NCT02775162已完成不适用
A Multicenter Randomized Controlled Trial to Compare the Efficacy of Ex-vivo Normothermic Machine Perfusion With Static Cold Storage in Human Liver Transplantation
OrganOx Ltd.30 个研究点 分布在 1 个国家目标入组 267 人开始时间: 2016年10月9日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 267
- 试验地点
- 30
- 主要终点
- Percentage of Participants With Early Allograft Dysfunction (EAD)
研究概览
简要总结
A multicenter randomized controlled trial to compare the efficacy of ex-vivo normothermic machine profusion with static cold storage in human liver 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is 18 years of age or greater
- •Subject is registered as an active recipient on the United Network for Organ Sharing (UNOS) waiting list for liver transplantation
- •Subject, or legally authorized representative, is able and willing to give informed consent and HIPAA authorization
- •Subject is able and willing to comply with all study requirements
排除标准
- •Subject requiring all of the following at the time of transplantation: oxygen therapy, inotropic support, renal replacement therapy
- •Subject has acute/fulminant liver failure
- •Subject undergoing simultaneous transplantation of more than one organ
- •Subject is pregnant or nursing
- •Concurrent enrollment in another clinical trial. Subjects enrolled in clinical trials or registries where only measurements and/or samples are taken (NO TEST DEVICE or TEST DRUG USED) are allowed to participate.
结局指标
主要结局
Percentage of Participants With Early Allograft Dysfunction (EAD)
时间窗: 7 Days
EAD is a binary outcome defined by the presence of one of the following 3 outcomes: * Serum bilirubin ≥ 10 mg/dL at day 7 post-transplant * International normalized ratio (INR) ≥ 1.6 at day 7 post-transplant * Alanine Aminotransferase (ALT) or Aspartate Transaminase (AST) \> 2000 IU/L within the first 7 days post-transplant
次要结局
- Number of Participants With Primary Non-Function(10 Days)
- Number of Participants With Graft Survival(6 Months)
- Number of Participants With Subject Survival(6 Months)
- Number of Participants With Post-Reperfusion Syndrome(1 Day)
- Measure Biochemical Liver Function Via Bilirubin(6 Months)
- Measure Biochemical Liver Function Via Alanine Aminotransferase (ALT)(6 Months)
- Measure Biochemical Liver Function Via Aspartate Transaminase (AST)(6 Months)
- Measure Biochemical Liver Function Via Alkaline Phosphatase (ALP)(6 Months)
- Measure Biochemical Liver Function Via International Normalized Ratio (INR)(6 Months)
- Measure Biochemical Liver Function Via Lactate(Days 1-7)
- Number of Participants With Evidence of Ischemia-Reperfusion Injury Via Comparison of Pre-Reperfusion Biopsies to Post-Reperfusion Biopsies(1 Day)
- Measure Biochemical Liver Function Via Gamma-Glutamyl Transferase (GGT)(6 Months)
- Number of Participants With Biliary Investigations and Biliary Interventions(6 Months)
- Number of Livers Randomized But Not Transplanted(1 Day)
- Number of Livers That Did Not Experience a Safety Event(10 Days)
- Assessment of the Health Economic Implications Via Length of ICU Stay and Length of Hospital Stay(6 Months)
- Compare Quality of Life Via the EQ-5D-5L Quality of Life Questionnaire(6 Months)
研究者
研究点 (30)
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