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临床试验/NCT04601818
NCT04601818已完成不适用

Planned Semi-Elective Lung Transplantation Using 10C Cold Static Preservation: A Proof-Of-Concept Study

University of Florida1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2020年11月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
45
试验地点
1
主要终点
Incidence of ISHLT Primary Graft Dysfunction Grade 3 at 72 hours (expected rate less than 20%)

研究概览

简要总结

When suitable donor lungs become available for a consented recipient, and the donor cross clamp time occurs between 6pm and 4am, the transplant procedure (anesthesia starting time) will be allowed to be moved to a 6am start or later with the lungs being preserved at 10C cold static preservation upon organ arrival to our hospital using a specific refrigerator. The maximum allowed time between donor cross clamp and recipient anesthesia initiation will be 12h.

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 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Primary lung transplantation
  • Informed consent provided
  • Donor Inclusion: Age<70

排除标准

  • Re-transplantation
  • Multi-organ transplantation
  • Donor exclusion criteria:
  • Age >70y
  • Concerns with organ preservation technique

结局指标

主要结局

Incidence of ISHLT Primary Graft Dysfunction Grade 3 at 72 hours (expected rate less than 20%)

时间窗: 72 hours post op

次要结局

  • 1-year survival(procedure up to 1 year post op)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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