ClinicalTrials.gg
TerminatedNCT04402775ABASUpdated May 27, 2020

Brachiocephalic Arteriovenous Fistulae: Two Different Techniques of Bloodless Surgery and Their Effect on Fistula Stenosis.

An interventional study of Tourniquet in Arteriovenous Fistula, Tourniquet and Stenosis, sponsored by HagaZiekenhuis. Terminated. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-05-27.

Sponsored by HagaZiekenhuis · Not applicable, Interventional, and Prevention

Why this study was terminated
Due to a low inclusion rate
Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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. 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.

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Conditions studied

  • Arteriovenous Fistula
  • Tourniquet
  • Stenosis
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In context

Arteriovenous Fistula

269 studies on the registry are indexed under Arteriovenous Fistula; 44 are open to participants now.

This study's enrollment of 25 is below the median of 68 across 179 interventional studies indexed under Arteriovenous Fistula.

Browse Arteriovenous Fistula studies →

Lead sponsor

HagaZiekenhuis is the lead sponsor of 5 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Pregnancy
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
25 participants (actual)

Study arms

  • No intervention
    Vascular clamps

    Patients randomized to the use of vascular clamps to obtain a bloodless field during arteriovenous fistula surgery (standard protocol).

  • Experimental
    Tourniquet

    Patients randomized to the use of a tourniquet to obtain a bloodless field during arteriovenous fistula surgery.

    Other: Tourniquet

Interventions

  • OtherTourniquet

    A tourniquet will be used during surgery

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What researchers measure

Primary outcomes

  1. Stenosis postoperative (duplex ultrasonography)

    Luminal vessel diameter

    Time frame: 6 weeks

Secondary outcomes

  1. Duration of surgery

    Duration of surgery in minutes

    Time frame: During surgery

  2. AVF occlusion

    AVF occlusion

    Time frame: Within 3 months after surgery

  3. Bleeding

    Bleeding

    Time frame: Within 3 months after surgery

  4. Infection

    Infection

    Time frame: Within 3 months after surgery

  5. Pseudoaneurysm

    Pseudoaneurysm

    Time frame: Within 3 months after surgery

  6. Need for reintervention

    Surgical or endovascular reintervention

    Time frame: 1 year postoperative

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Study locations

No study locations are listed for this record.

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References and documents

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 18241764 ↗
  • Hodges 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 9423717 ↗
  • Vascular 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 16813989 ↗
  • Vascular 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 16813991 ↗
  • Turmel-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 11733628 ↗
  • Duijm 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 18802208 ↗
  • Beathard 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 12969170 ↗
  • Turmel-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 19570886 ↗
  • Grogan 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 15944600 ↗
  • Richtlijn Shuntchirurgie, Nederlandse Vereniging voor Heelkunde. Utrecht; 2010.

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 27, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04402775
Lead sponsor
HagaZiekenhuis
Responsible party
M.J.C. de Kok (Medical student, HagaZiekenhuis) — Principal investigator
First posted
May 27, 2020
Start date
Apr 2016
Primary completion
Jul 2018
Completion
Jul 2018
Last update
May 27, 2020

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in May 2020. You cannot join it, but the record below documents what was studied.

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