Arteriovenous FistulaABASNCT04402775
Brachiocephalic Arteriovenous Fistulae: Two Different Techniques of Bloodless Surgery and Their Effect on Fistula Stenosis.
A study testing Tourniquet in people with Arteriovenous Fistula and Tourniquet, run by HagaZiekenhuis.
Trial summary
Patients with a chronic kidney disease who opt for hemodialysis, needs a well-functioning hemodialysis access. The autologous arteriovenous fistula (AVF) is recognized as the golden standard of dialysis access. Unfortunately a great number of the AVFs fail to mature, and therefore cannot be used for dialysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arteriovenous Fistula, Tourniquet, Stenosis
- What is being tested?
- Tourniquet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Apr 2016to Jul 2018
- Phase
- Interventional
- 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
Who may be able to join
- Mentally competent
- Written informed consent
- Age 18 years and older
- Indication for brachiocephalic AVF in HagaZiekenhuis
- Patient is able to complete the follow-up evaluation
Who cannot join
- Pregnancy
About this study
Patients with a chronic kidney disease who opt for hemodialysis, needs a well-functioning hemodialysis access. The autologous arteriovenous fistula (AVF) is recognized as the golden standard of dialysis access. Unfortunately a great number of the AVFs fail to mature, and therefore cannot be used for dialysis. A significant stenosis is a major cause of nonmaturing AVFs. Remarkable are the stenoses that seem to develop in the venous outflow tract where the vascular clamp was located during surgery. The primary aim of this study was to compare bloodless surgery using vascular clamps and a tourniquet with respect to the development of hemodynamic or anatomical significant stenosis in patients with a brachiocephalic or radiocephalic AVF.
Read the detailed description
Patients with a chronic kidney disease who opt for hemodialysis, needs a well-functioning hemodialysis access. The autologous arteriovenous fistula (AVF) is the golden standard of dialysis access. Unfortunately a great number of the AVFs fail to mature, and therefore cannot be used for dialysis. A significant stenosis is a major cause of nonmaturing AVFs.
Remarkable are the stenoses that seem to develop in the venous outflow tract where the vascular clamp was located during surgery. The primary aim of this study was to compare bloodless surgery using vascular clamps and a tourniquet with respect to the development of hemodynamic or anatomical significant stenosis in patients with a brachiocephalic or radiocephalic AVF.
- Conditions
- Arteriovenous Fistula, Tourniquet, Stenosis
- Being tested
- Tourniquet
- Medical subject headings
- Arteriovenous Fistula, Constriction, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TourniquetOther
A tourniquet will be used during surgery
| Study group | Role | What they receive |
|---|---|---|
| Vascular clamps | No intervention | Patients randomized to the use of vascular clamps to obtain a bloodless field during arteriovenous fistula surgery (standard protocol). |
| Tourniquet | Experimental | Patients randomized to the use of a tourniquet to obtain a bloodless field during arteriovenous fistula surgery. Receives: Other: Tourniquet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stenosis postoperative (duplex ultrasonography)
Luminal vessel diameter
Measured: 6 weeks
Secondary outcomes (6)
Duration of surgery
Duration of surgery in minutes
Measured: During surgery
AVF occlusion
AVF occlusion
Measured: Within 3 months after surgery
Bleeding
Bleeding
Measured: Within 3 months after surgery
Infection
Infection
Measured: Within 3 months after surgery
Pseudoaneurysm
Pseudoaneurysm
Measured: Within 3 months after surgery
Need for reintervention
Surgical or endovascular reintervention
Measured: 1 year postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2020
- Study startApr 2016
- Primary completionJul 2018
- Study completionJul 2018
Why it stopped: Due to a low inclusion rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Arteriovenous FistulaStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients eligible for the trial were randomly allocated to the tourniquet group (intervention) or vascular clamp group (control)
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- HagaZiekenhuis
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, M.J.C. de Kok, HagaZiekenhuis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04402775
- Sponsor's protocol ID
- NL54827.098.15
- Acronym
- ABAS
- Status last verified
- May 2020
- First submitted
- 16 Apr 2016
- Last updated
- 27 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Biuckians A, Scott EC, Meier GH, Panneton JM, Glickman MH. The natural history of autologous fistulas as first-time dialysis access in the KDOQI era. J Vasc Surg. 2008 Feb;47(2):415-21; discussion 420-1. doi: 10.1016/j.jvs.2007.10.041.
PubMed 18241764Hodges TC, Fillinger MF, Zwolak RM, Walsh DB, Bech F, Cronenwett JL. Longitudinal comparison of dialysis access methods: risk factors for failure. J Vasc Surg. 1997 Dec;26(6):1009-19. doi: 10.1016/s0741-5214(97)70014-4.
PubMed 9423717Vascular Access 2006 Work Group. Clinical practice guidelines for vascular access. Am J Kidney Dis. 2006 Jul;48 Suppl 1:S176-247. doi: 10.1053/j.ajkd.2006.04.029. No abstract available.
PubMed 16813989Vascular Access Work Group. Clinical practice guidelines for vascular access. Am J Kidney Dis. 2006 Jul;48 Suppl 1:S248-73. doi: 10.1053/j.ajkd.2006.04.040. No abstract available.
PubMed 16813991Turmel-Rodrigues L, Mouton A, Birmele B, Billaux L, Ammar N, Grezard O, Hauss S, Pengloan J. Salvage of immature forearm fistulas for haemodialysis by interventional radiology. Nephrol Dial Transplant. 2001 Dec;16(12):2365-71. doi: 10.1093/ndt/16.12.2365.
PubMed 11733628Duijm LE, Overbosch EH, Liem YS, Planken RN, Tordoir JH, Cuypers PW, Douwes-Draaijer P, de Haan MW. Retrograde catheterization of haemodialysis fistulae and grafts: angiographic depiction of the entire vascular access tree and stenosis treatment. Nephrol Dial Transplant. 2009 Feb;24(2):539-47. doi: 10.1093/ndt/gfn526. Epub 2008 Sep 18.
PubMed 18802208Beathard GA, Arnold P, Jackson J, Litchfield T; Physician Operators Forum of RMS Lifeline. Aggressive treatment of early fistula failure. Kidney Int. 2003 Oct;64(4):1487-94. doi: 10.1046/j.1523-1755.2003.00210.x.
PubMed 12969170Turmel-Rodrigues L, Boutin JM, Camiade C, Brillet G, Fodil-Cherif M, Mouton A. Percutaneous dilation of the radial artery in nonmaturing autogenous radial-cephalic fistulas for haemodialysis. Nephrol Dial Transplant. 2009 Dec;24(12):3782-8. doi: 10.1093/ndt/gfp324. Epub 2009 Jul 1.
PubMed 19570886Grogan J, Castilla M, Lozanski L, Griffin A, Loth F, Bassiouny H. Frequency of critical stenosis in primary arteriovenous fistulae before hemodialysis access: should duplex ultrasound surveillance be the standard of care? J Vasc Surg. 2005 Jun;41(6):1000-6. doi: 10.1016/j.jvs.2005.02.019.
PubMed 15944600Richtlijn Shuntchirurgie, Nederlandse Vereniging voor Heelkunde. Utrecht; 2010.
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brachiocephalic Arteriovenous Fistulae: Two Different Techniques of Bloodless Surgery and Their Effect on Fistula Stenosis.
- ClinicalTrials.gov ID
- NCT04402775
- Acronym / sponsor ID
- ABAS / NL54827.098.15
- Conditions
- Arteriovenous Fistula, Tourniquet, Stenosis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to a low inclusion rate
- Enrolment
- 25 participants (actual)
- Lead sponsor
- HagaZiekenhuisUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Jul 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 27 May 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.
Patients with a chronic kidney disease who opt for hemodialysis, needs a well-functioning hemodialysis access. The autologous arteriovenous fistula (AVF) is recognized as the golden standard of dialysis access. Unfortunately a great number of the AVFs fail to mature, and therefore cannot be used for dialysis. A significant stenosis is a major cause of nonmaturing AVFs. Remarkable are the stenoses that seem to develop in the venous outflow tract where the vascular clamp was located during surgery. The primary aim of this study was to compare bloodless surgery using vascular clamps and a tourniquet with respect to the development of hemodynamic or anatomical significant stenosis in patients with a brachiocephalic or radiocephalic AVF.
Detailed description
Patients with a chronic kidney disease who opt for hemodialysis, needs a well-functioning hemodialysis access. The autologous arteriovenous fistula (AVF) is the golden standard of dialysis access. Unfortunately a great number of the AVFs fail to mature, and therefore cannot be used for dialysis. A significant stenosis is a major cause of nonmaturing AVFs.
Remarkable are the stenoses that seem to develop in the venous outflow tract where the vascular clamp was located during surgery. The primary aim of this study was to compare bloodless surgery using vascular clamps and a tourniquet with respect to the development of hemodynamic or anatomical significant stenosis in patients with a brachiocephalic or radiocephalic AVF.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients eligible for the trial were randomly allocated to the tourniquet group (intervention) or vascular clamp group (control)
| Arm | Type | Receives |
|---|---|---|
| Vascular clamps | No intervention | –Patients randomized to the use of vascular clamps to obtain a bloodless field during arteriovenous fistula surgery (standard protocol). |
| Tourniquet | Experimental | Other: TourniquetPatients randomized to the use of a tourniquet to obtain a bloodless field during arteriovenous fistula surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Mentally competent
- Written informed consent
- Age 18 years and older
- Indication for brachiocephalic AVF in HagaZiekenhuis
- Patient is able to complete the follow-up evaluation
Key exclusion criteria (1 listed)
- Pregnancy
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 |
|---|---|---|
| TourniquetA tourniquet will be used during surgery | Other | Tourniquet |
Primary outcome
Stenosis postoperative (duplex ultrasonography)
Time frame: 6 weeks
Luminal vessel diameter
6 secondary outcomes
Duration of surgery
Time frame: During surgery
AVF occlusion
Time frame: Within 3 months after surgery
Bleeding
Time frame: Within 3 months after surgery
Infection
Time frame: Within 3 months after surgery
Pseudoaneurysm
Time frame: Within 3 months after surgery
Need for reintervention
Time frame: 1 year postoperative
Results and safety
The study was stopped early (reason given: Due to a low inclusion rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2020.
- Background: PubMed 18241764Biuckians A, Scott EC, Meier GH, Panneton JM, Glickman MH. The natural history of autologous fistulas as first-time dialysis access in the KDOQI era. J Vasc Surg. 2008 Feb;47(2):415-21; discussion 420-1. doi: 10.1016/j.jvs.2007.10.041.
- Background: PubMed 9423717Hodges TC, Fillinger MF, Zwolak RM, Walsh DB, Bech F, Cronenwett JL. Longitudinal comparison of dialysis access methods: risk factors for failure. J Vasc Surg. 1997 Dec;26(6):1009-19. doi: 10.1016/s0741-5214(97)70014-4.
- Background: PubMed 16813989Vascular Access 2006 Work Group. Clinical practice guidelines for vascular access. Am J Kidney Dis. 2006 Jul;48 Suppl 1:S176-247. doi: 10.1053/j.ajkd.2006.04.029. No abstract available.
- Background: PubMed 16813991Vascular Access Work Group. Clinical practice guidelines for vascular access. Am J Kidney Dis. 2006 Jul;48 Suppl 1:S248-73. doi: 10.1053/j.ajkd.2006.04.040. No abstract available.
- Background: PubMed 11733628Turmel-Rodrigues L, Mouton A, Birmele B, Billaux L, Ammar N, Grezard O, Hauss S, Pengloan J. Salvage of immature forearm fistulas for haemodialysis by interventional radiology. Nephrol Dial Transplant. 2001 Dec;16(12):2365-71. doi: 10.1093/ndt/16.12.2365.
- Background: PubMed 18802208Duijm LE, Overbosch EH, Liem YS, Planken RN, Tordoir JH, Cuypers PW, Douwes-Draaijer P, de Haan MW. Retrograde catheterization of haemodialysis fistulae and grafts: angiographic depiction of the entire vascular access tree and stenosis treatment. Nephrol Dial Transplant. 2009 Feb;24(2):539-47. doi: 10.1093/ndt/gfn526. Epub 2008 Sep 18.
- Background: PubMed 12969170Beathard GA, Arnold P, Jackson J, Litchfield T; Physician Operators Forum of RMS Lifeline. Aggressive treatment of early fistula failure. Kidney Int. 2003 Oct;64(4):1487-94. doi: 10.1046/j.1523-1755.2003.00210.x.
- Background: PubMed 19570886Turmel-Rodrigues L, Boutin JM, Camiade C, Brillet G, Fodil-Cherif M, Mouton A. Percutaneous dilation of the radial artery in nonmaturing autogenous radial-cephalic fistulas for haemodialysis. Nephrol Dial Transplant. 2009 Dec;24(12):3782-8. doi: 10.1093/ndt/gfp324. Epub 2009 Jul 1.
- Background: PubMed 15944600Grogan J, Castilla M, Lozanski L, Griffin A, Loth F, Bassiouny H. Frequency of critical stenosis in primary arteriovenous fistulae before hemodialysis access: should duplex ultrasound surveillance be the standard of care? J Vasc Surg. 2005 Jun;41(6):1000-6. doi: 10.1016/j.jvs.2005.02.019.
- BackgroundRichtlijn Shuntchirurgie, Nederlandse Vereniging voor Heelkunde. Utrecht; 2010.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Tourniquet in people with Arteriovenous Fistula and Tourniquet, run by HagaZiekenhuis.
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 5 inclusion and 1 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: stopped early, as of the sponsor's last update on 27 May 2020. Status can change between updates, so confirm with the study contact before making plans.
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 was stopped early (reason given: Due to a low inclusion rate). Results are not available in the source record.
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?
Stenosis postoperative (duplex ultrasonography) (time frame: 6 weeks). 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 NCT04402775, which also lists 10 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 27 May 2020; AzTrials last refreshed its copy on 8 Nov 2026.