<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/NCT04475887</url>
  </required_header>
  <id_info>
    <org_study_id>1175/2017</org_study_id>
    <nct_id>NCT04475887</nct_id>
  </id_info>
  <brief_title>Treatment of Anemia With Intravenous Iron in Patients Listed for Orthotopic Liver Transplantation</brief_title>
  <acronym>TRAILER</acronym>
  <official_title>Treatment of Anemia With Intravenous Iron in Patients Listed for Orthotopic Liver Transplantation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Vienna</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Vienna</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The aim of this study is to investigate whether therapy with intravenous iron carboxymaltose&#xD;
      in patients with iron deficiency anemia (IDA) listed for orthotopic liver transplantation&#xD;
      (OLT) increases hemoglobin concentrations and reduces intraoperative transfusion of packed&#xD;
      red blood cells (PRBCs). The investigators hypothesize that therapy with intravenous iron&#xD;
      will increase hemoglobin concentrations and reduce intraoperative transfusion of PRBCs in&#xD;
      patients with IDA listed for OLT.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 23, 2020</start_date>
  <completion_date type="Anticipated">May 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2022</primary_completion_date>
  <phase>Phase 4</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>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Hemoglobin at OLT</measure>
    <time_frame>6 months</time_frame>
    <description>Change in hemoglobin concentrations from baseline until before induction of anesthesia for OLT</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Transfusion requirement</measure>
    <time_frame>6 months</time_frame>
    <description>Transfusion of PRBCs during and within the first 24 hours following OLT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hemoglobin after 4 weeks</measure>
    <time_frame>4 weeks</time_frame>
    <description>Change in hemoglobin concentrations from baseline until 4 weeks after initiation of therapy</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Liver Transplantation</condition>
  <condition>Blood Loss</condition>
  <arm_group>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>IV administration of iron-III-carboxymaltose according to iron deficit every 4 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>IV administration of 1000ml 0.9% NaCl every 4 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Iron Carboxymaltose</intervention_name>
    <description>see above</description>
    <arm_group_label>Group A</arm_group_label>
    <other_name>IRON</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>see above</description>
    <arm_group_label>Group B</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients listed for OLT with positive screening for IDA&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt;18 years&#xD;
&#xD;
          -  Hemochromatosis&#xD;
&#xD;
          -  Iron utilization disorders&#xD;
&#xD;
          -  Non-IDA&#xD;
&#xD;
          -  Therapy with erythropoietin-stimulating agents or intravenous iron within 4 weeks&#xD;
             prior to screening&#xD;
&#xD;
          -  Previous allergic reactions against intravenous iron formulations&#xD;
&#xD;
          -  Transfusion within 2 weeks prior to screening&#xD;
&#xD;
          -  Complete portal vein thrombosis&#xD;
&#xD;
          -  High-urgency OLT&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Sepsis or severe infection&#xD;
&#xD;
          -  Immunosuppressive therapy&#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>Georg P Gyoeri, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Surgery</affiliation>
  </overall_official>
  <overall_official>
    <last_name>David M Baron, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Anaesthesiology</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Georg P Gyoeri, MD</last_name>
    <phone>+43140400</phone>
    <phone_ext>68700</phone_ext>
    <email>georg.gyoeri@meduniwien.ac.at</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Andreas Rosenstingl</last_name>
    <phone>+43140400</phone>
    <phone_ext>68730</phone_ext>
    <email>andreas.rosenstingl@meduniwien.ac.at</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Medical University of Vienna, Department of Surgery</name>
      <address>
        <city>Vienna</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Georg Gyoeri, MD</last_name>
      <phone>+43140400</phone>
      <phone_ext>68700</phone_ext>
      <email>georg.gyoeri@meduniwien.ac.at</email>
    </contact>
    <contact_backup>
      <last_name>Andreas Rosenstingl</last_name>
      <phone>+43140400</phone>
      <phone_ext>68730</phone_ext>
      <email>Andreas.rosenstingl@meduniwien.ac.at</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 14, 2020</study_first_submitted>
  <study_first_submitted_qc>July 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 17, 2020</study_first_posted>
  <last_update_submitted>July 24, 2020</last_update_submitted>
  <last_update_submitted_qc>July 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Vienna</investigator_affiliation>
    <investigator_full_name>Georg Gyoeri</investigator_full_name>
    <investigator_title>Head of Liver Transplantation Outpatient Clinic</investigator_title>
  </responsible_party>
  <keyword>liver</keyword>
  <keyword>anemia</keyword>
  <keyword>transplantation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anemia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Iron</mesh_term>
  </intervention_browse>
  <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/NCT04475887
org study id: 1175/2017
nct id: NCT04475887
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to investigate whether therapy with intravenous iron carboxymaltose
      in patients with iron deficiency anemia (IDA) listed for orthotopic liver transplantation
      (OLT) increases hemoglobin concentrations and reduces intraoperative transfusion of packed
      red blood cells (PRBCs). The investigators hypothesize that therapy with intravenous iron
      will increase hemoglobin concentrations and reduce intraoperative transfusion of PRBCs in
      patients with IDA listed for OLT.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Hemoglobin at OLT
time frame: 6 months
description: Change in hemoglobin concentrations from baseline until before induction of anesthesia for OLT
measure: Transfusion requirement
time frame: 6 months
description: Transfusion of PRBCs during and within the first 24 hours following OLT
measure: Hemoglobin after 4 weeks
time frame: 4 weeks
description: Change in hemoglobin concentrations from baseline until 4 weeks after initiation of therapy
arm group label: Group A
arm group type: Active Comparator
description: IV administration of iron-III-carboxymaltose according to iron deficit every 4 weeks.
arm group label: Group B
arm group type: Placebo Comparator
description: IV administration of 1000ml 0.9% NaCl every 4 weeks.
intervention type: Drug
intervention name: Iron Carboxymaltose
description: see above
arm group label: Group A
other name: IRON
intervention type: Drug
intervention name: Placebo
description: see above
arm group label: Group B
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Georg P Gyoeri, MD
role: Principal Investigator
affiliation: Department of Surgery
last name: David M Baron, MD
role: Principal Investigator
affiliation: Department of Anaesthesiology
last name: Georg P Gyoeri, MD
phone: +43140400
phone ext: 68700
email: georg.gyoeri@meduniwien.ac.at
last name: Andreas Rosenstingl
phone: +43140400
phone ext: 68730
email: andreas.rosenstingl@meduniwien.ac.at
facility: 
status: Recruiting
contact: 
contact backup: 
country: Austria
responsible party type: Principal Investigator
investigator affiliation: Medical University of Vienna
investigator full name: Georg Gyoeri
investigator title: Head of Liver Transplantation Outpatient Clinic
mesh term: Anemia
mesh term: Iron
sharing ipd: No