End Stage Renal Failure on DialysisRAVASCNCT04446546
Results of Cold Stored Allografts in Vascular Access
An observational study of End Stage Renal Failure on Dialysis and Hemodialysis Access Failure, run by Central Hospital, Nancy, France at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Failure on Dialysis, Hemodialysis Access Failure
- What is being tested?
- Vascular access by pass using a cold stored venous allograft
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2014to 30 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Patient <18 years old, or under guardianship / curatorship
- Patient objecting to the use of his personal data in the context of research
Trial locations and contacts
1 site in 1 country.
France1 site
Departement of Vascular Surgery Nancy University Hospital
Nancy, Lorraine, 54000
About this study
Official title: 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.
- Being tested
- Vascular access by pass using a cold stored venous allograft
- Keywords
- Hemodialysis, Vascular access, Homologous vein, Allogenous vein graft, Cold stored venous allograft, Saphenous vein, Haemodialysis, Biological graft, Patency, Primary patency, Secondary patency, Complication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vascular access by pass using a cold stored venous allograftProcedure or surgery
Creation or surgical repair of a vascular access for hemodialysis using a cold venous allograft
| Study group | Role | What they receive |
|---|---|---|
| Cold Stored Allograft Vascular Access | Not described Receives: Procedure: Vascular access by pass using a cold stored venous allograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention free vascular access survival (in days)
The interval in days between the vascular access creation and the first successful re intervention (primary patency)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 3 years
Secondary outcomes (12)
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 3 years
Abandonment of the vascular access (in days)
The interval in days between the vascular access creation and its abandonment (secondary patency)
Measured: 30 days
Abandonment of the vascular access (in days)
The interval in days between the vascular access creation and its abandonment (secondary patency)
Measured: 90 days
Abandonment of the vascular access (in days)
The interval in days between the vascular access creation and its abandonment (secondary patency)
Measured: 6 months
Abandonment of the vascular access (in days)
The interval in days between the vascular access creation and its abandonment (secondary patency)
Measured: 1 year
Abandonment of the vascular access (in days)
The interval in days between the vascular access creation and its abandonment (secondary patency)
Measured: 2 years
Abandonment of the vascular access (in days)
The interval in days between the vascular access creation and its abandonment (secondary patency)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2020
- Study start1 Jan 2014
- Primary completion31 Dec 2018
- Study completion30 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal Failure on DialysisStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04446546
- Sponsor's protocol ID
- 2020PI096
- Acronym
- RAVASC
- Status last verified
- Jun 2020
- First submitted
- 16 Jun 2020
- Last updated
- 25 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 29730128Heintjes 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.
PubMed 7664014Schneider 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.
PubMed 14650287Berardinelli 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.
PubMed 16490368Nedved 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.
PubMed 22367646
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Outcomes of Cold Stored Venous Allografts in Vascular Access for Hemodialysis
- ClinicalTrials.gov ID
- NCT04446546
- Acronym / sponsor ID
- RAVASC / 2020PI096
- Keywords
- Hemodialysis, Vascular access, Homologous vein, Allogenous vein graft, Cold stored venous allograft, Saphenous vein, Haemodialysis, Biological graft
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 30 May 2020 (actual)
- First posted
- 25 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cold Stored Allograft Vascular Access | – | Procedure: Vascular access by pass using a cold stored venous allograft |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Patient <18 years old, or under guardianship / curatorship
- Patient objecting to the use of his personal data in the context of research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vascular access by pass using a cold stored venous allograftCreation or surgical repair of a vascular access for hemodialysis using a cold venous allograft | Procedure or surgery | Cold Stored Allograft Vascular Access |
Primary outcome
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)
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)
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)
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)
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)
12 secondary outcomes
Thrombosis free vascular access survival (in days)
Time frame: 30 days
Thrombosis free vascular access survival (in days)
Time frame: 90 days
Thrombosis free vascular access survival (in days)
Time frame: 6 months
Thrombosis free vascular access survival (in days)
Time frame: 1 year
Thrombosis free vascular access survival (in days)
Time frame: 2 years
Thrombosis free vascular access survival (in days)
Time frame: 3 years
Abandonment of the vascular access (in days)
Time frame: 30 days
Abandonment of the vascular access (in days)
Time frame: 90 days
Abandonment of the vascular access (in days)
Time frame: 6 months
Abandonment of the vascular access (in days)
Time frame: 1 year
Abandonment of the vascular access (in days)
Time frame: 2 years
Abandonment of the vascular access (in days)
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2020.
- Background: PubMed 29730128Schmidli 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.
- Background: PubMed 7664014Heintjes 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.
- Background: PubMed 14650287Schneider 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.
- Background: PubMed 16490368Berardinelli 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.
- Background: PubMed 22367646Nedved 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of End Stage Renal Failure on Dialysis and Hemodialysis Access Failure, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention free vascular access survival (in days) (time frame: 30 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04446546, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2020.