<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/NCT01685710</url>
  </required_header>
  <id_info>
    <org_study_id>RRK4178</org_study_id>
    <nct_id>NCT01685710</nct_id>
  </id_info>
  <brief_title>The Use of Glyceryl Trinitrate Patches in Arteriovenous Fistulas</brief_title>
  <official_title>The Use of Glyceryl Trinitrate Patches in Arteriovenous Fistulas</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital Birmingham</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital Birmingham</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study is to determine whether the application of a glyceryl trinitrate patch&#xD;
      (GTN patch) helps arteriovenous fistulas, created for renal dialysis access, mature so that&#xD;
      they can be used.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with end stage renal failure on haemodialysis must have a mechanism for achieving&#xD;
      access to their vascular system for dialysis. Arteriovenous fistulas (surgically created&#xD;
      connections between the artery and vein) are critical for the majority of patients. Not all&#xD;
      the fistulas that are created work, a proportion fail early on and need to be revised or an&#xD;
      alternative fistula created. A recent multicentre study demonstrated a 40% primary failure&#xD;
      rate(1). In an attempt to increase the numbers of fistulae that reach maturation sufficient&#xD;
      for dialysis access cannulation some renal centres apply GTN patches to the fistula at the&#xD;
      time of surgery. It is thought that this works by increasing the size of the blood vessels&#xD;
      and promoting blood flow through them and some preliminary work seems to support this(2).&#xD;
&#xD;
      The evidence for the use of GTN patches in arteriovenous fistula creation is theoretical or&#xD;
      based on preliminary work rather than robust evidence. Similarly no evidence exists within&#xD;
      the literature to determine the safety and definite efficacy of this procedure in this&#xD;
      population. We propose to conduct a double-blinded randomised control trial to answer the&#xD;
      study question: does the application of a GTN patch increase the venous outflow diameter post&#xD;
      fistula formation and does this result in improved fistula patency.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2013</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">May 2015</primary_completion_date>
  <phase>Phase 4</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change to diameter of vein</measure>
    <time_frame>Initial assessment and 6 weeks after surgery</time_frame>
    <description>At initial assessment of the vein the size will be recorded for later comparison. This will then be re-assessed at 6 weeks post-surgery to allow the change in venous diameter to be assessed.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with adverse events</measure>
    <time_frame>6 weeks</time_frame>
    <description>Those receiving the active patch will be compared with those receiving the placebo patch for adverse events</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>Renal Failure</condition>
  <arm_group>
    <arm_group_label>GTN patch</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>GTN patch 5mg, in situ 24hrs</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo patch</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo patch, in situ for 24hrs</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>GTN patch</intervention_name>
    <arm_group_label>GTN patch</arm_group_label>
    <other_name>Minitran 5</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo comparator</intervention_name>
    <description>This arm will be a placebo patch to the active drug patch to blind the trial.</description>
    <arm_group_label>Placebo patch</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Primary arteriovenous fistulas&#xD;
&#xD;
               -  Brachiocephalic&#xD;
&#xD;
               -  Radiocephalic (both proximal and distal)&#xD;
&#xD;
          -  &gt;18 yrs old&#xD;
&#xD;
          -  Diabetics and smokers will be eligible for inclusion&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  All complex vascular access procedures&#xD;
&#xD;
               -  Re-do brachiocephalic and radiocephalic fistulas&#xD;
&#xD;
               -  Brachiobasilic fistulas&#xD;
&#xD;
               -  Prosthetic grafts&#xD;
&#xD;
          -  Cardiovascular dysfunction&#xD;
&#xD;
               -  Hypotension (systolic &lt;90)&#xD;
&#xD;
               -  Obstructive Cardiomyopathy&#xD;
&#xD;
               -  Severe Aortic stenosis (gradient &gt;40mmhg)&#xD;
&#xD;
               -  Confirmed myocardial infarction within the last 6 months&#xD;
&#xD;
          -  Marked anaemia (Hb&lt;8)&#xD;
&#xD;
          -  Migraine&#xD;
&#xD;
          -  Medications&#xD;
&#xD;
               -  Sildenafil&#xD;
&#xD;
               -  Pre-existing nitrate use&#xD;
&#xD;
          -  Nitrate allergy&#xD;
&#xD;
          -  Closed-angle glaucoma&#xD;
&#xD;
          -  Chronically raised intra-cranial pressure&#xD;
&#xD;
          -  History of hypothyroid disease&#xD;
&#xD;
          -  &lt; 18 years old&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nicholas G Inston, FRCS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Birmingham, UK.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Queen Elizabeth Hospital, Birmingham.</name>
      <address>
        <city>Birmingham</city>
        <state>West Midlands</state>
        <zip>B15 2TH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <reference>
    <citation>Huijbregts HJ, Bots ML, Wittens CH, Schrama YC, Moll FL, Blankestijn PJ; CIMINO study group. Hemodialysis arteriovenous fistula patency revisited: results of a prospective, multicenter initiative. Clin J Am Soc Nephrol. 2008 May;3(3):714-9. doi: 10.2215/CJN.02950707. Epub 2008 Feb 6.</citation>
    <PMID>18256379</PMID>
  </reference>
  <reference>
    <citation>Akin EB, Topcu O, Ozcan H, Ersoz S, Aytac S, Anadol E. Hemodynamic effect of transdermal glyceryl trinitrate on newly constructed arteriovenous fistula. World J Surg. 2002 Oct;26(10):1256-9. doi: 10.1007/s00268-002-6515-1. Epub 2002 Sep 4.</citation>
    <PMID>12205547</PMID>
  </reference>
  <verification_date>June 2015</verification_date>
  <study_first_submitted>August 30, 2012</study_first_submitted>
  <study_first_submitted_qc>September 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 14, 2012</study_first_posted>
  <last_update_submitted>June 1, 2015</last_update_submitted>
  <last_update_submitted_qc>June 1, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 2, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital Birmingham</investigator_affiliation>
    <investigator_full_name>Mr Nick Inston</investigator_full_name>
    <investigator_title>Consultant Surgeon</investigator_title>
  </responsible_party>
  <keyword>Arteriovenous fistula</keyword>
  <keyword>Patency</keyword>
  <keyword>GTN patch</keyword>
  <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>
  <!-- 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/NCT01685710
org study id: RRK4178
nct id: NCT01685710
lead sponsor: 
has dmc: Yes
The aim of the study is to determine whether the application of a glyceryl trinitrate patch
      (GTN patch) helps arteriovenous fistulas, created for renal dialysis access, mature so that
      they can be used.
Patients with end stage renal failure on haemodialysis must have a mechanism for achieving
      access to their vascular system for dialysis. Arteriovenous fistulas (surgically created
      connections between the artery and vein) are critical for the majority of patients. Not all
      the fistulas that are created work, a proportion fail early on and need to be revised or an
      alternative fistula created. A recent multicentre study demonstrated a 40% primary failure
      rate(1). In an attempt to increase the numbers of fistulae that reach maturation sufficient
      for dialysis access cannulation some renal centres apply GTN patches to the fistula at the
      time of surgery. It is thought that this works by increasing the size of the blood vessels
      and promoting blood flow through them and some preliminary work seems to support this(2).

      The evidence for the use of GTN patches in arteriovenous fistula creation is theoretical or
      based on preliminary work rather than robust evidence. Similarly no evidence exists within
      the literature to determine the safety and definite efficacy of this procedure in this
      population. We propose to conduct a double-blinded randomised control trial to answer the
      study question: does the application of a GTN patch increase the venous outflow diameter post
      fistula formation and does this result in improved fistula patency.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change to diameter of vein
time frame: Initial assessment and 6 weeks after surgery
description: At initial assessment of the vein the size will be recorded for later comparison. This will then be re-assessed at 6 weeks post-surgery to allow the change in venous diameter to be assessed.
measure: Number of participants with adverse events
time frame: 6 weeks
description: Those receiving the active patch will be compared with those receiving the placebo patch for adverse events
arm group label: GTN patch
arm group type: Experimental
description: GTN patch 5mg, in situ 24hrs
arm group label: Placebo patch
arm group type: Placebo Comparator
description: Placebo patch, in situ for 24hrs
intervention type: Drug
intervention name: GTN patch
arm group label: GTN patch
other name: Minitran 5
intervention type: Drug
intervention name: placebo comparator
description: This arm will be a placebo patch to the active drug patch to blind the trial.
arm group label: Placebo patch
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Nicholas G Inston, FRCS
role: Principal Investigator
affiliation: University Hospital Birmingham, UK.
facility: 
country: United Kingdom
citation: Huijbregts HJ, Bots ML, Wittens CH, Schrama YC, Moll FL, Blankestijn PJ; CIMINO study group. Hemodialysis arteriovenous fistula patency revisited: results of a prospective, multicenter initiative. Clin J Am Soc Nephrol. 2008 May;3(3):714-9. doi: 10.2215/CJN.02950707. Epub 2008 Feb 6.
PMID: 18256379
citation: Akin EB, Topcu O, Ozcan H, Ersoz S, Aytac S, Anadol E. Hemodynamic effect of transdermal glyceryl trinitrate on newly constructed arteriovenous fistula. World J Surg. 2002 Oct;26(10):1256-9. doi: 10.1007/s00268-002-6515-1. Epub 2002 Sep 4.
PMID: 12205547
responsible party type: Principal Investigator
investigator affiliation: University Hospital Birmingham
investigator full name: Mr Nick Inston
investigator title: Consultant Surgeon
mesh term: Arteriovenous Fistula
mesh term: Fistula