<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/NCT02990273</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00113092</org_study_id>
    <nct_id>NCT02990273</nct_id>
  </id_info>
  <brief_title>The Utility of Thromboelastography in Cirrhotic Patients Undergoing Endoscopic Procedures</brief_title>
  <official_title>The Utility of Thromboelastography in Cirrhotic Patients Undergoing Endoscopic Procedures</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Johns Hopkins University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cirrhosis results in decreased synthesis of both procoagulants and anticoagulants resulting&#xD;
      in &quot;rebalanced homeostasis&quot;. However, conventional blood tests (platelets/ INR levels) that&#xD;
      are performed prior to invasive procedures do not accurately reflect the coagulation changes&#xD;
      that occur in cirrhotics, resulting in unnecessary transfusion of blood products.&#xD;
      Thromboelastography (TEG) is a global hemostasis assessment tool that is being used in&#xD;
      surgery (including liver transplant) to help guide blood product transfusion in the operating&#xD;
      room. The investigators would like to compare the use of TEG vs. INR/platelets to help guide&#xD;
      blood product transfusion in cirrhotic patients undergoing inpatient endoscopy. The&#xD;
      investigators will evaluate to see if there is a decrease in prophylactic blood transfusions&#xD;
      prior to endoscopy when using TEG.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    No funding source available which was required for IRB approval&#xD;
  </why_stopped>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">January 19, 2021</completion_date>
  <primary_completion_date type="Actual">January 19, 2021</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Units of fresh frozen plasma (FFP) and platelet transfused</measure>
    <time_frame>2 week</time_frame>
    <description>Will compare how much FFP and platelet transfusion patients receiving between 2 groups.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1</enrollment>
  <condition>Cirrhosis, Coagulopathy</condition>
  <arm_group>
    <arm_group_label>TEG</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Blood transfusion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Prothrombin Time (PT)/International normalized ratio (INR)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Blood transfusion</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Blood transfusion</intervention_name>
    <arm_group_label>Prothrombin Time (PT)/International normalized ratio (INR)</arm_group_label>
    <arm_group_label>TEG</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All 18 yo + cirrhotic patients who are being scheduled for inpatient endoscopy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients on blood thinners (prophylactic anticoagulation is permissible)&#xD;
&#xD;
          -  Hemodynamically unstable patients requiring pressors (ie ICU level patients)&#xD;
&#xD;
          -  Pregnant or lactating individuals&#xD;
&#xD;
          -  Inability to provide consent for any reason&#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>Tinsay Woreta</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>October 14, 2016</study_first_submitted>
  <study_first_submitted_qc>December 8, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 13, 2016</study_first_posted>
  <last_update_submitted>January 19, 2021</last_update_submitted>
  <last_update_submitted_qc>January 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 22, 2021</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>Hemostatic Disorders</mesh_term>
    <mesh_term>Blood Coagulation Disorders</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/NCT02990273
org study id: IRB00113092
nct id: NCT02990273
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Cirrhosis results in decreased synthesis of both procoagulants and anticoagulants resulting
      in "rebalanced homeostasis". However, conventional blood tests (platelets/ INR levels) that
      are performed prior to invasive procedures do not accurately reflect the coagulation changes
      that occur in cirrhotics, resulting in unnecessary transfusion of blood products.
      Thromboelastography (TEG) is a global hemostasis assessment tool that is being used in
      surgery (including liver transplant) to help guide blood product transfusion in the operating
      room. The investigators would like to compare the use of TEG vs. INR/platelets to help guide
      blood product transfusion in cirrhotic patients undergoing inpatient endoscopy. The
      investigators will evaluate to see if there is a decrease in prophylactic blood transfusions
      prior to endoscopy when using TEG.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Units of fresh frozen plasma (FFP) and platelet transfused
time frame: 2 week
description: Will compare how much FFP and platelet transfusion patients receiving between 2 groups.
arm group label: TEG
arm group type: Active Comparator
description: Blood transfusion
arm group label: Prothrombin Time (PT)/International normalized ratio (INR)
arm group type: Active Comparator
description: Blood transfusion
intervention type: Biological
intervention name: Blood transfusion
arm group label: Prothrombin Time (PT)/International normalized ratio (INR)
arm group label: TEG
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Tinsay Woreta
role: Principal Investigator
affiliation: Johns Hopkins University
responsible party type: Sponsor
mesh term: Hemostatic Disorders
mesh term: Blood Coagulation Disorders
sharing ipd: Undecided