Results of Cold Stored Allografts in Vascular Access

Study Overview
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Brief Summary
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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.

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

Conditions
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End Stage Renal Failure on Dialysis, Hemodialysis Access Failure

Intervention / Treatment
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* Procedure: Vascular access by pass using a cold stored venous allograft


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cold Stored Allograft Vascular Access<br> | Procedure: Vascular access by pass using a cold stored venous allograft<br>* Creation or surgical repair of a vascular access for hemodialysis using a cold venous allograft<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intervention free vascular access survival (in days) | The interval in days between the vascular access creation and the first successful re intervention (primary patency) | 30 days | 
| Intervention free vascular access survival (in days) | The interval in days between the vascular access creation and the first successful re intervention (primary patency) | 6 months | 
| Intervention free vascular access survival (in days) | The interval in days between the vascular access creation and the first successful re intervention (primary patency) | 1 year | 
| Intervention free vascular access survival (in days) | The interval in days between the vascular access creation and the first successful re intervention (primary patency) | 2 years | 
| Intervention free vascular access survival (in days) | The interval in days between the vascular access creation and the first successful re intervention (primary patency) | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thrombosis free vascular access survival (in days) | The interval in days between the vascular access creation and the first occlusion with a successful re intervention (primary assisted pantency) | 30 days | 
| Thrombosis free vascular access survival (in days) | The interval in days between the vascular access creation and the first occlusion with a successful re intervention (primary assisted pantency) | 90 days | 
| Thrombosis free vascular access survival (in days) | The interval in days between the vascular access creation and the first occlusion with a successful re intervention (primary assisted pantency) | 6 months | 
| Thrombosis free vascular access survival (in days) | The interval in days between the vascular access creation and the first occlusion with a successful re intervention (primary assisted pantency) | 1 year | 
| Thrombosis free vascular access survival (in days) | The interval in days between the vascular access creation and the first occlusion with a successful re intervention (primary assisted pantency) | 2 years | 
| Thrombosis free vascular access survival (in days) | The interval in days between the vascular access creation and the first occlusion with a successful re intervention (primary assisted pantency) | 3 years | 
| Abandonment of the vascular access (in days) | The interval in days between the vascular access creation and its abandonment (secondary patency) | 30 days | 
| Abandonment of the vascular access (in days) | The interval in days between the vascular access creation and its abandonment (secondary patency) | 90 days | 
| Abandonment of the vascular access (in days) | The interval in days between the vascular access creation and its abandonment (secondary patency) | 6 months | 
| Abandonment of the vascular access (in days) | The interval in days between the vascular access creation and its abandonment (secondary patency) | 1 year | 
| Abandonment of the vascular access (in days) | The interval in days between the vascular access creation and its abandonment (secondary patency) | 2 years | 
| Abandonment of the vascular access (in days) | The interval in days between the vascular access creation and its abandonment (secondary patency) | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemodialysis, Vascular access, Homologous vein, Allogenous vein graft, Cold stored venous allograft, Saphenous vein, Haemodialysis, Biological graft, Patency, Primary patency, Secondary patency, Complication