<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/NCT01711957</url>
  </required_header>
  <id_info>
    <org_study_id>EK-1487</org_study_id>
    <nct_id>NCT01711957</nct_id>
  </id_info>
  <brief_title>The Perioperative Value of Platelet Counts in Predicting Outcome After Liver Transplantation</brief_title>
  <official_title>The Perioperative Value of Platelet Counts in Predicting Outcome After Liver Transplantation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Zurich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Zurich</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Recent experimental and clinical studies have shown that platelets play a critical role in&#xD;
      liver ischemia and regeneration. Thrombocytopenia, a frequent and potentially serious&#xD;
      condition in liver transplantation (LT) recipients, was shown to be associated with&#xD;
      postoperative morbidity and mortality after partial hepatectomy.&#xD;
&#xD;
      The investigators aim at evaluating whether postoperative low platelet counts are indicators&#xD;
      of short- and long-term outcomes after liver transplantation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>January 2008</start_date>
  <completion_date type="Anticipated">January 2013</completion_date>
  <primary_completion_date type="Anticipated">January 2013</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>Severe complication after liver transplantation</measure>
    <time_frame>90 days</time_frame>
    <description>The severity of complications will be graded according to the Clavien-Dindo classification by outcome. Grade III to V complications will be considered as severe.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Primary graft non-function</measure>
    <time_frame>first postoperative week</time_frame>
    <description>Defined as death or retransplantation within the first postoperative week after exclusion of technical, immunological, and infectious causes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Delayed graft function</measure>
    <time_frame>7 days after liver transplantation</time_frame>
    <description>Defined as the presence of at least one of the following parameter at 7 days after LT: serum bilirubin &gt; 10 mg/dL and International Normalized Ratio (INR) &gt;1.6 or Alanine aminotransferase serum level (ALT) &gt;2000UI/L</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Patient survival</measure>
    <time_frame>3-year</time_frame>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">250</enrollment>
  <condition>Complication</condition>
  <condition>Death</condition>
  <arm_group>
    <arm_group_label>Liver disease and liver transplantation</arm_group_label>
    <description>Patient with end stage liver disease and/or primary liver tumor undergoing liver transplantation</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Liver transplantation</intervention_name>
    <description>Standardized technique of liver transplantation Organ procurement follow the rules of the Swiss transplant society</description>
    <arm_group_label>Liver disease and liver transplantation</arm_group_label>
    <other_name>Orthotopic liver transplantation (OLT)</other_name>
    <other_name>Cadaveric-donor liver transplantation</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with end stage liver disease and/or primary liver tumor undergoing liver&#xD;
        transplantation&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt;18 years old&#xD;
&#xD;
          -  End stage liver disease&#xD;
&#xD;
          -  Cadaveric-donor liver transplantation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt;18 years old&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Living-related liver transplantation&#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>Mickael Lesurtel, M.D., PhD</last_name>
    <role>Study Director</role>
    <affiliation>University of Zurich</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Pierre-Alain Clavien, M.D., PhD</last_name>
    <role>Study Chair</role>
    <affiliation>University of Zurich</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dimitri A. Raptis, M.D., MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Zurich</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Emmanuel Melloul, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Zurich</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Zurich, Department of Visceral Surgery and Transplantation</name>
      <address>
        <city>Zurich</city>
        <zip>8091</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 18, 2012</study_first_submitted>
  <study_first_submitted_qc>October 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 23, 2012</study_first_posted>
  <last_update_submitted>October 23, 2012</last_update_submitted>
  <last_update_submitted_qc>October 23, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 24, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Zurich</investigator_affiliation>
    <investigator_full_name>Dimitri Aristotle Raptis</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <keyword>Complications</keyword>
  <keyword>Mortality</keyword>
  <keyword>Liver transplantation</keyword>
  <keyword>Platelet count</keyword>
  <keyword>Survival</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Extracts</mesh_term>
  </intervention_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/NCT01711957
org study id: EK-1487
nct id: NCT01711957
lead sponsor: 
has dmc: Yes
Recent experimental and clinical studies have shown that platelets play a critical role in
      liver ischemia and regeneration. Thrombocytopenia, a frequent and potentially serious
      condition in liver transplantation (LT) recipients, was shown to be associated with
      postoperative morbidity and mortality after partial hepatectomy.

      The investigators aim at evaluating whether postoperative low platelet counts are indicators
      of short- and long-term outcomes after liver transplantation.
observational model: Cohort
time perspective: Prospective
measure: Severe complication after liver transplantation
time frame: 90 days
description: The severity of complications will be graded according to the Clavien-Dindo classification by outcome. Grade III to V complications will be considered as severe.
measure: Primary graft non-function
time frame: first postoperative week
description: Defined as death or retransplantation within the first postoperative week after exclusion of technical, immunological, and infectious causes
measure: Delayed graft function
time frame: 7 days after liver transplantation
description: Defined as the presence of at least one of the following parameter at 7 days after LT: serum bilirubin > 10 mg/dL and International Normalized Ratio (INR) >1.6 or Alanine aminotransferase serum level (ALT) >2000UI/L
measure: Patient survival
time frame: 3-year
arm group label: Liver disease and liver transplantation
description: Patient with end stage liver disease and/or primary liver tumor undergoing liver transplantation
intervention type: Procedure
intervention name: Liver transplantation
description: Standardized technique of liver transplantation Organ procurement follow the rules of the Swiss transplant society
arm group label: Liver disease and liver transplantation
other name: Orthotopic liver transplantation (OLT)
other name: Cadaveric-donor liver transplantation
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mickael Lesurtel, M.D., PhD
role: Study Director
affiliation: University of Zurich
last name: Pierre-Alain Clavien, M.D., PhD
role: Study Chair
affiliation: University of Zurich
last name: Dimitri A. Raptis, M.D., MSc
role: Principal Investigator
affiliation: University of Zurich
last name: Emmanuel Melloul, M.D.
role: Principal Investigator
affiliation: University of Zurich
facility: 
country: Switzerland
responsible party type: Principal Investigator
investigator affiliation: University of Zurich
investigator full name: Dimitri Aristotle Raptis
investigator title: MD, PhD
mesh term: Liver Extracts