NCT02449694已完成不适用
Single-arm Prospective Trial to Evaluate The Safety and Performance of The Portable Organ Care System (OCS™) Liver For Preserving and Assessing Donor Livers for Transplantation
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- TransMedics
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Number of donor livers preserved by OCS in a near physiologic state.
研究概览
简要总结
A prospective, single-center controlled trial to evaluate the safety and performance of the portable Organ Care System (OCS) Liver for preservation and assessment of donor livers for transplantation.
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
- •Registered male or female primary Liver transplant candidate
- •Age ≥18 years old
- •Signed: written informed consent
排除标准
- •Acute, fulminant liver failure;
- •Prior solid organ or bone marrow transplant;
- •Chronic use of hemodialysis or diagnosis of chronic renal failure, defined as chronic serum creatinine of >3 mg/dl (>265 mmol/L) for >2 weeks and/or requiring hemodialysis;
- •Multi-organ transplant;
- •Ventilator dependent;
- •Dependent on > 1 IV inotrope to maintain hemodynamics;
- •Malignancy excluding HCC;
- •Infection.
研究组 & 干预措施
OCS Liver
Experimental
OCS Liver will be used to preserve the donor liver
干预措施: OCS Liver (Device)
结局指标
主要结局
Number of donor livers preserved by OCS in a near physiologic state.
时间窗: Within 1 day of organ retrieval
Number of events directly related to the use of the OCS Liver that led to the donor liver being deemed not clinically acceptable and, as a result, not transplanted
时间窗: Within 1 day of organ retrieval
次要结局
- Number of donor livers monitored for perfusate temperatures, SvO2, hematocrit, Hepatic Artery flow rates, Portal Vein flow rate, Hepatic Artery pressure, Portal vein pressure, and bile production during preservation.(Within 1 day of organ retrieval)
- Number of donor livers maintained in a metabolically active and functioning state during preservation.(Within 1 day of organ retrieval)
- Frequency of liver graft-related serious adverse events(30 days after transplantation)
研究者
研究点 (2)
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