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临床试验/NCT02906436
NCT02906436已完成不适用

Pilot Study of Lung Transplantation After Ex-Vivo Lung Reconditioning

Hopital Foch4 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2011年2月最近更新:
适应症

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

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)

研究者

发起方
Hopital Foch
申办方类型
Other
责任方
Sponsor

研究点 (4)

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