Prospective, International, Multi-Center, Randomized Clinical Investigation of TransMedics Organ Care System (OCS LUNG) for Lung Preservation and Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- TransMedics
- 入组人数
- 320
- 试验地点
- 21
- 主要终点
- A Composite of Patient Survival at Day 30 Post Transplantation, and Absence of International Society for Heart & Lung Transplantation (ISHLT) Primary Graft Dysfunction (PGD3) Grade 3 Within the First 72 Hours Post-transplantation.
研究概览
简要总结
A prospective, international, multi-center, randomized controlled trial comparing preservation of donor lungs using OCS-Lung perfusion device (Treatment Group) to cold flush and storage (Control Group).
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
- •Registered primary double-lung transplant candidate
- •Age > or equal to 18
- •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
- •Multiple organ transplant recipient
- •Chronic use of hemodialysis or diagnosis of chronic renal insufficiency
研究组 & 干预措施
OCS Lung (Treatment Group)
The OCS Lung, which is a portable, integrated platform designed to maintain adult donor lungs in a normothermic state through continuous normothermic perfusion and ventilation, will be used to preserve and transport donor lungs.
干预措施: OCS Lung (Device)
Cold flush and storage (Control Group)
Donor lungs will be preserved using cold flush and storage (control group)
干预措施: Cold flush and storage (Device)
结局指标
主要结局
A Composite of Patient Survival at Day 30 Post Transplantation, and Absence of International Society for Heart & Lung Transplantation (ISHLT) Primary Graft Dysfunction (PGD3) Grade 3 Within the First 72 Hours Post-transplantation.
时间窗: Day 30 after transplantation
This composite is a single outcome measure. Primary graft dysfunction is graded on a scale of 0 to 3 according to the 2005 ISHLT PGD grading consensus. Grade 0 is considered the least severe and grade 3 is considered a more severe outcome.
次要结局
- Patient Survival at Day 30(Day 30)
- Participants With International Society for Heart & Lung Transplantation (ISHLT) PGD Grade 3 at 72 Hours Post-transplantation(72 hours after transplantation)
- Participants With ISHLT PGD Grade 2 or 3 at 72 Hours Post-transplantation(72 hours after transplantation)