Pilot Study of Lung Transplantation After Ex-Vivo Lung Reconditioning
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Hopital Foch
- 入组人数
- 45
- 试验地点
- 4
- 主要终点
- number of "transplantable" grafts and Reduced waiting time before transplantation
研究概览
简要总结
Only about 15% of the potential candidates for lung donation are considered suitable for transplantation. Thus, a strategy that could improve the quality and precision of assessment of nonacceptable donor lungs could have a major impact on reducing waiting time and mortality while on the list.
A new method for ex vivo lung perfusion (EVLP) has been developed recently by Steen and colleagues to assess the quality of lungs from a non-heart-beating donor. The method can also be used to recondition "marginal" and nonacceptable donor lungs.
After harvesting, the lungs were perfused ex vivo with Steen Solution, an extracellular matrix with high colloid osmotic pressure. A membrane oxygenator connected to the circuit received gas from a mixture of nitrogen and carbon dioxide, maintaining a normal mixed venous blood gas level in the perfusate. The lungs were gradually rewarmed, reperfused, and ventilated for evaluation through analyses of oxygenation capacity, pulmonary vascular resistance (PVR), lung compliance (LC), and biopsy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Patients on the waiting list for lung transplantation and for which the Biomedicine -Agency has awarded a lung transplantation after Ex-Vivo lung reconditioning
- •Patients affiliated to a social security system;
- •Patients who consented to participate in writing
排除标准
- •Patients under tutorship or unable to consent or institutionalized
结局指标
主要结局
number of "transplantable" grafts and Reduced waiting time before transplantation
时间窗: 12 months
次要结局
- Difference of data obtained 2 hours after Ex-Vivo lung reconditioning with those obtained 4 hours after Ex-Vivo lung reconditioning(4 hours after Ex-Vivo lung reconditioning)
- Number of deaths of patients on waiting list(5 years)
- survival time after lung transplantation with ExVivo lung reconditioning(1 year after end of study)
- Quality of life scale score after lung transplantation with ExVivo lung reconditioning(1 year after end of study)
