Results of Cold Stored Allografts in Vascular Access

Completed

• Conditions: End Stage Renal Failure on Dialysis; Hemodialysis Access Failure
• Interventions: Procedure: Vascular access by pass using a cold stored venous allograft

• Registration Number: NCT04446546
• Lead Sponsor: Central Hospital, Nancy, France

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-01
• Primary Completion: 2018-12-31
• Study Completion: 2020-05-30
• Status Verified: 2020-06
• Study First Submitted: 2020-06-16
• Study First Submitted QC: 2020-06-23
• Last Update Submitted: 2020-06-23
• Study First Posted: 2020-06-25
• Last Update Posted: 2020-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cold Stored Allograft Vascular Access	Vascular access by pass using a cold stored venous allograft	-

Primary Outcome Measures

Name	Time	Method
Intervention free vascular access survival (in days)	3 years	The interval in days between the vascular access creation and the first successful re intervention (primary patency)

Secondary Outcome Measures

Name	Time	Method
Thrombosis free vascular access survival (in days)	3 years	The interval in days between the vascular access creation and the first occlusion with a successful re intervention (primary assisted pantency)
Abandonment of the vascular access (in days)	3 years	The interval in days between the vascular access creation and its abandonment (secondary patency)

Trial Locations

Locations (1)

Departement of Vascular Surgery Nancy University Hospital; 🇫🇷 Nancy, Lorraine, France