Results of Cold Stored Allografts in Vascular Access (RAVASC)

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

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.

Study Overview

• Status: Completed
• Conditions: Hemodialysis Access Failure; End Stage Renal Failure on Dialysis
• Intervention / Treatment: Procedure: Vascular access by pass using a cold stored venous allograft

• Study Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• France
  • Lorraine
    • Nancy, Lorraine, France, 54000
      • Departement of Vascular Surgery Nancy University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Hemodialysis patient with end-stage renal disease for whom a allograft was used for his hemodialysis access.

• The patient can be treated on an ambulatory surgery or in full hospitalization
• In the surgical departments having given their agreement to participate in our study

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cold Stored Allograft Vascular Access	Procedure: Vascular access by pass using a cold stored venous allograft; Creation or surgical repair of a vascular access for hemodialysis using a cold venous allograft

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Early and late complications (in days)	The interval in days between the vascular access creation and the occurence of complications (stenosis, thrombosis, failure, hyperflow, distal ischemia, aneurysm)	30 days
Early and late complications (in days)	The interval in days between the vascular access creation and the occurence of complications (stenosis, thrombosis, failure, hyperflow, distal ischemia, aneurysm)	90 days
Early and late complications (in days)	The interval in days between the vascular access creation and the occurence of complications (stenosis, thrombosis, failure, hyperflow, distal ischemia, aneurysm)	6 months
Early and late complications (in days)	The interval in days between the vascular access creation and the occurence of complications (stenosis, thrombosis, failure, hyperflow, distal ischemia, aneurysm)	1 year
Early and late complications (in days)	The interval in days between the vascular access creation and the occurence of complications (stenosis, thrombosis, failure, hyperflow, distal ischemia, aneurysm)	2 years
Early and late complications (in days)	The interval in days between the vascular access creation and the occurence of complications (stenosis, thrombosis, failure, hyperflow, distal ischemia, aneurysm)	3 years
Incidence of the socio-demographic and clinical characteristics of the patients on secondary patency	Compare the duration of secondary patency according to the socio-demographic and clinical characteristics of the patients	3 years

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France

Publications and helpful links

General Publications

• Schmidli J, Widmer MK, Basile C, de Donato G, Gallieni M, Gibbons CP, Haage P, Hamilton G, Hedin U, Kamper L, Lazarides MK, Lindsey B, Mestres G, Pegoraro M, Roy J, Setacci C, Shemesh D, Tordoir JHM, van Loon M, Esvs Guidelines Committee, Kolh P, de Borst GJ, Chakfe N, Debus S, Hinchliffe R, Kakkos S, Koncar I, Lindholt J, Naylor R, Vega de Ceniga M, Vermassen F, Verzini F, Esvs Guidelines Reviewers, Mohaupt M, Ricco JB, Roca-Tey R. Editor's Choice - Vascular Access: 2018 Clinical Practice Guidelines of the European Society for Vascular Surgery (ESVS). Eur J Vasc Endovasc Surg. 2018 Jun;55(6):757-818. doi: 10.1016/j.ejvs.2018.02.001. Epub 2018 May 2. No abstract available.
• Heintjes RJ, Eikelboom BC, Steijling JJ, van Reedt Dortland RW, van der Heijden FH, Bastini M, van der Graaf Y, Blankestijn PJ, Vos J. The results of denatured homologous vein grafts as conduits for secondary haemodialysis access surgery. Eur J Vasc Endovasc Surg. 1995 Jan;9(1):58-63. doi: 10.1016/s1078-5884(05)80226-6.
• Schneider M, Barrou B, Cluzel P, Hamani A, Bitker MO, Richard F. [Value of preserved saphenous vein graft for the creation of access ports in hemodialyzed patients: report of 309 cases]. Prog Urol. 2003 Sep;13(4):585-91. French.
• Berardinelli L. Grafts and graft materials as vascular substitutes for haemodialysis access construction. Eur J Vasc Endovasc Surg. 2006 Aug;32(2):203-11. doi: 10.1016/j.ejvs.2006.01.001. Epub 2006 Feb 20.
• Nedved K, Suchy T, Halova J, Malicky M, Gorun P, Vitvar P. Allogenous vein graft as vascular access for hemodialysis--lost battle? J Vasc Access. 2012 Jul-Sep;13(3):366-73. doi: 10.5301/jva.5000062.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2014
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): May 30, 2020

Study Registration Dates

• First Submitted: June 16, 2020
• First Submitted That Met QC Criteria: June 23, 2020
• First Posted (Actual): June 25, 2020

Study Record Updates

• Last Update Posted (Actual): June 25, 2020
• Last Update Submitted That Met QC Criteria: June 23, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Hemodialysis; Complication; Vascular access; Haemodialysis; Patency; Saphenous vein; Homologous vein; Allogenous vein graft; Cold stored venous allograft; Biological graft; Primary patency; Secondary patency
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic
• Other Study ID Numbers: 2020PI096

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No