<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/NCT03814031</url>
  </required_header>
  <id_info>
    <org_study_id>12156</org_study_id>
    <nct_id>NCT03814031</nct_id>
  </id_info>
  <brief_title>Hepatic Vein Flow During Orthotopic Liver Transplantation as Predictive Factor for Postoperative Graft Function</brief_title>
  <official_title>Hepatic Vein Flow Assessment With Transesophageal Echocardiography for Postoperative Graft Function Prediction in Orthotopic Liver Transplantation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Henry Ford Health System</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Henry Ford Health System</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>
      Hepatic vein flow (HVF) assessment using transesophageal echocardiography (TEE) has a&#xD;
      potential to predict postoperative graft function in orthotopic liver transplant (OLT).&#xD;
      Investigators will measure HVF using TEE and assess the correlation with postoperative graft&#xD;
      function indices such as early allograft dysfunction(EAD), prolonged INR, platelet, and total&#xD;
      bilirubin.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      During OLT, intraoperative TEE assessment of HVF (systolic and diastolic) were measured, and&#xD;
      adjusted with donor graft weight. This index, HVF index, was assessed for correlation with&#xD;
      EAD. HVF was calculated with hepatic vein area (cm2) x hepatic vein velocity (ml/s) in&#xD;
      systole and diastole during the neohepatic phase. Investigators did ROC analysis to assess&#xD;
      the predictive power for EAD, prolonged INR, platelet, and total bilirubin.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 20, 2018</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">December 31, 2019</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>EAD</measure>
    <time_frame>within the first 7 days status post OLT</time_frame>
    <description>Primary outcome was early allograft dysfunction (EAD), which was defined by the presence of one or more of the following: total bilirubin (t-bil) ≥ 10 mg/dL (171 μmol/L) or, INR ≥ 1.6 on day 7, and ALT/AST &gt; 2,000 IU/L</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Acute rejection</measure>
    <time_frame>within 6-8 weeks post transplant</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prolonged (&gt; 7 days) time to normalize total bilirubin (TIME t-bil), prolonged (&gt;7 days) time to normalize INR (TIME inr), and prolonged (&gt;7 days) time to normalize platelet count (TIME plt).</measure>
    <time_frame>&gt; 7 days post transplant</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">97</enrollment>
  <condition>Postoperative Graft Function</condition>
  <arm_group>
    <arm_group_label>EAD</arm_group_label>
    <description>Early allograft dysfunction (EAD), which was defined by the presence of one or more of the following: total bilirubin (t-bil) ≥ 10 mg/dL (171 μmol/L) or, INR ≥ 1.6 on day 7, and ALT/AST &gt; 2,000 IU/L within the first 7 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non EAD</arm_group_label>
    <description>No EAD</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>NO internvention</intervention_name>
    <description>NO internvention</description>
    <arm_group_label>EAD</arm_group_label>
    <arm_group_label>Non EAD</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        OLT with piggy back technique&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Orthotopic liver transplants which uses TEE intraoperatively Must be Piggy back technique&#xD;
&#xD;
        -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        TEE absolute contraindication patient refusal&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yoshihisa Morita, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Henry Ford Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>HFHS</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>January 16, 2019</study_first_submitted>
  <study_first_submitted_qc>January 22, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>November 3, 2020</last_update_submitted>
  <last_update_submitted_qc>November 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Henry Ford Health System</investigator_affiliation>
    <investigator_full_name>Yoshihisa Morita</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>TEE</keyword>
  <keyword>orthotopic liver transplant</keyword>
  <keyword>EAD</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>December 11, 2022</submitted>
  </pending_results>
  <!-- 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/NCT03814031
org study id: 12156
nct id: NCT03814031
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Hepatic vein flow (HVF) assessment using transesophageal echocardiography (TEE) has a
      potential to predict postoperative graft function in orthotopic liver transplant (OLT).
      Investigators will measure HVF using TEE and assess the correlation with postoperative graft
      function indices such as early allograft dysfunction(EAD), prolonged INR, platelet, and total
      bilirubin.
During OLT, intraoperative TEE assessment of HVF (systolic and diastolic) were measured, and
      adjusted with donor graft weight. This index, HVF index, was assessed for correlation with
      EAD. HVF was calculated with hepatic vein area (cm2) x hepatic vein velocity (ml/s) in
      systole and diastole during the neohepatic phase. Investigators did ROC analysis to assess
      the predictive power for EAD, prolonged INR, platelet, and total bilirubin.
observational model: Cohort
time perspective: Prospective
measure: EAD
time frame: within the first 7 days status post OLT
description: Primary outcome was early allograft dysfunction (EAD), which was defined by the presence of one or more of the following: total bilirubin (t-bil) ≥ 10 mg/dL (171 μmol/L) or, INR ≥ 1.6 on day 7, and ALT/AST > 2,000 IU/L
measure: Acute rejection
time frame: within 6-8 weeks post transplant
measure: Prolonged (> 7 days) time to normalize total bilirubin (TIME t-bil), prolonged (>7 days) time to normalize INR (TIME inr), and prolonged (>7 days) time to normalize platelet count (TIME plt).
time frame: > 7 days post transplant
arm group label: EAD
description: Early allograft dysfunction (EAD), which was defined by the presence of one or more of the following: total bilirubin (t-bil) ≥ 10 mg/dL (171 μmol/L) or, INR ≥ 1.6 on day 7, and ALT/AST > 2,000 IU/L within the first 7 days.
arm group label: Non EAD
description: No EAD
intervention type: Other
intervention name: NO internvention
description: NO internvention
arm group label: EAD
arm group label: Non EAD
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Yoshihisa Morita, MD
role: Principal Investigator
affiliation: Henry Ford Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Henry Ford Health System
investigator full name: Yoshihisa Morita
investigator title: MD
sharing ipd: No
submitted: December 11, 2022