<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/NCT02971111</url>
  </required_header>
  <id_info>
    <org_study_id>1318514</org_study_id>
    <nct_id>NCT02971111</nct_id>
  </id_info>
  <brief_title>Thromboelastometry in Assessment of Sepsis Coagulopathy</brief_title>
  <official_title>Evaluation of Thromboelastometry in Sepsis in Correlation to Bleeding During Invasive Procedures</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Motol</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Charles University, Czech Republic</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Motol</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to analyze occurence of bleeding complications during invasive&#xD;
      procedures in septic patients with normal tromboelastometry results despite prolonged&#xD;
      standard coagulation tests results&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">October 2016</completion_date>
  <primary_completion_date type="Actual">October 2016</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>incidence of bleeding complications</measure>
    <time_frame>2013 - 2016</time_frame>
    <description>In our group of 76 septic patients who had normal values of EXTEM despite prolonged INR/PR invasive procedures were performed without severe bleeding.</description>
  </primary_outcome>
  <enrollment type="Actual">76</enrollment>
  <condition>Thrombelastography</condition>
  <condition>Sepsis</condition>
  <eligibility>
    <study_pop>
      <textblock>
        ICU patients with sepsis who underwent invasive procedures&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  sepsis/septic shock&#xD;
&#xD;
          -  prolonged PT-INR (international normalized ratio) ≥ 1.3&#xD;
&#xD;
          -  normal ROTEM-EXTEM results.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients on antiplatelet drugs or anticoagulant therapy (heparin, vitamin K&#xD;
             antagonists…)&#xD;
&#xD;
          -  patients with cirrhosis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>24 Years</minimum_age>
    <maximum_age>89 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>November 19, 2016</study_first_submitted>
  <study_first_submitted_qc>November 19, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2016</study_first_posted>
  <last_update_submitted>September 6, 2018</last_update_submitted>
  <last_update_submitted_qc>September 6, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 10, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Motol</investigator_affiliation>
    <investigator_full_name>Durila Miroslav MUDr. Ph.D.</investigator_full_name>
    <investigator_title>clinical researcher</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sepsis</mesh_term>
    <mesh_term>Toxemia</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/NCT02971111
org study id: 1318514
nct id: NCT02971111
lead sponsor: 
collaborator: 
The purpose of this study is to analyze occurence of bleeding complications during invasive
      procedures in septic patients with normal tromboelastometry results despite prolonged
      standard coagulation tests results
observational model: Cohort
time perspective: Retrospective
measure: incidence of bleeding complications
time frame: 2013 - 2016
description: In our group of 76 septic patients who had normal values of EXTEM despite prolonged INR/PR invasive procedures were performed without severe bleeding.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 24 Years
maximum age: 89 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: University Hospital, Motol
investigator full name: Durila Miroslav MUDr. Ph.D.
investigator title: clinical researcher
mesh term: Sepsis
mesh term: Toxemia