<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/NCT03019302</url>
  </required_header>
  <id_info>
    <org_study_id>2015-07</org_study_id>
    <nct_id>NCT03019302</nct_id>
  </id_info>
  <brief_title>Arrow Chloragard Peripherally-Inserted Central Catheters (PICC) Study</brief_title>
  <official_title>A Study to Determine the Incidence of Catheter-Related Venous Thrombosis When Using Arrow Peripherally-Inserted Central Catheters With Chlorag+Ard Technology</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Teleflex</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Arrow International</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Teleflex</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A prospective study evaluating the timing, incidence and relationship of commonly occurring&#xD;
      complications related to the use of peripherally-inserted central catheters. All subjects&#xD;
      will receive PICC access using the Arrow PICC with Chloragard Technology.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">September 2017</completion_date>
  <primary_completion_date type="Anticipated">August 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of symptomatic and asymptomatic catheter-related venous thrombosis (CVRT)</measure>
    <time_frame>within maximum 90 days dwell</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of catheter occlusion</measure>
    <time_frame>within maximum 90 days dwell</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of catheter-related bloodstream infections</measure>
    <time_frame>within maximum 90 days dwell</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Vascular Access Complication</condition>
  <condition>Vascular Access Related Infection</condition>
  <arm_group>
    <arm_group_label>Arrow PICC with Chloragard Technology</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Arrow Peripherally- Inserted Central Catheters with Chloragard Technology. The application of Chlorag+ard® Technology uses a proprietary process whereby chlorhexidine is chemically bonded to the intra- luminal catheter surfaces from tip to hub, and extra-luminal catheter body.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Arrow PICC with Chloragard Technology</intervention_name>
    <description>chlorhexidine is chemically bonded to the intra- luminal catheter surfaces from tip to hub, and extra-luminal catheter body</description>
    <arm_group_label>Arrow PICC with Chloragard Technology</arm_group_label>
    <other_name>Chloragard PICC</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients age ≥ 18 years requiring a PICC for a period of fourteen days or greater&#xD;
             (note: maximum study period is 90 days)&#xD;
&#xD;
          -  Ability to comply with study requirements inclusive of the follow-up duplex ultrasound&#xD;
             procedures and, as applicable, recording of PICC management, interventions and related&#xD;
             treatments in the inpatient and outpatient setting in the daily subject diary&#xD;
&#xD;
          -  Patients cognitively and physically able to give written consent to participate in the&#xD;
             study or patient has a legally authorized representative (LAR) who may give written&#xD;
             consent to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous history of (within 3 months) or current diagnosis of venous thrombosis within&#xD;
             the venous tract of the proposed catheter&#xD;
&#xD;
          -  History or diagnosis of peripheral or central vein stenosis (on proposed insertion&#xD;
             side)&#xD;
&#xD;
          -  History or diagnosis of veno-occlusive disease&#xD;
&#xD;
          -  History or diagnosis of superior vena cava syndrome&#xD;
&#xD;
          -  Known, pre-existing diagnosis of hypercoagulation disorder unrelated to underlying&#xD;
             disease&#xD;
&#xD;
          -  Previous enrollment in this study&#xD;
&#xD;
          -  Currently pregnant or breast feeding&#xD;
&#xD;
          -  Previous axillary lymph node dissection on the same side as intended catheter&#xD;
             insertion site unless cleared by physician and patient consent&#xD;
&#xD;
          -  Skin condition at or within 15 cm of the proposed catheter insertion site, including&#xD;
             signs and symptoms of inflammation, rash, crusts, wounds with drainage, sites of&#xD;
             intravenous infusion infiltration or extravasation, hematoma, phlebitis and or&#xD;
             thrombophlebitis&#xD;
&#xD;
          -  Medical, social, and/or psychological problems precluding subject from study&#xD;
             participation&#xD;
&#xD;
          -  Stage 2, 3 or 4 chronic kidney disease or serum creatinine &gt; 3 mg/dl or Glomerular&#xD;
             Filtration Rate (GFR) less than 60 mL per minute per 1.73 m2 unless cleared by a&#xD;
             nephrologist for participation&#xD;
&#xD;
          -  Known allergy or sensitivity to chlorhexidine&#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_contact>
    <last_name>Tatiana Puga</last_name>
    <email>tatiana.puga@teleflex.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Thomas Philbeck, PhD</last_name>
    <email>thomas.philbeck@teleflex.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Kentucky Medical Center</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40506</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hossam Elbelasi, MD</last_name>
      <email>Hossam.Elbelasi@uky.edu</email>
    </contact>
    <investigator>
      <last_name>Michael Winkler, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Detroit Medical Center</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48201</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Katee Dawood</last_name>
      <email>kdawood@wayne.edu</email>
    </contact>
    <investigator>
      <last_name>John Z Gallien, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>January 11, 2017</study_first_submitted>
  <study_first_submitted_qc>January 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 12, 2017</study_first_posted>
  <last_update_submitted>March 22, 2017</last_update_submitted>
  <last_update_submitted_qc>March 22, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 27, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</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/NCT03019302
org study id: 2015-07
nct id: NCT03019302
lead sponsor: 
collaborator: 
has dmc: No
A prospective study evaluating the timing, incidence and relationship of commonly occurring
      complications related to the use of peripherally-inserted central catheters. All subjects
      will receive PICC access using the Arrow PICC with Chloragard Technology.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Incidence of symptomatic and asymptomatic catheter-related venous thrombosis (CVRT)
time frame: within maximum 90 days dwell
measure: Incidence of catheter occlusion
time frame: within maximum 90 days dwell
measure: Incidence of catheter-related bloodstream infections
time frame: within maximum 90 days dwell
arm group label: Arrow PICC with Chloragard Technology
arm group type: Experimental
description: Arrow Peripherally- Inserted Central Catheters with Chloragard Technology. The application of Chlorag+ard® Technology uses a proprietary process whereby chlorhexidine is chemically bonded to the intra- luminal catheter surfaces from tip to hub, and extra-luminal catheter body.
intervention type: Device
intervention name: Arrow PICC with Chloragard Technology
description: chlorhexidine is chemically bonded to the intra- luminal catheter surfaces from tip to hub, and extra-luminal catheter body
arm group label: Arrow PICC with Chloragard Technology
other name: Chloragard PICC
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Tatiana Puga
email: tatiana.puga@teleflex.com
last name: Thomas Philbeck, PhD
email: thomas.philbeck@teleflex.com
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor
sharing ipd: No