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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cold Stored Allograft Vascular Access |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| 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 |
| 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) |
| 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) |
Inclusion Criteria:
Exclusion Criteria:
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Hemodialysis patient with end-stage renal disease for whom a allograft was used for his hemodialysis access.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Departement of Vascular Surgery Nancy University Hospital | Nancy | Lorraine | 54000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29730128 | Background | 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. | |
| 7664014 |
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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 |
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 |
| Background |
| 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. |
| 14650287 | Background | 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. |
| 16490368 | Background | 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. |
| 22367646 | Background | 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. |