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
干预措施
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
研究组 & 干预措施
Delayed Lung Transplantation
Experimental
Patients that received lung(s) delayed for transplantation
干预措施: Delayed Lung Transplantation (Procedure)
Conventional Lung Transplantation
Active Comparator
Reference Therapy
干预措施: Conventional Lung Transplantation (Procedure)
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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