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临床试验/NCT03007017
NCT03007017已完成不适用

Novel Strategies for Innovating Deceased Donor Procurement

University of Maryland, Baltimore2 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2017年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
2
试验地点
2
主要终点
Sequence of organ procurement

研究概览

简要总结

Despite many efforts to increase the size of the donor pool, there is a large and growing disparity between the number of donor kidneys available for transplantation and the number of patients on the transplant waiting list. Increasing the quality of currently available donor kidneys would potentially improve the longevity of deceased donor kidney transplants by years, thus increasing the rate of transplantation patients on the kidney transplant waiting list. In addition, recipients of higher quality kidneys have shorter hospital stays and lower total hospital charges. By innovating the organ donation process, such that deceased donor kidneys are removed prior to the cessation of cardiac activity, rather than after, it may be possible to improve the quality of the kidney before transplantation, resulting in improved function after transplantation and increased longevity of these transplanted kidneys. Further, this improved kidney quality is highly likely to translate to reduced need for renal dialysis and other high-cost interventions, yielding lower total hospital charges. In this study we will test the hypothesis that, through a cost-free technical innovation, the quality of deceased donor kidneys could be improved significantly, saving thousands more lives per year and reducing total health care expenditures on renal transplantation.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
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

  • Currently listed to receive a deceased donor kidney transplant
  • Able to fully understand the informed consent document
  • Recipient over the age of 18 years

排除标准

  • Recipients undergoing a bilateral native nephrectomy at time of transplant
  • Recipients undergoing dual (liver-kidney, kidney-pancreas, pediatric en bloc) transplant
  • Individuals who are unable to understand the informed consent document
  • Recipient under age 18 years
  • Recipients receiving desensitization protocols for high levels of donor specific antibodies

结局指标

主要结局

Sequence of organ procurement

时间窗: 1 year

Renal allograft survival

Kidney quality

时间窗: 3 months

Incidence of delayed renal graft function

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Joseph Scalea

Assistant Professor of Surgery Director of Pancreas and Islet Cell Transplantation

University of Maryland, Baltimore

研究点 (2)

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