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

Primary Purpose

Arteriovenous Fistula, Tourniquet, Stenosis

Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Tourniquet
Sponsored by
HagaZiekenhuis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Arteriovenous Fistula

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

  • Pregnancy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Vascular clamps

    Tourniquet

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Stenosis postoperative (duplex ultrasonography)
    Luminal vessel diameter

    Secondary Outcome Measures

    Duration of surgery
    Duration of surgery in minutes
    AVF occlusion
    AVF occlusion
    Bleeding
    Bleeding
    Infection
    Infection
    Pseudoaneurysm
    Pseudoaneurysm
    Need for reintervention
    Surgical or endovascular reintervention

    Full Information

    First Posted
    April 16, 2016
    Last Updated
    May 24, 2020
    Sponsor
    HagaZiekenhuis
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04402775
    Brief Title
    Brachiocephalic Arteriovenous Fistulae: Two Different Techniques of Bloodless Surgery and Their Effect on Fistula Stenosis.
    Acronym
    ABAS
    Official Title
    Brachiocephalic Arteriovenous Fistulae: Two Different Techniques of Bloodless Surgery and Their Effect on Fistula Stenosis.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2020
    Overall Recruitment Status
    Terminated
    Why Stopped
    Due to a low inclusion rate
    Study Start Date
    April 2016 (undefined)
    Primary Completion Date
    July 2018 (Actual)
    Study Completion Date
    July 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    HagaZiekenhuis

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Arteriovenous Fistula, Tourniquet, Stenosis

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Patients eligible for the trial were randomly allocated to the tourniquet group (intervention) or vascular clamp group (control)
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    25 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Vascular clamps
    Arm Type
    No Intervention
    Arm Description
    Patients randomized to the use of vascular clamps to obtain a bloodless field during arteriovenous fistula surgery (standard protocol).
    Arm Title
    Tourniquet
    Arm Type
    Experimental
    Arm Description
    Patients randomized to the use of a tourniquet to obtain a bloodless field during arteriovenous fistula surgery.
    Intervention Type
    Other
    Intervention Name(s)
    Tourniquet
    Intervention Description
    A tourniquet will be used during surgery
    Primary Outcome Measure Information:
    Title
    Stenosis postoperative (duplex ultrasonography)
    Description
    Luminal vessel diameter
    Time Frame
    6 weeks
    Secondary Outcome Measure Information:
    Title
    Duration of surgery
    Description
    Duration of surgery in minutes
    Time Frame
    During surgery
    Title
    AVF occlusion
    Description
    AVF occlusion
    Time Frame
    Within 3 months after surgery
    Title
    Bleeding
    Description
    Bleeding
    Time Frame
    Within 3 months after surgery
    Title
    Infection
    Description
    Infection
    Time Frame
    Within 3 months after surgery
    Title
    Pseudoaneurysm
    Description
    Pseudoaneurysm
    Time Frame
    Within 3 months after surgery
    Title
    Need for reintervention
    Description
    Surgical or endovascular reintervention
    Time Frame
    1 year postoperative

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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: Pregnancy

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    18241764
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    9423717
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    16813989
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    16813991
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    11733628
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    18802208
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    12969170
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    19570886
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    15944600
    Citation
    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.
    Results Reference
    background
    Citation
    Richtlijn Shuntchirurgie, Nederlandse Vereniging voor Heelkunde. Utrecht; 2010.
    Results Reference
    background

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

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