood monunuclear cells(prior transplantation, days 1-7 post transplantation, month 3, month 6, month 12 for lymphocyte expression analysis of peripheral blood)
- Delayed graft function(after transplantation)
研究者
Katja Kotsch
Univ. Prof. Dr. Katja Kotsch
Medical University Innsbruck