<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/NCT02210949</url>
  </required_header>
  <id_info>
    <org_study_id>EPICSCZE14</org_study_id>
    <nct_id>NCT02210949</nct_id>
  </id_info>
  <brief_title>Pre-operative Treatment With Erythropoietin and Iron Supplement in Cardiac Surgery</brief_title>
  <official_title>Pre-operative Treatment With Erythropoietin and Iron Supplement for Prevention of Perioperative Blood Transfusion in Cardiac Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Catharina Ziekenhuis Eindhoven</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Catharina Ziekenhuis Eindhoven</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Pre-treatment of patients with erythropoietin subcutaneously and iron supplement&#xD;
      intravenously, in order to create a clinical pathway to minimize transfusion of red blood&#xD;
      cells in a selected group of cardiac patients with an increased risk for blood transfusions&#xD;
      in our cardiac surgery program.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Blood transfusion is identified as an independent predictor of early mortality after Coronary&#xD;
      artery bypass grafting operations In addition, female gender, lower body surface area (BSA),&#xD;
      low preoperative Hemoglobin (Hb), previous cardiac surgery, emergency operation and low&#xD;
      preoperative creatinin clearance were found to be independent risk factors for receiving Red&#xD;
      Blood Cells (RBC) units.&#xD;
&#xD;
      We create a clinical pathway to reduce transfusion of red blood cells by pretreating patients&#xD;
      with erythropoietin and iron to determine the reduction of number of patients who receive&#xD;
      blood transfusion perioperatively. Also we want to investigate the decrease in the mean&#xD;
      number of RBC units received per patient in the perioperative period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Low inclusion rate&#xD;
  </why_stopped>
  <start_date type="Actual">August 2014</start_date>
  <completion_date type="Actual">April 2017</completion_date>
  <primary_completion_date type="Actual">April 2017</primary_completion_date>
  <phase>Phase 4</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The number of patients who receive RBC transfusion perioperatively</measure>
    <time_frame>1 day</time_frame>
    <description>To determine the reduction of the number of patients receiving blood transfusion the pre-treated group with erythropoietin and iron supplement compared to the control patients.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The number of patients who receive RBC transfusion perioperatively</measure>
    <time_frame>3 days</time_frame>
    <description>To determine the reduction of the number of patients receiving blood transfusion the pre-treated group with erythropoietin and iron supplement compared to the control patients.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The number of patients who receive RBC transfusion perioperatively</measure>
    <time_frame>30 days</time_frame>
    <description>To determine the reduction of the number of patients receiving blood transfusion the pre-treated group with erythropoietin and iron supplement compared to the control patients.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To determine the degree of reduction in the mean number of RBC unit transfusions per patient.</measure>
    <time_frame>30 days</time_frame>
    <description>In order to determine the degree of reduction in the mean number of RBC unit transfusions per patient. We count the units we need to give compared to the control group according to standard accepted postoperative levels Hb in our Hospital.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Other general non specific outcome data after cardiac surgery</measure>
    <time_frame>30 days</time_frame>
    <description>Moreover, early mortality and morbidity (postoperative blood loss, presence of myocardial infarction, Cerebral vascular accident (CVA), renal function disturbances) are always collected in the computerized database of the department of Cardiothoracic Surgery. These parameters will be used in the present study as well.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">7</enrollment>
  <condition>Heart; Dysfunction Postoperative, Cardiac Surgery</condition>
  <condition>Anemia, Iron-Deficiency</condition>
  <arm_group>
    <arm_group_label>Erythropoietin Iron</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Erythropoietin and iron:&#xD;
Administration of Erythropoietin (600 IU/kg (14.4 g/L)) twice weekly for three weeks .&#xD;
Administration of Iron (Ferinject (iron(III)carboxymaltose)) intravenously 1000 mg once.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Erythropoietin subcutaneously and Iron intravenously</intervention_name>
    <description>Administration of Erythropoietin subcutaneously and administration of iron intravenously</description>
    <arm_group_label>Erythropoietin Iron</arm_group_label>
    <other_name>Eprex</other_name>
    <other_name>Ferinject</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Undergoing isolated Coronary Artery Bypass Grafting operation or Aortic Valve Repair&#xD;
             (AVR).&#xD;
&#xD;
          2. Preoperative Hb &lt; 7 mmol/l.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Off pump surgery.&#xD;
&#xD;
          2. Combination surgery.&#xD;
&#xD;
          3. Re-operation.&#xD;
&#xD;
          4. Emergency operation.&#xD;
&#xD;
          5. Patients with bleeding disturbances; e.g, hemophilia and patients with chronic liver&#xD;
             disease.&#xD;
&#xD;
          6. Concomitant use of cyclosporine prior to, during or following surgery.&#xD;
&#xD;
          7. Female patients who are pregnant or planning to become pregnant.&#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>Marius C Haanschoten, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Catharina Ziekenhuis Eindhoven the Netherlands</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Catharina Hospital</name>
      <address>
        <city>Eindhoven</city>
        <state>N Brabant</state>
        <zip>5602 ZA</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <reference>
    <citation>van Straten AH, Kats S, Bekker MW, Verstappen F, ter Woorst JF, van Zundert AJ, Soliman Hamad MA. Risk factors for red blood cell transfusion after coronary artery bypass graft surgery. J Cardiothorac Vasc Anesth. 2010 Jun;24(3):413-7. doi: 10.1053/j.jvca.2010.01.001. Epub 2010 Mar 15.</citation>
    <PMID>20231104</PMID>
  </reference>
  <reference>
    <citation>Alghamdi AA, Albanna MJ, Guru V, Brister SJ. Does the use of erythropoietin reduce the risk of exposure to allogeneic blood transfusion in cardiac surgery? A systematic review and meta-analysis. J Card Surg. 2006 May-Jun;21(3):320-6. doi: 10.1111/j.1540-8191.2006.00241.x.</citation>
    <PMID>16684074</PMID>
  </reference>
  <reference>
    <citation>van Straten AH, Bekker MW, Soliman Hamad MA, van Zundert AA, Martens EJ, Schonberger JP, de Wolf AM. Transfusion of red blood cells: the impact on short-term and long-term survival after coronary artery bypass grafting, a ten-year follow-up. Interact Cardiovasc Thorac Surg. 2010 Jan;10(1):37-42. doi: 10.1510/icvts.2009.214551. Epub 2009 Oct 8.</citation>
    <PMID>19815567</PMID>
  </reference>
  <reference>
    <citation>Fox A. Recombinant human erythropoeitin: efficacy and safety considerations for maximizing blood conservation in cardiac surgery. Anesthesiology. 2011 Nov;115(5):912-4. doi: 10.1097/ALN.0b013e318231fd85. No abstract available.</citation>
    <PMID>22027621</PMID>
  </reference>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>June 23, 2014</study_first_submitted>
  <study_first_submitted_qc>August 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 7, 2014</study_first_posted>
  <last_update_submitted>April 4, 2017</last_update_submitted>
  <last_update_submitted_qc>April 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 5, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Catharina Ziekenhuis Eindhoven</investigator_affiliation>
    <investigator_full_name>AHM van Straten</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <keyword>Blood transfusion</keyword>
  <keyword>Erythropoietin</keyword>
  <keyword>Iron suppletion</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anemia, Iron-Deficiency</mesh_term>
    <mesh_term>Iron Deficiencies</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Epoetin Alfa</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/NCT02210949
org study id: EPICSCZE14
nct id: NCT02210949
lead sponsor: 
has dmc: No
Pre-treatment of patients with erythropoietin subcutaneously and iron supplement
      intravenously, in order to create a clinical pathway to minimize transfusion of red blood
      cells in a selected group of cardiac patients with an increased risk for blood transfusions
      in our cardiac surgery program.
Blood transfusion is identified as an independent predictor of early mortality after Coronary
      artery bypass grafting operations In addition, female gender, lower body surface area (BSA),
      low preoperative Hemoglobin (Hb), previous cardiac surgery, emergency operation and low
      preoperative creatinin clearance were found to be independent risk factors for receiving Red
      Blood Cells (RBC) units.

      We create a clinical pathway to reduce transfusion of red blood cells by pretreating patients
      with erythropoietin and iron to determine the reduction of number of patients who receive
      blood transfusion perioperatively. Also we want to investigate the decrease in the mean
      number of RBC units received per patient in the perioperative period.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: The number of patients who receive RBC transfusion perioperatively
time frame: 1 day
description: To determine the reduction of the number of patients receiving blood transfusion the pre-treated group with erythropoietin and iron supplement compared to the control patients.
measure: The number of patients who receive RBC transfusion perioperatively
time frame: 3 days
description: To determine the reduction of the number of patients receiving blood transfusion the pre-treated group with erythropoietin and iron supplement compared to the control patients.
measure: The number of patients who receive RBC transfusion perioperatively
time frame: 30 days
description: To determine the reduction of the number of patients receiving blood transfusion the pre-treated group with erythropoietin and iron supplement compared to the control patients.
measure: To determine the degree of reduction in the mean number of RBC unit transfusions per patient.
time frame: 30 days
description: In order to determine the degree of reduction in the mean number of RBC unit transfusions per patient. We count the units we need to give compared to the control group according to standard accepted postoperative levels Hb in our Hospital.
measure: Other general non specific outcome data after cardiac surgery
time frame: 30 days
description: Moreover, early mortality and morbidity (postoperative blood loss, presence of myocardial infarction, Cerebral vascular accident (CVA), renal function disturbances) are always collected in the computerized database of the department of Cardiothoracic Surgery. These parameters will be used in the present study as well.
arm group label: Erythropoietin Iron
arm group type: Other
description: Erythropoietin and iron:
Administration of Erythropoietin (600 IU/kg (14.4 g/L)) twice weekly for three weeks .
Administration of Iron (Ferinject (iron(III)carboxymaltose)) intravenously 1000 mg once.
intervention type: Drug
intervention name: Erythropoietin subcutaneously and Iron intravenously
description: Administration of Erythropoietin subcutaneously and administration of iron intravenously
arm group label: Erythropoietin Iron
other name: Eprex
other name: Ferinject
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Marius C Haanschoten, MD
role: Principal Investigator
affiliation: Catharina Ziekenhuis Eindhoven the Netherlands
facility: 
country: Netherlands
citation: van Straten AH, Kats S, Bekker MW, Verstappen F, ter Woorst JF, van Zundert AJ, Soliman Hamad MA. Risk factors for red blood cell transfusion after coronary artery bypass graft surgery. J Cardiothorac Vasc Anesth. 2010 Jun;24(3):413-7. doi: 10.1053/j.jvca.2010.01.001. Epub 2010 Mar 15.
PMID: 20231104
citation: Alghamdi AA, Albanna MJ, Guru V, Brister SJ. Does the use of erythropoietin reduce the risk of exposure to allogeneic blood transfusion in cardiac surgery? A systematic review and meta-analysis. J Card Surg. 2006 May-Jun;21(3):320-6. doi: 10.1111/j.1540-8191.2006.00241.x.
PMID: 16684074
citation: van Straten AH, Bekker MW, Soliman Hamad MA, van Zundert AA, Martens EJ, Schonberger JP, de Wolf AM. Transfusion of red blood cells: the impact on short-term and long-term survival after coronary artery bypass grafting, a ten-year follow-up. Interact Cardiovasc Thorac Surg. 2010 Jan;10(1):37-42. doi: 10.1510/icvts.2009.214551. Epub 2009 Oct 8.
PMID: 19815567
citation: Fox A. Recombinant human erythropoeitin: efficacy and safety considerations for maximizing blood conservation in cardiac surgery. Anesthesiology. 2011 Nov;115(5):912-4. doi: 10.1097/ALN.0b013e318231fd85. No abstract available.
PMID: 22027621
responsible party type: Principal Investigator
investigator affiliation: Catharina Ziekenhuis Eindhoven
investigator full name: AHM van Straten
investigator title: MD, PhD
mesh term: Anemia, Iron-Deficiency
mesh term: Iron Deficiencies
mesh term: Epoetin Alfa