<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/NCT04502160</url>
  </required_header>
  <id_info>
    <org_study_id>19089JH-SS</org_study_id>
    <nct_id>NCT04502160</nct_id>
  </id_info>
  <brief_title>The Northern Ireland Haemodialysis Vascular Access Database</brief_title>
  <acronym>NIVAD</acronym>
  <official_title>The Northern Ireland Haemodialysis Vascular Access Database</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Belfast Health and Social Care Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Belfast Health and Social Care Trust</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is database designed to explore clinical outcomes related to vascular assess in the&#xD;
      population of Northern Ireland with CKD Stage 5 and End-stage Renal Failure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Vascular access is the conduit by which blood is transferred from the patient to the dialysis&#xD;
      machine and back to the patient during therapy. There are three types of vascular access:&#xD;
      Arteriovenous fistulas (AVF), Central venous catheters (CVC) and Arteriovenous grafts (AVG).&#xD;
&#xD;
      AVFs are associated with the best patient survival in individuals undergoing dialysis&#xD;
      therapy. However, Up 30-50% of AVFs thrombose or fail to mature sufficiently to support&#xD;
      dialysis.&#xD;
&#xD;
      The aim of this database is to further research in the area of AVF outcomes using routinely&#xD;
      collected clinical data..&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 15, 2020</start_date>
  <completion_date type="Anticipated">October 22, 2024</completion_date>
  <primary_completion_date type="Anticipated">October 22, 2024</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Rates of Arteriovenous Fistula Failure to Mature</measure>
    <time_frame>1 year</time_frame>
    <description>Rates of Arteriovenous Fistula Failure to Mature</description>
  </primary_outcome>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Hemodialysis Access Failure</condition>
  <condition>Arteriovenous Fistula</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Vascular Access Creation</intervention_name>
    <description>arteriovenous fistula creation</description>
    <other_name>arteriovenous fistula creation</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Individuals undergoing AVF creation between January 2009 and December 2020 in a single&#xD;
        centre (Belfast City Hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Individuals attending Nephrology undergoing AVFcreation between January 2009 and&#xD;
             December 2019 in a single centre (Belfast City Hospital&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>105 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Jennifer Hanko</last_name>
    <role>Principal Investigator</role>
    <affiliation>Belfast Health and Social Care Trust</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Agnes Masengu</last_name>
    <phone>0289043819</phone>
    <email>agnes.masengu@belfasttrust.hscni.net</email>
  </overall_contact>
  <location>
    <facility>
      <name>Belfast City Hospital</name>
      <address>
        <city>Belfast</city>
        <state>Antrim</state>
        <zip>BT9 7AB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Agnes Masengu</last_name>
      <email>agnes.masengu@belfasttrust.hscni.net</email>
    </contact>
    <contact_backup>
      <last_name>Jennifer Hanko</last_name>
      <email>jennifer.hanko@belfasttrust.hscni.net</email>
    </contact_backup>
    <investigator>
      <last_name>Agnes Masengu</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jennifer Hanko</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>August 4, 2020</study_first_submitted>
  <study_first_submitted_qc>August 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 6, 2020</study_first_posted>
  <last_update_submitted>April 14, 2022</last_update_submitted>
  <last_update_submitted_qc>April 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arteriovenous Fistula</mesh_term>
    <mesh_term>Fistula</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Would require application to Belfast Health and Social Care Trust Research and Development office</ipd_description>
  </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/NCT04502160
org study id: 19089JH-SS
nct id: NCT04502160
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is database designed to explore clinical outcomes related to vascular assess in the
      population of Northern Ireland with CKD Stage 5 and End-stage Renal Failure.
Vascular access is the conduit by which blood is transferred from the patient to the dialysis
      machine and back to the patient during therapy. There are three types of vascular access:
      Arteriovenous fistulas (AVF), Central venous catheters (CVC) and Arteriovenous grafts (AVG).

      AVFs are associated with the best patient survival in individuals undergoing dialysis
      therapy. However, Up 30-50% of AVFs thrombose or fail to mature sufficiently to support
      dialysis.

      The aim of this database is to further research in the area of AVF outcomes using routinely
      collected clinical data..
observational model: Cohort
time perspective: Retrospective
measure: Rates of Arteriovenous Fistula Failure to Mature
time frame: 1 year
description: Rates of Arteriovenous Fistula Failure to Mature
intervention type: Procedure
intervention name: Vascular Access Creation
description: arteriovenous fistula creation
other name: arteriovenous fistula creation
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 16 Years
maximum age: 105 Years
last name: Jennifer Hanko
role: Principal Investigator
affiliation: Belfast Health and Social Care Trust
last name: Agnes Masengu
phone: 0289043819
email: agnes.masengu@belfasttrust.hscni.net
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Arteriovenous Fistula
mesh term: Fistula
sharing ipd: No
ipd description: Would require application to Belfast Health and Social Care Trust Research and Development office