<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04402775</url>
  </required_header>
  <id_info>
    <org_study_id>NL54827.098.15</org_study_id>
    <nct_id>NCT04402775</nct_id>
  </id_info>
  <brief_title>Brachiocephalic Arteriovenous Fistulae: Two Different Techniques of Bloodless Surgery and Their Effect on Fistula Stenosis.</brief_title>
  <acronym>ABAS</acronym>
  <official_title>Brachiocephalic Arteriovenous Fistulae: Two Different Techniques of Bloodless Surgery and Their Effect on Fistula Stenosis.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>HagaZiekenhuis</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>HagaZiekenhuis</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients with a chronic kidney disease who opt for hemodialysis, needs a well-functioning&#xD;
      hemodialysis access. The autologous arteriovenous fistula (AVF) is recognized as the golden&#xD;
      standard of dialysis access. Unfortunately a great number of the AVFs fail to mature, and&#xD;
      therefore cannot be used for dialysis. A significant stenosis is a major cause of nonmaturing&#xD;
      AVFs. Remarkable are the stenoses that seem to develop in the venous outflow tract where the&#xD;
      vascular clamp was located during surgery. The primary aim of this study was to compare&#xD;
      bloodless surgery using vascular clamps and a tourniquet with respect to the development of&#xD;
      hemodynamic or anatomical significant stenosis in patients with a brachiocephalic or&#xD;
      radiocephalic AVF.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with a chronic kidney disease who opt for hemodialysis, needs a well-functioning&#xD;
      hemodialysis access. The autologous arteriovenous fistula (AVF) is the golden standard of&#xD;
      dialysis access. Unfortunately a great number of the AVFs fail to mature, and therefore&#xD;
      cannot be used for dialysis. A significant stenosis is a major cause of nonmaturing AVFs.&#xD;
&#xD;
      Remarkable are the stenoses that seem to develop in the venous outflow tract where the&#xD;
      vascular clamp was located during surgery. The primary aim of this study was to compare&#xD;
      bloodless surgery using vascular clamps and a tourniquet with respect to the development of&#xD;
      hemodynamic or anatomical significant stenosis in patients with a brachiocephalic or&#xD;
      radiocephalic AVF.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Due to a low inclusion rate&#xD;
  </why_stopped>
  <start_date>April 2016</start_date>
  <completion_date type="Actual">July 2018</completion_date>
  <primary_completion_date type="Actual">July 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Patients eligible for the trial were randomly allocated to the tourniquet group (intervention) or vascular clamp group (control)</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Stenosis postoperative (duplex ultrasonography)</measure>
    <time_frame>6 weeks</time_frame>
    <description>Luminal vessel diameter</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Duration of surgery</measure>
    <time_frame>During surgery</time_frame>
    <description>Duration of surgery in minutes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AVF occlusion</measure>
    <time_frame>Within 3 months after surgery</time_frame>
    <description>AVF occlusion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bleeding</measure>
    <time_frame>Within 3 months after surgery</time_frame>
    <description>Bleeding</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infection</measure>
    <time_frame>Within 3 months after surgery</time_frame>
    <description>Infection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pseudoaneurysm</measure>
    <time_frame>Within 3 months after surgery</time_frame>
    <description>Pseudoaneurysm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Need for reintervention</measure>
    <time_frame>1 year postoperative</time_frame>
    <description>Surgical or endovascular reintervention</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Arteriovenous Fistula</condition>
  <condition>Tourniquet</condition>
  <condition>Stenosis</condition>
  <arm_group>
    <arm_group_label>Vascular clamps</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients randomized to the use of vascular clamps to obtain a bloodless field during arteriovenous fistula surgery (standard protocol).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tourniquet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients randomized to the use of a tourniquet to obtain a bloodless field during arteriovenous fistula surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Tourniquet</intervention_name>
    <description>A tourniquet will be used during surgery</description>
    <arm_group_label>Tourniquet</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Mentally competent&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
          -  Age 18 years and older&#xD;
&#xD;
          -  Indication for brachiocephalic AVF in HagaZiekenhuis&#xD;
&#xD;
          -  Patient is able to complete the follow-up evaluation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <reference>
    <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.</citation>
    <PMID>18241764</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>9423717</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>16813989</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>16813991</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>11733628</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>18802208</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>12969170</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>19570886</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>15944600</PMID>
  </reference>
  <reference>
    <citation>Richtlijn Shuntchirurgie, Nederlandse Vereniging voor Heelkunde. Utrecht; 2010.</citation>
  </reference>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>April 16, 2016</study_first_submitted>
  <study_first_submitted_qc>May 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>May 24, 2020</last_update_submitted>
  <last_update_submitted_qc>May 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>HagaZiekenhuis</investigator_affiliation>
    <investigator_full_name>M.J.C. de Kok</investigator_full_name>
    <investigator_title>Medical student</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arteriovenous Fistula</mesh_term>
    <mesh_term>Constriction, Pathologic</mesh_term>
    <mesh_term>Fistula</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04402775
org study id: NL54827.098.15
nct id: NCT04402775
lead sponsor: 
has dmc: Yes
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Patients eligible for the trial were randomly allocated to the tourniquet group (intervention) or vascular clamp group (control)
primary purpose: Prevention
masking: Double (Participant, Outcomes Assessor)
measure: Stenosis postoperative (duplex ultrasonography)
time frame: 6 weeks
description: Luminal vessel diameter
measure: Duration of surgery
time frame: During surgery
description: Duration of surgery in minutes
measure: AVF occlusion
time frame: Within 3 months after surgery
description: AVF occlusion
measure: Bleeding
time frame: Within 3 months after surgery
description: Bleeding
measure: Infection
time frame: Within 3 months after surgery
description: Infection
measure: Pseudoaneurysm
time frame: Within 3 months after surgery
description: Pseudoaneurysm
measure: Need for reintervention
time frame: 1 year postoperative
description: Surgical or endovascular reintervention
arm group label: Vascular clamps
arm group type: No Intervention
description: Patients randomized to the use of vascular clamps to obtain a bloodless field during arteriovenous fistula surgery (standard protocol).
arm group label: Tourniquet
arm group type: Experimental
description: Patients randomized to the use of a tourniquet to obtain a bloodless field during arteriovenous fistula surgery.
intervention type: Other
intervention name: Tourniquet
description: A tourniquet will be used during surgery
arm group label: Tourniquet
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
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.
PMID: 18241764
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.
PMID: 9423717
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.
PMID: 16813989
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.
PMID: 16813991
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.
PMID: 11733628
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.
PMID: 18802208
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.
PMID: 12969170
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.
PMID: 19570886
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.
PMID: 15944600
citation: Richtlijn Shuntchirurgie, Nederlandse Vereniging voor Heelkunde. Utrecht; 2010.
responsible party type: Principal Investigator
investigator affiliation: HagaZiekenhuis
investigator full name: M.J.C. de Kok
investigator title: Medical student
mesh term: Arteriovenous Fistula
mesh term: Constriction, Pathologic
mesh term: Fistula
sharing ipd: Undecided