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临床试验/NCT04616365
NCT04616365已完成不适用

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

University Health Network, Toronto3 个研究点 分布在 3 个国家目标入组 70 人开始时间: 2020年8月26日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
3
主要终点
Incidence of ISHLT Primary Graft Dysfunction Grade 3

研究概览

简要总结

In the current practice of lung transplantation, transplants are performed on a 24/7 schedule with a significant amount of procedures occurring overnight in order to minimize organ ischemic time. However, transplantation during the day time may lead to several advantages related to patient safety, including the presence of rested staff performing optimally, larger number of in-house professionals for emergency situations, and professional well-being. Advances and refinements in preservation practices have evolved to show that extended periods of preservation can be achieved without compromising outcome. Based on this, it is hypothesized that the avoidance of nighttime lung transplantation through prolonged pulmonary preservation will lead to at least similar patient outcomes compared to the current practice of 24/7 transplantation. During the period of this study, overnight transplants will be moved to a later start time (earliest 6AM). If lungs meet criteria for direct transplantation, they will be preserved with cold static preservation at 10°C within a special refrigerator. The maximum preservation time from donor cold flush to recipient anesthesia start time will be 12 hours.

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

入选标准

  • •Recipient inclusion criteria
  • •Primary lung transplantation
  • •Informed consent provided
  • •18-80 years old

排除标准

  • •Re-transplantation
  • •Multi-organ transplantation
  • •>80 years old
  • •Donor inclusion criteria
  • •Age ≤70 years old
  • •Donor lungs are suitable to go straight to lung transplantation
  • •Donor exclusion criteria
  • •Age >70 years old
  • •Concerns with organ preservation technique
  • •Donor lungs require assessment by Ex Vivo Lung Perfusion (EVLP)

研究组 & 干预措施

Semi-Elective Lung Transplantation

Experimental

Planned Semi-Elective Lung Transplantation Using 10°C Cold Static Preservation

干预措施: Semi-Elective Lung Transplantation (Procedure)

结局指标

主要结局

Incidence of ISHLT Primary Graft Dysfunction Grade 3

时间窗: 72 hours post-transplant

次要结局

  • Six minute walk test(1 year post-transplant)
  • ICU and hospital length of stay(Perioperative)
  • Occurrence of acute rejection(1 year post-transplant)
  • Overall survival(30 days, 1 year post-transplant)
  • Time on ventilator(Perioperative)
  • Forced expiratory volume - one second (FEV1 in L)(1 year post-transplant)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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