跳至主要内容
临床试验/NCT04446546
NCT04446546已完成不适用

Long Term Outcomes of Cold Stored Venous Allografts in Vascular Access for Hemodialysis

Central Hospital, Nancy, France1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2014年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
120
试验地点
1
主要终点
Intervention free vascular access survival (in days)

研究概览

简要总结

Vascular access creation in patients with renal failure requiring long-term hemodialysis can be a challenge when there is no more autologous material or in case of infection, in a population undergoing long term dialysis with a longer life-expectancy. Many types of grafts have been used, with its advantages and drawbacks, such as prosthetic grafts (PTFE). Over the past decade, surgeons have used cold stored venous allografts as a biological conduit for hemodialysis, with the idea of avoiding most of major complications including a lower incidence of infection and steal syndrome, with patencies at least equivalent to PTFE. There is only a few data in the litterature, but many surgical teams use it when there is no autologous material or in case of infection.

The aim of the study is to give the primary patency of vascular access with this technique, and to assess its long term outcomes.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

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

  • End stage renal failure patient requiring hemodialysis
  • With the placement of a venous allograft for a hemodialysis approach
  • Who underwent a surgery between January 1, 2014 and December 31, 2018 in a vascular surgery department participating in our study

排除标准

  • Patient <18 years old, or under guardianship / curatorship
  • Patient objecting to the use of his personal data in the context of research

结局指标

主要结局

Intervention free vascular access survival (in days)

时间窗: 3 years

The interval in days between the vascular access creation and the first successful re intervention (primary patency)

次要结局

  • Thrombosis free vascular access survival (in days)(3 years)
  • Abandonment of the vascular access (in days)(3 years)

研究者

发起方
Central Hospital, Nancy, France
申办方类型
Other
责任方
Sponsor

研究点 (1)

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