NCT03484455已完成不适用
A Prospective Randomized Multi-Center Study of the Use of the Organ Recovery Systems LifePort® Liver Transporter (LLT) System With Vasosol® as Compared to Static Cold Storage in Orthotopic Liver Transplants (Perfusion to Improve Liver Outcomes in Transplantation)
Organ Recovery Systems, Inc.17 个研究点 分布在 1 个国家目标入组 142 人开始时间: 2019年4月3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
- 142
- 试验地点
- 17
- 主要终点
- Number of patients in each arm with Early Allograft Dysfunction (EAD)
研究概览
简要总结
Comparison of hypothermic machine perfusion of livers to standard of care (static cold storage).
详细描述
Prospective, randomized, multi-center study to show safe and effective use of whole liver preservation via hypothermic machine perfusion (HMP) as compared to livers preserved by static cold storage.
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 (Outcomes Assessor)
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
- •≥18 years of age
- •Active on the United Network for Organ Sharing (UNOS) waiting list for liver transplantation
- •De novo liver transplant recipient
- •Written informed consent required
排除标准
- •Subject is a multi-organ transplant recipient
- •Subject is antibodies blood group (ABO) liver incompatible
- •Subject has severe systemic infection
- •Subject is Human Immunodeficiency Virus (HIV) positive
- •Subject has acute/fulminant liver failure
- •Subject is pregnant
结局指标
主要结局
Number of patients in each arm with Early Allograft Dysfunction (EAD)
时间窗: 7 days
EAD defined as total bilirubin ≥ 10 mg/dL or International Normalized Ratio (INR) ≥ 1.6 or Aspartate Aminotransferase (AST) \>2000IU/L or Alanine Aminotransferase (ALT) \> 2000 IU/L
次要结局
未报告次要终点
研究者
研究点 (17)
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