Results of Cold Stored Allografts in Vascular Access

End Stage Renal Failure on Dialysis Clinical Trial

— RAVASC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04446546
• Other study ID #: 2020PI096
• Status: Completed
• Start date: January 1, 2014
• Est. completion date: May 30, 2020

Study information

• Verified date: June 2020
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: May 30, 2020
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• End Stage Renal Failure on Dialysis
• Hemodialysis Access Failure
• Kidney Failure, Chronic

Intervention

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

Locations

Country	Name	City	State
France	Departement of Vascular Surgery Nancy University Hospital	Nancy	Lorraine

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

References & Publications (5)

Berardinelli L. Grafts and graft materials as vascular substitutes for haemodialysis access construction. Eur J Vasc Endovasc Surg. 2006 Aug;32(2):203-11. Epub 2006 Feb 20. Review. — View Citation

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. — View Citation

Nedved K, Suchý T, Hálová J, Malický 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Abandonment of the vascular access (in days)	The interval in days between the vascular access creation and its abandonment (secondary patency)	30 days
Secondary	Abandonment of the vascular access (in days)	The interval in days between the vascular access creation and its abandonment (secondary patency)	90 days
Secondary	Abandonment of the vascular access (in days)	The interval in days between the vascular access creation and its abandonment (secondary patency)	6 months
Secondary	Abandonment of the vascular access (in days)	The interval in days between the vascular access creation and its abandonment (secondary patency)	1 year
Secondary	Abandonment of the vascular access (in days)	The interval in days between the vascular access creation and its abandonment (secondary patency)	2 years
Secondary	Abandonment of the vascular access (in days)	The interval in days between the vascular access creation and its abandonment (secondary patency)	3 years