<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/NCT03012633</url>
  </required_header>
  <id_info>
    <org_study_id>DC 2016/142</org_study_id>
    <nct_id>NCT03012633</nct_id>
  </id_info>
  <brief_title>Rapid Diagnostic of Hyperfibrinolysis in Liver Transplantation</brief_title>
  <acronym>FILYTHO</acronym>
  <official_title>Rapid Diagnostic of Hyperfibrinolysis in Liver Transplantation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Bordeaux</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Bordeaux</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      During liver transplantation (LT), hyperfibrinolysis is one of the most important&#xD;
      modification of haemostasis. It is associated with t-PA and protein C increased activity.&#xD;
      Hyperfibrinolysis is frequent, hardly predictable and associated with major bleeding. The&#xD;
      diagnostic of hyperfibrinolysis with standard laboratory tests (euglobulin lysis test, t-PA,&#xD;
      PAI-1 and D-dimers dosages) does not provide an answer in a delay compatible with the&#xD;
      clinical practice in the operating room.&#xD;
&#xD;
      The &quot;Lysis Timer&quot; is a device developed by Hyphen-Sysmex in collaboration with SD Innovation&#xD;
      and Charleroi University Hospital (Belgium). It allows the implementation of the &quot;Global&#xD;
      Fibrinolytic Capacity&quot;, or GFC test, in a complete system associating i) the reagents for in&#xD;
      vitro triggering of the clot and its lysis (contact system activators, t-PA, thrombin and&#xD;
      calcium), ii) the signal acquisition by the Lysis Timer (able to convert the analogic signal&#xD;
      of the absorbance modifications related to clot formation into a numeric signal) and iii) a&#xD;
      dedicated software treating the numeric signal to define clot lysis time.&#xD;
&#xD;
      The GFC test, using t-PA to shorten signal acquisition times, is particularly adapted to the&#xD;
      diagnosis of hyperfibrinolysis with PAI-1 collapse, of which LT is an example.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary aim of this prospective, monocentric, observational study is to evaluate the&#xD;
      Lysis Timer as a rapid diagnostic device for hyperfibrinolysis during liver transplantation.&#xD;
      Lysis times provided by this device will be compared to the euglobulin lysis times and to the&#xD;
      others parameters of fibrinolysis at the different stages of liver transplantation and more&#xD;
      specifically at the anhepatic stage and after graft revascularization.&#xD;
&#xD;
      The secondary aims are to compare the results of the Lysis Timer, the thromboelastogram, the&#xD;
      thrombin generation test and the standard laboratory tests in the context of&#xD;
      hyperfibrinolysis during liver transplantation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 9, 2017</start_date>
  <completion_date type="Actual">July 12, 2017</completion_date>
  <primary_completion_date type="Actual">June 14, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>clot lysis time</measure>
    <time_frame>during the liver transplantation surgery</time_frame>
    <description>clot lysis time obtained quickly with &quot;Lysis Timer &quot;is compared with standard laboratory tests to diagnose hyperfibrinolysis during liver transplantation surgery.</description>
  </primary_outcome>
  <enrollment type="Actual">30</enrollment>
  <condition>Liver Transplantation</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Lysis timer</intervention_name>
    <description>Lysis Timer compared with standard laboratory test to diagnose hyperfibrinolysis during liver transplantation.</description>
    <other_name>Global Fibrinolytic Capacity</other_name>
    <other_name>GFC test</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        adult patients benefiting from liver transplantation&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adult patients benefiting from liver transplantation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age under eighteen&#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>Alexandre OUATTARA, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>head of anesthesia department II</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>BORDEAUX UNIVERSITY HOSPITAL Haut Lévêque</name>
      <address>
        <city>Pessac</city>
        <zip>33604</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>January 5, 2017</study_first_submitted>
  <study_first_submitted_qc>January 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 6, 2017</study_first_posted>
  <last_update_submitted>April 7, 2023</last_update_submitted>
  <last_update_submitted_qc>April 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 10, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Bordeaux</investigator_affiliation>
    <investigator_full_name>Alexandre OUATTARA</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <keyword>hyperfibrinolysis, Lysis Timer</keyword>
  <patient_data>
    <sharing_ipd>No</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/NCT03012633
org study id: DC 2016/142
nct id: NCT03012633
lead sponsor: 
has dmc: No
During liver transplantation (LT), hyperfibrinolysis is one of the most important
      modification of haemostasis. It is associated with t-PA and protein C increased activity.
      Hyperfibrinolysis is frequent, hardly predictable and associated with major bleeding. The
      diagnostic of hyperfibrinolysis with standard laboratory tests (euglobulin lysis test, t-PA,
      PAI-1 and D-dimers dosages) does not provide an answer in a delay compatible with the
      clinical practice in the operating room.

      The "Lysis Timer" is a device developed by Hyphen-Sysmex in collaboration with SD Innovation
      and Charleroi University Hospital (Belgium). It allows the implementation of the "Global
      Fibrinolytic Capacity", or GFC test, in a complete system associating i) the reagents for in
      vitro triggering of the clot and its lysis (contact system activators, t-PA, thrombin and
      calcium), ii) the signal acquisition by the Lysis Timer (able to convert the analogic signal
      of the absorbance modifications related to clot formation into a numeric signal) and iii) a
      dedicated software treating the numeric signal to define clot lysis time.

      The GFC test, using t-PA to shorten signal acquisition times, is particularly adapted to the
      diagnosis of hyperfibrinolysis with PAI-1 collapse, of which LT is an example.
The primary aim of this prospective, monocentric, observational study is to evaluate the
      Lysis Timer as a rapid diagnostic device for hyperfibrinolysis during liver transplantation.
      Lysis times provided by this device will be compared to the euglobulin lysis times and to the
      others parameters of fibrinolysis at the different stages of liver transplantation and more
      specifically at the anhepatic stage and after graft revascularization.

      The secondary aims are to compare the results of the Lysis Timer, the thromboelastogram, the
      thrombin generation test and the standard laboratory tests in the context of
      hyperfibrinolysis during liver transplantation.
observational model: Case-Only
time perspective: Prospective
measure: clot lysis time
time frame: during the liver transplantation surgery
description: clot lysis time obtained quickly with "Lysis Timer "is compared with standard laboratory tests to diagnose hyperfibrinolysis during liver transplantation surgery.
intervention type: Device
intervention name: Lysis timer
description: Lysis Timer compared with standard laboratory test to diagnose hyperfibrinolysis during liver transplantation.
other name: Global Fibrinolytic Capacity
other name: GFC test
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Alexandre OUATTARA, MD, PhD
role: Principal Investigator
affiliation: head of anesthesia department II
facility: 
country: France
responsible party type: Principal Investigator
investigator affiliation: University Hospital, Bordeaux
investigator full name: Alexandre OUATTARA
investigator title: MD, PhD
sharing ipd: No