<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/NCT04503135</url>
  </required_header>
  <id_info>
    <org_study_id>172_2020</org_study_id>
    <nct_id>NCT04503135</nct_id>
  </id_info>
  <brief_title>Catheter Associated Asymptomatic Thrombosis in Intensive Care Unit</brief_title>
  <acronym>CAAT</acronym>
  <official_title>Prospective Cohort Study on Catheter Associated Asymptomatic Thrombosis in Intensive Care Unit</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Policlinico Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Policlinico Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to describe the incidence of catheter-related and non-catheter-related&#xD;
      thrombosis in a population of adults in ICU and to assess its correlation with alteration of&#xD;
      coagulation parameters.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Central venous catheter (CVC) is now indispensable in the monitoring and care of patients in&#xD;
      intensive care (ICU). Unfortunately, one of the complications of its positioning is&#xD;
      catheter-related thrombosis (CRT) and its consequences. Despite the widespread use of CVC and&#xD;
      the extensive literature describing its complications, areas of uncertainty regarding the&#xD;
      onset, treatment and prevention of CRT persist, especially with regard to asymptomatic&#xD;
      thrombosis.&#xD;
&#xD;
      This study aims to describe the incidence of catheter-related and non-catheter-related&#xD;
      thrombosis in a population of adults in ICU and to assess its correlation with alteration of&#xD;
      coagulation parameters.&#xD;
&#xD;
      The main objective of this study is to assess the proportion of patients developing CRT&#xD;
      (proportion) and the incidence of CRT (rate expressed in catheter events/days) in patients in&#xD;
      ICU.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2020</start_date>
  <completion_date type="Actual">October 21, 2022</completion_date>
  <primary_completion_date type="Actual">October 21, 2022</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>Proportion of patients developing Catheter related thrombosis and Incidence of CRT in patients in ICU</measure>
    <time_frame>Until CVC removal</time_frame>
    <description>The main objective of this study is to assess the proportion of patients developing CRT (proportion) and the incidence of CRT (rate expressed in catheter events/days) in patients in ICU.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of various types of thrombotic apposition</measure>
    <time_frame>Until CVC removal</time_frame>
    <description>The proportion of various types of thrombotic apposition</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Deep venous thrombosis (DVT) proportion and Incidence</measure>
    <time_frame>Until CVC removal</time_frame>
    <description>The proportion of patients developing DVT and the incidence of catheter-related DVT (rate) in patients in ICU carrying CVC.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the association of thrombosis with alterations of hemocoagulative parameters</measure>
    <time_frame>Until CVC removal</time_frame>
    <description>the association of thrombosis with alterations of hemocoagulative parameters</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>describe the clinical measures that have been taken following the diagnosis of CRT.describe the clinical measures that have been taken following the diagnosis of CRT.</measure>
    <time_frame>Until CVC removal</time_frame>
    <description>describe the clinical measures that have been taken following the diagnosis of CRT.</description>
  </secondary_outcome>
  <enrollment type="Actual">203</enrollment>
  <condition>Central Venous Catheters</condition>
  <condition>Central Venous Catheter Thrombosis</condition>
  <condition>Thrombosis, Venous</condition>
  <condition>Intensive Care Unit</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>ultrasound</intervention_name>
    <description>ultrasound of the central veins of the neck and chest and a (compression ultra-sound) CUS of the femoral veins will be performed bilaterally</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Intensive Care Unit (ICU) adult patients requiring Central venous catheter for clinical&#xD;
        reasons&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients over the age of 18&#xD;
&#xD;
          -  admitted to intensive care who have for clinical reasons need to place a central&#xD;
             venous catheter&#xD;
&#xD;
          -  signing of informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients under 18 years of age&#xD;
&#xD;
          -  Known cancer status&#xD;
&#xD;
          -  Congenital thrombophilia&#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>chiara Abbruzzese, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milano</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico</name>
      <address>
        <city>Milano</city>
        <state>MI</state>
        <zip>20122</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <reference>
    <citation>Forauer AR, Theoharis CG, Dasika NL. Jugular vein catheter placement: histologic features and development of catheter-related (fibrin) sheaths in a swine model. Radiology. 2006 Aug;240(2):427-34. doi: 10.1148/radiol.2402031129.</citation>
    <PMID>16864670</PMID>
  </reference>
  <reference>
    <citation>Rooden CJ, Tesselaar ME, Osanto S, Rosendaal FR, Huisman MV. Deep vein thrombosis associated with central venous catheters - a review. J Thromb Haemost. 2005 Nov;3(11):2409-19. doi: 10.1111/j.1538-7836.2005.01398.x. Epub 2005 Jun 24. No abstract available.</citation>
    <PMID>15975139</PMID>
  </reference>
  <reference>
    <citation>Bates SM, Jaeschke R, Stevens SM, Goodacre S, Wells PS, Stevenson MD, Kearon C, Schunemann HJ, Crowther M, Pauker SG, Makdissi R, Guyatt GH. Diagnosis of DVT: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012 Feb;141(2 Suppl):e351S-e418S. doi: 10.1378/chest.11-2299.</citation>
    <PMID>22315267</PMID>
  </reference>
  <reference>
    <citation>Hrdy O, Strazevska E, Suk P, Vach R, Karlik R, Jarkovsky J, Sas I, Gal R. Central venous catheter-related thrombosis in intensive care patients - incidence and risk factors: A prospective observational study. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2017 Dec;161(4):369-373. doi: 10.5507/bp.2017.034. Epub 2017 Aug 24.</citation>
    <PMID>28839334</PMID>
  </reference>
  <reference>
    <citation>Nm Bhat M, Venkataraman R, Ramakrishnan N, K Abraham B, Rajagopalan S. Value of Routine Sonographic Screening of Internal Jugular Vein to Detect Catheter Related Thrombosis in Intensive Care Unit. Indian J Crit Care Med. 2019 Jul;23(7):326-328. doi: 10.5005/jp-journals-10071-23207. Erratum In: Indian J Crit Care Med. 2019 Oct;23(10):494.</citation>
    <PMID>31406439</PMID>
  </reference>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>August 3, 2020</study_first_submitted>
  <study_first_submitted_qc>August 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>April 28, 2023</last_update_submitted>
  <last_update_submitted_qc>April 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Policlinico Hospital</investigator_affiliation>
    <investigator_full_name>Mauro Panigada</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thrombosis</mesh_term>
    <mesh_term>Upper Extremity Deep Vein Thrombosis</mesh_term>
    <mesh_term>Venous Thrombosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04503135
org study id: 172_2020
nct id: NCT04503135
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study aims to describe the incidence of catheter-related and non-catheter-related
      thrombosis in a population of adults in ICU and to assess its correlation with alteration of
      coagulation parameters.
Central venous catheter (CVC) is now indispensable in the monitoring and care of patients in
      intensive care (ICU). Unfortunately, one of the complications of its positioning is
      catheter-related thrombosis (CRT) and its consequences. Despite the widespread use of CVC and
      the extensive literature describing its complications, areas of uncertainty regarding the
      onset, treatment and prevention of CRT persist, especially with regard to asymptomatic
      thrombosis.

      This study aims to describe the incidence of catheter-related and non-catheter-related
      thrombosis in a population of adults in ICU and to assess its correlation with alteration of
      coagulation parameters.

      The main objective of this study is to assess the proportion of patients developing CRT
      (proportion) and the incidence of CRT (rate expressed in catheter events/days) in patients in
      ICU.
observational model: Cohort
time perspective: Prospective
measure: Proportion of patients developing Catheter related thrombosis and Incidence of CRT in patients in ICU
time frame: Until CVC removal
description: The main objective of this study is to assess the proportion of patients developing CRT (proportion) and the incidence of CRT (rate expressed in catheter events/days) in patients in ICU.
measure: Proportion of various types of thrombotic apposition
time frame: Until CVC removal
description: The proportion of various types of thrombotic apposition
measure: Deep venous thrombosis (DVT) proportion and Incidence
time frame: Until CVC removal
description: The proportion of patients developing DVT and the incidence of catheter-related DVT (rate) in patients in ICU carrying CVC.
measure: the association of thrombosis with alterations of hemocoagulative parameters
time frame: Until CVC removal
description: the association of thrombosis with alterations of hemocoagulative parameters
measure: describe the clinical measures that have been taken following the diagnosis of CRT.describe the clinical measures that have been taken following the diagnosis of CRT.
time frame: Until CVC removal
description: describe the clinical measures that have been taken following the diagnosis of CRT.
intervention type: Diagnostic Test
intervention name: ultrasound
description: ultrasound of the central veins of the neck and chest and a (compression ultra-sound) CUS of the femoral veins will be performed bilaterally
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: chiara Abbruzzese, MD
role: Principal Investigator
affiliation: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milano
facility: 
country: Italy
citation: Forauer AR, Theoharis CG, Dasika NL. Jugular vein catheter placement: histologic features and development of catheter-related (fibrin) sheaths in a swine model. Radiology. 2006 Aug;240(2):427-34. doi: 10.1148/radiol.2402031129.
PMID: 16864670
citation: Rooden CJ, Tesselaar ME, Osanto S, Rosendaal FR, Huisman MV. Deep vein thrombosis associated with central venous catheters - a review. J Thromb Haemost. 2005 Nov;3(11):2409-19. doi: 10.1111/j.1538-7836.2005.01398.x. Epub 2005 Jun 24. No abstract available.
PMID: 15975139
citation: Bates SM, Jaeschke R, Stevens SM, Goodacre S, Wells PS, Stevenson MD, Kearon C, Schunemann HJ, Crowther M, Pauker SG, Makdissi R, Guyatt GH. Diagnosis of DVT: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012 Feb;141(2 Suppl):e351S-e418S. doi: 10.1378/chest.11-2299.
PMID: 22315267
citation: Hrdy O, Strazevska E, Suk P, Vach R, Karlik R, Jarkovsky J, Sas I, Gal R. Central venous catheter-related thrombosis in intensive care patients - incidence and risk factors: A prospective observational study. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2017 Dec;161(4):369-373. doi: 10.5507/bp.2017.034. Epub 2017 Aug 24.
PMID: 28839334
citation: Nm Bhat M, Venkataraman R, Ramakrishnan N, K Abraham B, Rajagopalan S. Value of Routine Sonographic Screening of Internal Jugular Vein to Detect Catheter Related Thrombosis in Intensive Care Unit. Indian J Crit Care Med. 2019 Jul;23(7):326-328. doi: 10.5005/jp-journals-10071-23207. Erratum In: Indian J Crit Care Med. 2019 Oct;23(10):494.
PMID: 31406439
responsible party type: Principal Investigator
investigator affiliation: Policlinico Hospital
investigator full name: Mauro Panigada
investigator title: Principal Investigator
mesh term: Thrombosis
mesh term: Upper Extremity Deep Vein Thrombosis
mesh term: Venous Thrombosis
sharing ipd: Undecided