<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/NCT02970409</url>
  </required_header>
  <id_info>
    <org_study_id>FIBHGM-ECNC002-2014</org_study_id>
    <nct_id>NCT02970409</nct_id>
  </id_info>
  <brief_title>Heparin Versus Saline in Peripheral Venous Catheter</brief_title>
  <official_title>A Randomized Study to Test Peripheral Venous Catheter Lock Therapy With Either Heparin or Saline in Patients Admitted to the Internal Medicine Department</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital General Universitario Gregorio Marañon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Instituto de Salud Carlos III</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Fundación para la Investigación Biomédica del Hospital Gregorio Maranon</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hospital General Universitario Gregorio Marañon</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A clinical, prospective. controlled and randomized study with patients with a peripheral&#xD;
      venous catheter. Patients will be randomized to either receive heparin or saline. The&#xD;
      investigators will monitored the clinical out come to further evaluate catheter colonization&#xD;
      rate, phlebitis rate, days of hospital stay, antimicrobial costs, and adverse effects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The need of use of peripheral venous catheters and the importance of a proper management to&#xD;
      avoid catheter colonization or phlebitis requires two possible preventive approaches: lock&#xD;
      therapy with heparin or saline.&#xD;
&#xD;
      Heparin demonstrated its efficacy in central venous catheters, but there are still&#xD;
      controversies of whether it is useful in peripheral venous catheters.&#xD;
&#xD;
      Objectives To compare the efficacy of heparin in peripheral venous catheters lock versus&#xD;
      saline for the prevention of colonization and phlebitis in patients admitted to an Internal&#xD;
      Medicine Department.&#xD;
&#xD;
      Methods: A clinical, prospective. controlled and randomized study with patients with a&#xD;
      peripheral venous catheter.&#xD;
&#xD;
      Patients will be randomized to either receive heparin or saline. The investigators will&#xD;
      monitored the clinical out come to further evaluate catheter colonization rate, phlebitis&#xD;
      rate, days of hospital stay, antimicrobial costs, and adverse effects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 17, 2015</start_date>
  <completion_date type="Actual">October 30, 2017</completion_date>
  <primary_completion_date type="Actual">October 30, 2017</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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>complications</measure>
    <time_frame>Daily from catheter insertion until catheter withdraw(estimated 10 days)</time_frame>
    <description>prevention of colonization(superficial and tip culture) and phlebitis(visual inflammation of entrance of catheter insertion) .</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>catheter related infection rate</measure>
    <time_frame>Through study completion( estimated 2 year after Last patient in)</time_frame>
    <description>episodes of catheter related infection against number of days of exposure to catheter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>adverse events(number of catheter obstructions and coagulation alterations)</measure>
    <time_frame>Through study completion (2 year afterLast patient in)</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">354</enrollment>
  <condition>Catheter-Related Infections</condition>
  <arm_group>
    <arm_group_label>heparin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Catheter Lock Therapy with Heparin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>saline</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Catheter Lock Therapy with saline</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>saline</intervention_name>
    <description>catheter lock using saline</description>
    <arm_group_label>saline</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Heparin</intervention_name>
    <description>catheter lock using Heparin</description>
    <arm_group_label>heparin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with inserted PV Catheter within 24h from admission in internal medicine&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  hypersensibility to heparin&#xD;
&#xD;
          -  active hemorrhage&#xD;
&#xD;
          -  coagulation alterations&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Internal Medicine Department HGU Gregorio Marañón</name>
      <address>
        <city>Madrid</city>
        <zip>28007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>October 15, 2015</study_first_submitted>
  <study_first_submitted_qc>November 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2016</study_first_posted>
  <last_update_submitted>December 18, 2018</last_update_submitted>
  <last_update_submitted_qc>December 18, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 20, 2018</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>Catheter-Related Infections</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heparin</mesh_term>
  </intervention_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/NCT02970409
org study id: FIBHGM-ECNC002-2014
nct id: NCT02970409
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
A clinical, prospective. controlled and randomized study with patients with a peripheral
      venous catheter. Patients will be randomized to either receive heparin or saline. The
      investigators will monitored the clinical out come to further evaluate catheter colonization
      rate, phlebitis rate, days of hospital stay, antimicrobial costs, and adverse effects.
The need of use of peripheral venous catheters and the importance of a proper management to
      avoid catheter colonization or phlebitis requires two possible preventive approaches: lock
      therapy with heparin or saline.

      Heparin demonstrated its efficacy in central venous catheters, but there are still
      controversies of whether it is useful in peripheral venous catheters.

      Objectives To compare the efficacy of heparin in peripheral venous catheters lock versus
      saline for the prevention of colonization and phlebitis in patients admitted to an Internal
      Medicine Department.

      Methods: A clinical, prospective. controlled and randomized study with patients with a
      peripheral venous catheter.

      Patients will be randomized to either receive heparin or saline. The investigators will
      monitored the clinical out come to further evaluate catheter colonization rate, phlebitis
      rate, days of hospital stay, antimicrobial costs, and adverse effects.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: complications
time frame: Daily from catheter insertion until catheter withdraw(estimated 10 days)
description: prevention of colonization(superficial and tip culture) and phlebitis(visual inflammation of entrance of catheter insertion) .
measure: catheter related infection rate
time frame: Through study completion( estimated 2 year after Last patient in)
description: episodes of catheter related infection against number of days of exposure to catheter
measure: adverse events(number of catheter obstructions and coagulation alterations)
time frame: Through study completion (2 year afterLast patient in)
arm group label: heparin
arm group type: Active Comparator
description: Catheter Lock Therapy with Heparin
arm group label: saline
arm group type: Experimental
description: Catheter Lock Therapy with saline
intervention type: Device
intervention name: saline
description: catheter lock using saline
arm group label: saline
intervention type: Device
intervention name: Heparin
description: catheter lock using Heparin
arm group label: heparin
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Spain
responsible party type: Sponsor
mesh term: Catheter-Related Infections
mesh term: Heparin