NCT05574361进行中（未招募）不适用
A Prospective Multi-Center Continued Access Protocol for the Use of the LifePort® Liver Transporter (LLT) System With Vasosol® in Orthotopic Liver Transplants (PILOT™_CA: Perfusion to Improve Liver Outcomes in Transplantation_ Continued Access Arm)
Organ Recovery Systems, Inc.7 个研究点 分布在 1 个国家目标入组 385 人开始时间: 2022年9月19日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 385
- 试验地点
- 7
- 主要终点
- Early Allograft Dysfunction (EAD)
研究概览
简要总结
To provide continued access for the LLT system to provide additional safety data in support of the PILOT pivotal efficacy and safety trial
详细描述
To provide continued access for the LLT System with Vasosol® for the preservation of whole explanted livers, thereby providing additional safety data in support of the PILOT pivotal efficacy and safety trial
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •≥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.
研究组 & 干预措施
Hypothermic Machine Perfusion
Experimental
Hypothermic Machine Perfusion with Organ Recovery Systems LifePort Liver Transporter system
干预措施: Hypothermic Machine Perfusion (Device)
结局指标
主要结局
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 (7)
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