NCT02061462Unknown1 期
Extracorporeal Lung Perfusion and Ventilation to Evaluate the Eligibility for Transplantation of Lungs Retrieved From Donors After Cardio-circulatory Death (DCD)
Policlinico Hospital2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2014年10月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- 30 Day Mortality and Graft Survival
研究概览
简要总结
The procurement of organs from donors after cardiocirculatory death (DCD) is an accepted strategy to increase organ supply.
详细描述
Aim of the investigation: to compare the clinical outcome after transplantation of subjects receiving lungs procured from donors after cardiocirculatory death reconditioned and assessed by EVLP, with that of subjects receiving lungs procured from brain death donors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Lung donors:
- •subjects with brain death according to neurological or cardiocirculatory criteria
- •age below 65 yrs
- •absence of massive lung contusion, aspiration, pneumonia, sepsis
- •absence of infection, malignancy
- •Recipients:
- •subjects to undergo single or bilateral lung transplantation
- •informed consent to participate in the study
排除标准
- 未提供
结局指标
主要结局
30 Day Mortality and Graft Survival
时间窗: 30 days
30 day mortality and graft survival is used as a standard research measure to evaluate post transplant outcome
次要结局
- Duration of mechanical ventilation after transplantation(30 days)
- ICU length of stay after transplantation(30 days)
- Primary Graft Dysfunction 72 hours After Transplantation(72 hours)
研究者
Franco Valenza, MD
Assistant Professor Anaesthesia and Intensive Care, Department of Pathophysilogy and Transplantation, Università degli Studi di Milano
Policlinico Hospital
研究点 (2)
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