NCT04568694已完成不适用
Planned Semi-Elective Lung Transplantation Using 10C Cold Static Preservation: A Proof-of-Concept Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Incidence of ISHLT primary graft dysfunction grade 3 at 72 hours post-transplant
研究概览
简要总结
This is a prospective, single-arm study to demonstrate the proof-of-concept of semi-elective lung transplantation. We plan to evaluate 15 patients that receive lung(s) delayed for transplantation under our study criteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Recipient is ≥ 18 years old
- •Recipient, or their Legally Authorized Representative is able and willing to sign informed consent
- •Recipient meets standard listing criteria for lung transplantation
排除标准
- •Donor lungs meet criteria for transplantation with ex vivo lung perfusion (EVLP)
- •Recipient is < 18 years old
- •Recipient, or their Legally Authorized Representative is unable to sign informed consent for re-transplantation
- •Recipient has any condition that, in the opinion of the Investigator, would make study participation unsafe or would interfere with the objectives of the study
结局指标
主要结局
Incidence of ISHLT primary graft dysfunction grade 3 at 72 hours post-transplant
时间窗: 72 hours
As defined by International Society of Heart and Lung Transplantation (ISHLT)
次要结局
未报告次要终点
研究者
研究点 (1)
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