<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/NCT03017911</url>
  </required_header>
  <id_info>
    <org_study_id>COMPLI-PICC</org_study_id>
    <nct_id>NCT03017911</nct_id>
  </id_info>
  <brief_title>COMPLI-PICC: Study on Picclines' Complications</brief_title>
  <acronym>COMPLI-PICC</acronym>
  <official_title>Prospective Observational Study on Picclines' Complications at Brest Hospital</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Brest</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Brest</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective monocentric study of PICC Line complications use in 5 medical and one&#xD;
      surgical units of Brest Medical University Hospital.&#xD;
&#xD;
      To evaluate the incidence of the following complications: infections, thromboses, mechanical&#xD;
      and hemorrhagic, at month 3 post-intervention.&#xD;
&#xD;
      Also evaluating:&#xD;
&#xD;
        -  the management of these PICC Line related complications,&#xD;
&#xD;
        -  risk factors for such complications,&#xD;
&#xD;
        -  and the mortality-related outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All eligible patients fulfilling the inclusion criteria, after PICC Line placement, will&#xD;
      receive oral and written patient information describing the study deployment and follow-up.&#xD;
      Patients will be followed up until PICC Line removal if it occurs during the first 3 months&#xD;
      after placement or until death if it occurs during the first 3 months, or during 3 months in&#xD;
      the absence of complications.&#xD;
&#xD;
        -  Infectious complications are described in accordance with IDSA 2009 guidelines and&#xD;
           include bloodstream infection, endocarditis, local infection and septic&#xD;
           thrombophlebitis.&#xD;
&#xD;
        -  Thrombotic complications are defined as symptomatic, deep, or superficial venous&#xD;
           thrombosis, confirmed by Ultrasound and Echo-Doppler or asymptomatic venous thrombosis&#xD;
           diagnosed fortuitously.&#xD;
&#xD;
        -  Mechanical complications are defined as impairments related to PICC Line device:&#xD;
           occlusion, rupture, accidental removal.&#xD;
&#xD;
        -  Hemorrhagic complications are defined as hematoma or bleedings of puncture site.&#xD;
&#xD;
      In the event of PICC Line-related complications, patient will be followed up for an&#xD;
      additional 3 months, from the date of complication diagnosis, i.e. maximum follow-up duration&#xD;
      of 6 months.&#xD;
&#xD;
      Each week during the first month, then once monthly during the follow-up (i.e. W1, W2, W3,&#xD;
      W4, M2, M3, +/- M4, M5, M6), all patients data related to the PICC Line retention or removal,&#xD;
      use and all its related complications will be collected.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2016</start_date>
  <completion_date type="Anticipated">September 2017</completion_date>
  <primary_completion_date type="Anticipated">September 2017</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Complication in patient with piccline</measure>
    <time_frame>3 month</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">120</enrollment>
  <condition>PICC Line Placement</condition>
  <arm_group>
    <arm_group_label>Patients with PICC Lines</arm_group_label>
    <description>All patients included in this study have undergone PICC Line placement before enrollment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Piccline</intervention_name>
    <arm_group_label>Patients with PICC Lines</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients &gt; 18 yo from internal medicine, pneumology, nutrition, oncology, hematology, and&#xD;
        cardiac and vascular surgery - who underwent PICC Line placement between October 10, 2016&#xD;
        and March 9, 2017 will be included in the study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient &gt; 18 yo&#xD;
&#xD;
          -  Patients &gt; 18 yo hospitalized in internal medicine, pneumology, nutrition, oncology,&#xD;
             hematology, and cardiac and vascular surgery - who underwent PICC Line placement&#xD;
             between October 10, 2016 and March 9, 2017&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients hospitalized in other units than those cited above&#xD;
&#xD;
          -  Patients verbal refusal to participate in the study&#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>Claire DE MOREUIL</last_name>
    <email>claire.demoreuil@chu-brest.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>CHRU de Brest</name>
      <address>
        <city>Brest</city>
        <zip>29200</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Claire de Moreuil, M.D.</last_name>
      <phone>0298145303</phone>
      <email>claire.demoreuil@chu-brest.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <reference>
    <citation>Mermel LA, Allon M, Bouza E, Craven DE, Flynn P, O'Grady NP, Raad II, Rijnders BJ, Sherertz RJ, Warren DK. Clinical practice guidelines for the diagnosis and management of intravascular catheter-related infection: 2009 Update by the Infectious Diseases Society of America. Clin Infect Dis. 2009 Jul 1;49(1):1-45. doi: 10.1086/599376. Erratum In: Clin Infect Dis. 2010 Apr 1;50(7):1079. Dosage error in article text. Clin Infect Dis. 2010 Feb 1;50(3):457.</citation>
    <PMID>19489710</PMID>
  </reference>
  <reference>
    <citation>O'Grady NP, Alexander M, Burns LA, Dellinger EP, Garland J, Heard SO, Lipsett PA, Masur H, Mermel LA, Pearson ML, Raad II, Randolph AG, Rupp ME, Saint S; Healthcare Infection Control Practices Advisory Committee. Guidelines for the prevention of intravascular catheter-related infections. Am J Infect Control. 2011 May;39(4 Suppl 1):S1-34. doi: 10.1016/j.ajic.2011.01.003. No abstract available.</citation>
    <PMID>21511081</PMID>
  </reference>
  <reference>
    <citation>Safdar N, Maki DG. Risk of catheter-related bloodstream infection with peripherally inserted central venous catheters used in hospitalized patients. Chest. 2005 Aug;128(2):489-95. doi: 10.1378/chest.128.2.489.</citation>
    <PMID>16100130</PMID>
  </reference>
  <reference>
    <citation>Chopra V, Ratz D, Kuhn L, Lopus T, Chenoweth C, Krein S. PICC-associated bloodstream infections: prevalence, patterns, and predictors. Am J Med. 2014 Apr;127(4):319-28. doi: 10.1016/j.amjmed.2014.01.001. Epub 2014 Jan 17.</citation>
    <PMID>24440542</PMID>
  </reference>
  <reference>
    <citation>Chemaly RF, de Parres JB, Rehm SJ, Adal KA, Lisgaris MV, Katz-Scott DS, Curtas S, Gordon SM, Steiger E, Olin J, Longworth DL. Venous thrombosis associated with peripherally inserted central catheters: a retrospective analysis of the Cleveland Clinic experience. Clin Infect Dis. 2002 May 1;34(9):1179-83. doi: 10.1086/339808. Epub 2002 Apr 3.</citation>
    <PMID>11941543</PMID>
  </reference>
  <reference>
    <citation>Vidal V, Muller C, Jacquier A, Giorgi R, Le Corroller T, Gaubert J, Champsaur P, Bartoli J, Moulin G. [Prospective evaluation of PICC line related complications]. J Radiol. 2008 Apr;89(4):495-8. doi: 10.1016/s0221-0363(08)71453-7. French.</citation>
    <PMID>18477956</PMID>
  </reference>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>January 10, 2017</study_first_submitted>
  <study_first_submitted_qc>January 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 11, 2017</study_first_posted>
  <last_update_submitted>January 10, 2017</last_update_submitted>
  <last_update_submitted_qc>January 10, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>PICC Line</keyword>
  <keyword>Complications</keyword>
  <keyword>Thrombosis</keyword>
  <keyword>Infection</keyword>
  <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/NCT03017911
org study id: COMPLI-PICC
nct id: NCT03017911
lead sponsor: 
has dmc: No
This is a prospective monocentric study of PICC Line complications use in 5 medical and one
      surgical units of Brest Medical University Hospital.

      To evaluate the incidence of the following complications: infections, thromboses, mechanical
      and hemorrhagic, at month 3 post-intervention.

      Also evaluating:

        -  the management of these PICC Line related complications,

        -  risk factors for such complications,

        -  and the mortality-related outcomes.
All eligible patients fulfilling the inclusion criteria, after PICC Line placement, will
      receive oral and written patient information describing the study deployment and follow-up.
      Patients will be followed up until PICC Line removal if it occurs during the first 3 months
      after placement or until death if it occurs during the first 3 months, or during 3 months in
      the absence of complications.

        -  Infectious complications are described in accordance with IDSA 2009 guidelines and
           include bloodstream infection, endocarditis, local infection and septic
           thrombophlebitis.

        -  Thrombotic complications are defined as symptomatic, deep, or superficial venous
           thrombosis, confirmed by Ultrasound and Echo-Doppler or asymptomatic venous thrombosis
           diagnosed fortuitously.

        -  Mechanical complications are defined as impairments related to PICC Line device:
           occlusion, rupture, accidental removal.

        -  Hemorrhagic complications are defined as hematoma or bleedings of puncture site.

      In the event of PICC Line-related complications, patient will be followed up for an
      additional 3 months, from the date of complication diagnosis, i.e. maximum follow-up duration
      of 6 months.

      Each week during the first month, then once monthly during the follow-up (i.e. W1, W2, W3,
      W4, M2, M3, +/- M4, M5, M6), all patients data related to the PICC Line retention or removal,
      use and all its related complications will be collected.
observational model: Cohort
time perspective: Prospective
measure: Complication in patient with piccline
time frame: 3 month
arm group label: Patients with PICC Lines
description: All patients included in this study have undergone PICC Line placement before enrollment.
intervention type: Procedure
intervention name: Piccline
arm group label: Patients with PICC Lines
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Claire DE MOREUIL
email: claire.demoreuil@chu-brest.fr
facility: 
status: Recruiting
contact: 
country: France
citation: Mermel LA, Allon M, Bouza E, Craven DE, Flynn P, O'Grady NP, Raad II, Rijnders BJ, Sherertz RJ, Warren DK. Clinical practice guidelines for the diagnosis and management of intravascular catheter-related infection: 2009 Update by the Infectious Diseases Society of America. Clin Infect Dis. 2009 Jul 1;49(1):1-45. doi: 10.1086/599376. Erratum In: Clin Infect Dis. 2010 Apr 1;50(7):1079. Dosage error in article text. Clin Infect Dis. 2010 Feb 1;50(3):457.
PMID: 19489710
citation: O'Grady NP, Alexander M, Burns LA, Dellinger EP, Garland J, Heard SO, Lipsett PA, Masur H, Mermel LA, Pearson ML, Raad II, Randolph AG, Rupp ME, Saint S; Healthcare Infection Control Practices Advisory Committee. Guidelines for the prevention of intravascular catheter-related infections. Am J Infect Control. 2011 May;39(4 Suppl 1):S1-34. doi: 10.1016/j.ajic.2011.01.003. No abstract available.
PMID: 21511081
citation: Safdar N, Maki DG. Risk of catheter-related bloodstream infection with peripherally inserted central venous catheters used in hospitalized patients. Chest. 2005 Aug;128(2):489-95. doi: 10.1378/chest.128.2.489.
PMID: 16100130
citation: Chopra V, Ratz D, Kuhn L, Lopus T, Chenoweth C, Krein S. PICC-associated bloodstream infections: prevalence, patterns, and predictors. Am J Med. 2014 Apr;127(4):319-28. doi: 10.1016/j.amjmed.2014.01.001. Epub 2014 Jan 17.
PMID: 24440542
citation: Chemaly RF, de Parres JB, Rehm SJ, Adal KA, Lisgaris MV, Katz-Scott DS, Curtas S, Gordon SM, Steiger E, Olin J, Longworth DL. Venous thrombosis associated with peripherally inserted central catheters: a retrospective analysis of the Cleveland Clinic experience. Clin Infect Dis. 2002 May 1;34(9):1179-83. doi: 10.1086/339808. Epub 2002 Apr 3.
PMID: 11941543
citation: Vidal V, Muller C, Jacquier A, Giorgi R, Le Corroller T, Gaubert J, Champsaur P, Bartoli J, Moulin G. [Prospective evaluation of PICC line related complications]. J Radiol. 2008 Apr;89(4):495-8. doi: 10.1016/s0221-0363(08)71453-7. French.
PMID: 18477956
responsible party type: Sponsor
sharing ipd: No