Trial to Evaluate the Safety and Effectiveness of the Portable Organ Care System (OCS™) Lung System for Recruiting, Preserving and Assessing Non-Ideal Donor Lungs for Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- TransMedics
- 入组人数
- 46
- 试验地点
- 28
- 主要终点
- Donor Lung Utilization Rate
研究概览
简要总结
To evaluate the safety and effectiveness of the OCS™ Lung System to recruit, preserve and assess non-ideal donor lungs that may not meet current standard donor lung acceptance criteria for transplantation.
详细描述
Inclusion
At least one of the following:
- Donor PaO2/FiO2 ≤ 300 mmHg at the time of the offer; or
- Expected cross-clamp time > 6 hours for the second lung; or
- Donor after Cardiac Death (DCD donor); or
- Donor age ≥ 55 years old
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female primary double lung transplant candidate
- •Age ≥ 18 years old
- •Signed: 1) written informed consent document and 2) authorization to use and disclose protected health information
排除标准
- •Prior solid organ or bone marrow transplant
- •Single lung recipient
- •Chronic use of hemodialysis or renal replacement therapy for diagnosis of chronic renal dysfunction requiring dialysis
- •Participant in any other clinical or investigational trials/programs
研究组 & 干预措施
OCS Preservation
干预措施: OCS Lung Preservation (Device)
结局指标
主要结局
Donor Lung Utilization Rate
时间窗: Immediately at Transplantation
Donor lung utilization rate, defined as the number of donated lungs instrumented on OCS™ that meet inclusion/exclusion criteria for the trial and acceptance criteria for transplantation after OCS™ Lung assessment divided by the total eligible donor lungs instrumented on the OCS™ Lung System.
Patient Survival
时间窗: 30 days post-transplantation or initial hospital discharge post-transplantation, a mean of 41.5 days post-transplant
Patient survival at Day-30 post-transplantation or initial hospital discharge post-transplantation, whichever occurs later.
次要结局
- Primary Graft Dysfunction Grade 3(72 hours post-transplant)