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Results of Cold Stored Allografts in Vascular Access

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04446546
Acronym
RAVASC
Enrollment
120
Registered
2020-06-25
Start date
2014-01-01
Completion date
2020-05-30
Last updated
2020-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End Stage Renal Failure on Dialysis, Hemodialysis Access Failure

Keywords

Hemodialysis, Vascular access, Homologous vein, Allogenous vein graft, Cold stored venous allograft, Saphenous vein, Haemodialysis, Biological graft, Patency, Primary patency, Secondary patency, Complication

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.

Interventions

PROCEDUREVascular access by pass using a cold stored venous allograft

Creation or surgical repair of a vascular access for hemodialysis using a cold venous allograft

Sponsors

Central Hospital, Nancy, France
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Intervention free vascular access survival (in days)30 daysThe interval in days between the vascular access creation and the first successful re intervention (primary patency)

Secondary

MeasureTime frameDescription
Thrombosis free vascular access survival (in days)30 daysThe 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)30 daysThe interval in days between the vascular access creation and its abandonment (secondary patency)

Other

MeasureTime frameDescription
Early and late complications (in days)30 daysThe interval in days between the vascular access creation and the occurence of complications (stenosis, thrombosis, failure, hyperflow, distal ischemia, aneurysm)
Incidence of the socio-demographic and clinical characteristics of the patients on secondary patency3 yearsCompare the duration of secondary patency according to the socio-demographic and clinical characteristics of the patients

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026