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Clinical Trials/NCT04446546
NCT04446546
Completed
Not Applicable

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

Central Hospital, Nancy, France1 site in 1 country120 target enrollmentJanuary 1, 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
End Stage Renal Failure on Dialysis
Sponsor
Central Hospital, Nancy, France
Enrollment
120
Locations
1
Primary Endpoint
Intervention free vascular access survival (in days)
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2014
End Date
May 30, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Central Hospital, Nancy, France
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Intervention free vascular access survival (in days)

Time Frame: 3 years

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

Secondary Outcomes

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

Study Sites (1)

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