Ex-Vivo Lung Perfusion to Improve Donor Lung Function and Increase the Number of Organs Available for Transplantation
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Primary Graft Dysfunction 72 hours after lung transplantation (PGD72)
研究概览
简要总结
The recent introduction of ex-vivo lung perfusion (EVLP) as a tool to evaluate and recondition lungs from marginal donors has opened a new era in the field of lung transplantation.
详细描述
Aim of the investigation: to compare the clinical outcome after transplantation of subjects receiving marginal lungs procured from brain death donors and reconditioned by EVLP, with that of subjects receiving lungs procured from standard donors.
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
- Diagnostic
- 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
- •for donor lung:
- •Recipient to undergo single or bilateral Lung Transplantation
- •Donor arterial partial pressure of oxygen to fraction of inspired oxygen ratio (PaO2/FiO2) below 300 mmHg, or doubtful donor lung function
排除标准
- •for donor lung:
- •Massive lung contusion
结局指标
主要结局
Primary Graft Dysfunction 72 hours after lung transplantation (PGD72)
时间窗: 72 hours
Primary Graft Dysfunction 72 hours after transplantation (PGD72) definition: grade 3 according to the International Society of Heart and Lung Transplantation classification
30 day Mortality
时间窗: 30 days
次要结局
- ICU length of stay after transplantation(30 days)
- Duration of mechanical ventilation after transplantation(30 days)
研究者
Franco Valenza, MD
Assistant Professor Anaesthesia and Intensive Care, Department of Pathophysiology and Transplantation, Università degli Studi di Milano
Policlinico Hospital