Clinical trial NCT04446546: Results of Cold Stored Allografts in Vascular Access
Official title: Long Term Outcomes of Cold Stored Venous Allografts in Vascular Access for Hemodialysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2020-06-25
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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

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.


Eligibility criteria: 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

Primary outcomes:
measure: Intervention free vascular access survival (in days)
timeFrame: 30 days
measure: Intervention free vascular access survival (in days)
timeFrame: 6 months
measure: Intervention free vascular access survival (in days)
timeFrame: 1 year
measure: Intervention free vascular access survival (in days)
timeFrame: 2 years
measure: Intervention free vascular access survival (in days)
timeFrame: 3 years
Secondary outcomes:
measure: Thrombosis free vascular access survival (in days)
timeFrame: 30 days
measure: Thrombosis free vascular access survival (in days)
timeFrame: 90 days
measure: Thrombosis free vascular access survival (in days)
timeFrame: 6 months
measure: Thrombosis free vascular access survival (in days)
timeFrame: 1 year
measure: Thrombosis free vascular access survival (in days)
timeFrame: 2 years
measure: Thrombosis free vascular access survival (in days)
timeFrame: 3 years
measure: Abandonment of the vascular access (in days)
timeFrame: 30 days
measure: Abandonment of the vascular access (in days)
timeFrame: 90 days
measure: Abandonment of the vascular access (in days)
timeFrame: 6 months
measure: Abandonment of the vascular access (in days)
timeFrame: 1 year
measure: Abandonment of the vascular access (in days)
timeFrame: 2 years
measure: Abandonment of the vascular access (in days)
timeFrame: 3 years
Other outcomes:
measure: Early and late complications (in days)
timeFrame: 30 days
measure: Early and late complications (in days)
timeFrame: 90 days
measure: Early and late complications (in days)
timeFrame: 6 months
measure: Early and late complications (in days)
timeFrame: 1 year
measure: Early and late complications (in days)
timeFrame: 2 years
measure: Early and late complications (in days)
timeFrame: 3 years
measure: Incidence of the socio-demographic and clinical characteristics of the patients on secondary patency
timeFrame: 3 years
Locations:
city: Nancy
country: France
facility: Departement of Vascular Surgery Nancy University Hospital
state: Lorraine
Study officials:
References:
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. No abstract available.
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. doi: 10.1016/s1078-5884(05)80226-6.
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.
citation: 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.
citation: 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.