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Completed

NCT Number: NCT04446546

Results of Cold Stored Allografts in Vascular Access

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.

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Key information

Conditions

End Stage Renal Failure on Dialysis Hemodialysis Access Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Departement of Vascular Surgery Nancy University Hospital

Nancy, Lorraine, 54000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vascular access by pass using a cold stored venous allograft

Procedure

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

Primary outcomes

  1. Intervention free vascular access survival (in days)

    Time frame: 30 days

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

  2. Intervention free vascular access survival (in days)

    Time frame: 6 months

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

  3. Intervention free vascular access survival (in days)

    Time frame: 1 year

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

  4. Intervention free vascular access survival (in days)

    Time frame: 2 years

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

  5. 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

  1. Thrombosis free vascular access survival (in days)

    Time frame: 30 days

    The interval in days between the vascular access creation and the first occlusion with a successful re intervention (primary assisted pantency)

  2. Thrombosis free vascular access survival (in days)

    Time frame: 90 days

    The interval in days between the vascular access creation and the first occlusion with a successful re intervention (primary assisted pantency)

  3. Thrombosis free vascular access survival (in days)

    Time frame: 6 months

    The interval in days between the vascular access creation and the first occlusion with a successful re intervention (primary assisted pantency)

  4. Thrombosis free vascular access survival (in days)

    Time frame: 1 year

    The interval in days between the vascular access creation and the first occlusion with a successful re intervention (primary assisted pantency)

  5. Thrombosis free vascular access survival (in days)

    Time frame: 2 years

    The interval in days between the vascular access creation and the first occlusion with a successful re intervention (primary assisted pantency)

  6. Thrombosis free vascular access survival (in days)

    Time frame: 3 years

    The interval in days between the vascular access creation and the first occlusion with a successful re intervention (primary assisted pantency)

  7. Abandonment of the vascular access (in days)

    Time frame: 30 days

    The interval in days between the vascular access creation and its abandonment (secondary patency)

  8. Abandonment of the vascular access (in days)

    Time frame: 90 days

    The interval in days between the vascular access creation and its abandonment (secondary patency)

  9. Abandonment of the vascular access (in days)

    Time frame: 6 months

    The interval in days between the vascular access creation and its abandonment (secondary patency)

  10. Abandonment of the vascular access (in days)

    Time frame: 1 year

    The interval in days between the vascular access creation and its abandonment (secondary patency)

  11. Abandonment of the vascular access (in days)

    Time frame: 2 years

    The interval in days between the vascular access creation and its abandonment (secondary patency)

  12. Abandonment of the vascular access (in days)

    Time frame: 3 years

    The interval in days between the vascular access creation and its abandonment (secondary patency)

Other outcomes

  1. Early and late complications (in days)

    Time frame: 30 days

    The interval in days between the vascular access creation and the occurence of complications (stenosis, thrombosis, failure, hyperflow, distal ischemia, aneurysm)

  2. Early and late complications (in days)

    Time frame: 90 days

    The interval in days between the vascular access creation and the occurence of complications (stenosis, thrombosis, failure, hyperflow, distal ischemia, aneurysm)

  3. Early and late complications (in days)

    Time frame: 6 months

    The interval in days between the vascular access creation and the occurence of complications (stenosis, thrombosis, failure, hyperflow, distal ischemia, aneurysm)

  4. Early and late complications (in days)

    Time frame: 1 year

    The interval in days between the vascular access creation and the occurence of complications (stenosis, thrombosis, failure, hyperflow, distal ischemia, aneurysm)

  5. Early and late complications (in days)

    Time frame: 2 years

    The interval in days between the vascular access creation and the occurence of complications (stenosis, thrombosis, failure, hyperflow, distal ischemia, aneurysm)

  6. Early and late complications (in days)

    Time frame: 3 years

    The interval in days between the vascular access creation and the occurence of complications (stenosis, thrombosis, failure, hyperflow, distal ischemia, aneurysm)

  7. Incidence of the socio-demographic and clinical characteristics of the patients on secondary patency

    Time frame: 3 years

    Compare the duration of secondary patency according to the socio-demographic and clinical characteristics of the patients

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

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

Acronym: RAVASC

Important dates

Study start
2014
Primary completion
2018
Study completion
2020
First posted
Jun 25, 2020
Registry last updated
Jun 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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