<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/NCT03011827</url>
  </required_header>
  <id_info>
    <org_study_id>ATR100F</org_study_id>
    <nct_id>NCT03011827</nct_id>
  </id_info>
  <brief_title>Thromboelastometry in Liver Transplantation</brief_title>
  <official_title>Transfusion Prediction Model in Orthotopic Liver Transplantation Based on Thromboelastometry: Prospective Validation Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Clinic of Barcelona</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital Clinic of Barcelona</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>
      Thromboelastometry better assess coagulation than standard coagulation test in patients&#xD;
      undergoing ortothopic liver transplantation. In a post-hoc analysis from a randomized study&#xD;
      recently conducted by our group, presurgical values of MA10 Extem &lt; 35 mm are highly&#xD;
      predictive of RBC administration , with no further improvement over MA10 Extem &gt;40 mm ;&#xD;
      suggesting that MA10 Extem between 35-40 would be the optimal range to manage blood product&#xD;
      administration. The aim of the study is to validate this result in a prospective cohort of&#xD;
      patients submitted to ortothopic liver transplantation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 1, 2019</start_date>
  <completion_date type="Anticipated">October 2022</completion_date>
  <primary_completion_date type="Anticipated">September 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Red blood cell transfusion</measure>
    <time_frame>until 24h after liver transplant</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Thrombosis</measure>
    <time_frame>28 days after liver transplant</time_frame>
    <description>Thrombosis will be assessed clinically and confirmed by ultrasonographic exam</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">65</enrollment>
  <condition>Liver Transplant Disorder</condition>
  <condition>Coagulopathy</condition>
  <arm_group>
    <arm_group_label>Prospective cohort</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Fibrinogen and/or platelet administration</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Fibrinogen and/or platelets administration</intervention_name>
    <description>Fibrinogen and/or platelets administration to maintain clot amplitude at 10 minutes of the thromboelastometry between 35-40 mm along liver transplant procedure</description>
    <arm_group_label>Prospective cohort</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Presurgical hemoglobin &lt; 13 d/L and clot firmness at 10 minutes Extem &lt; 35 mm&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous thrombosis&#xD;
&#xD;
          -  Antithrombotic treatment&#xD;
&#xD;
          -  No consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Annabel Blasi, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Clinic Barcelona. IDIBAPS</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Annabel Blasi, MD, PhD</last_name>
    <phone>+34679500857</phone>
    <email>ablasi@clinic.ub.es</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hospital Universitari de Bellvitge</name>
      <address>
        <city>L'Hospitalet de Llobregat</city>
        <state>Barcelona</state>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Antoni Sabaté, Professor</last_name>
      <email>asabatep@ub.edu; asabatep@bellvitgehospital.cat</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital de Cruces</name>
      <address>
        <city>Bilbao</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Rosa Gutierrez, MD, PhD</last_name>
      <email>rogurico@hotmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>January 4, 2017</study_first_submitted>
  <study_first_submitted_qc>January 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 5, 2017</study_first_posted>
  <last_update_submitted>August 6, 2019</last_update_submitted>
  <last_update_submitted_qc>August 6, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 7, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Clinic of Barcelona</investigator_affiliation>
    <investigator_full_name>Annabel Blasi</investigator_full_name>
    <investigator_title>Anesthesiologist</investigator_title>
  </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/NCT03011827
org study id: ATR100F
nct id: NCT03011827
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Thromboelastometry better assess coagulation than standard coagulation test in patients
      undergoing ortothopic liver transplantation. In a post-hoc analysis from a randomized study
      recently conducted by our group, presurgical values of MA10 Extem < 35 mm are highly
      predictive of RBC administration , with no further improvement over MA10 Extem >40 mm ;
      suggesting that MA10 Extem between 35-40 would be the optimal range to manage blood product
      administration. The aim of the study is to validate this result in a prospective cohort of
      patients submitted to ortothopic liver transplantation.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Red blood cell transfusion
time frame: until 24h after liver transplant
measure: Thrombosis
time frame: 28 days after liver transplant
description: Thrombosis will be assessed clinically and confirmed by ultrasonographic exam
arm group label: Prospective cohort
arm group type: Experimental
description: Fibrinogen and/or platelet administration
intervention type: Other
intervention name: Fibrinogen and/or platelets administration
description: Fibrinogen and/or platelets administration to maintain clot amplitude at 10 minutes of the thromboelastometry between 35-40 mm along liver transplant procedure
arm group label: Prospective cohort
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Annabel Blasi, MD, PhD
role: Principal Investigator
affiliation: Hospital Clinic Barcelona. IDIBAPS
last name: Annabel Blasi, MD, PhD
phone: +34679500857
email: ablasi@clinic.ub.es
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Hospital Clinic of Barcelona
investigator full name: Annabel Blasi
investigator title: Anesthesiologist
mesh term: Hemostatic Disorders
mesh term: Blood Coagulation Disorders
sharing ipd: Undecided