<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/NCT02973074</url>
  </required_header>
  <id_info>
    <org_study_id>C-124-16</org_study_id>
    <nct_id>NCT02973074</nct_id>
  </id_info>
  <brief_title>Oral Iron Substitution for Orthopedic Surgery</brief_title>
  <official_title>Pilot Study for Investigation of the Feasibility and for Optimization of Oral Iron Substitution in the Course of Patient Blood Management for Orthopedic Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kepler University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kepler University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this pilot study is to investigate an 4 weeks period of oral iron substitution in&#xD;
      the course of Patient Blood Management in preparation for orthopedic surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patient blood management (PBM) is a clinical multidisciplinary, patient orientated concept&#xD;
      for treatment of anaemia, reduction of intraoperative blood loss and increasing anaemic&#xD;
      tolerance.&#xD;
&#xD;
      In the Kepler University Hospital (former General Hospital Linz) PBM was introduced in 2006.&#xD;
      Since then patients for elective orthopedic surgery (knee an hip replacement) are screened&#xD;
      for iron deficiency anaemia and if needed treated with the more effective intravenous iron.&#xD;
&#xD;
      Oral iron medications are not as efficient (low bioavailability, more side effects) as the&#xD;
      intravenous iron infusion. Although there is risk of anaphylactoid reactions.&#xD;
&#xD;
      In this study the new oral iron supplement OLEOvital Eisen forte (available in Austria) ist&#xD;
      tested on its effectivity for treatment of iron deficiency in the course of PBM.&#xD;
&#xD;
      It has a much more higher bioavailability without the typically side effects of the routinely&#xD;
      used oral iron medications.&#xD;
&#xD;
      Within this study the investigators want to examine the feasibility of this iron substitution&#xD;
      concept OLEOvital and its efficacy. Also the investigators want to get pilot data for a&#xD;
      further randomized controlled trial.&#xD;
&#xD;
      The increase of the hemoglobin level in 4 weeks of minimum 1g/dl is going to be expected and&#xD;
      monitored.&#xD;
&#xD;
      For comparison of the new oral substitution concept OLEOvital with the standard intravenous&#xD;
      iron substitution an historic control group is going to be used.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    no enough partícipants enrolled in the 1 year planned for recruitment&#xD;
  </why_stopped>
  <start_date>November 25, 2016</start_date>
  <completion_date type="Actual">November 1, 2017</completion_date>
  <primary_completion_date type="Actual">November 1, 2017</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>increase of hemoglobin level</measure>
    <time_frame>4 weeks</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Iron Deficiency Anemia</condition>
  <arm_group>
    <arm_group_label>OLEOvital</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>30mg iron are being administered orally twice a day for a period of 4 Weeks it is a granulated powder which is taken orally and then solved with saliva, without taking water</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>OLEOvital</intervention_name>
    <description>2sachets with 30mg iron per day for a 4 weeks period</description>
    <arm_group_label>OLEOvital</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age over 55 years&#xD;
&#xD;
          -  indication for patient blood management for elective orthopedic surgery&#xD;
&#xD;
          -  listed for a orthopedic surgery (e.g. hip or knee replacement) 5-7 weeks after begin&#xD;
             of patient blood management&#xD;
&#xD;
          -  Haemoglobin male &lt; 12-13g/dl, female &lt;11-12g/dl&#xD;
&#xD;
          -  written informed consent after written and verbal information&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  indication for treatment with erythropoietin&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  nursing period&#xD;
&#xD;
          -  diarrhea or tendency to diarrhea&#xD;
&#xD;
          -  fructose intolerance&#xD;
&#xD;
          -  pre - menopause&#xD;
&#xD;
          -  permanent or expected blood loss&#xD;
&#xD;
          -  participation in other study&#xD;
&#xD;
          -  expected compliance problems&#xD;
&#xD;
          -  legal incapacity&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jens Meier, Prof. Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kepler University Hospital Linz, Clinic for Anesthesiology and intensive care medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kepler University Hospital</name>
      <address>
        <city>Linz</city>
        <zip>4020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <reference>
    <citation>Gombotz H, Rehak PH, Shander A, Hofmann A. Blood use in elective surgery: the Austrian benchmark study. Transfusion. 2007 Aug;47(8):1468-80. doi: 10.1111/j.1537-2995.2007.01286.x.</citation>
    <PMID>17655591</PMID>
  </reference>
  <reference>
    <citation>Seicean A, Alan N, Seicean S, Neuhauser D, Weil RJ. The effect of blood transfusion on short-term, perioperative outcomes in elective spine surgery. J Clin Neurosci. 2014 Sep;21(9):1579-85. doi: 10.1016/j.jocn.2014.03.003. Epub 2014 May 19.</citation>
    <PMID>24852902</PMID>
  </reference>
  <reference>
    <citation>Danninger T, Rasul R, Poeran J, Stundner O, Mazumdar M, Fleischut PM, Poultsides L, Memtsoudis SG. Blood transfusions in total hip and knee arthroplasty: an analysis of outcomes. ScientificWorldJournal. 2014 Jan 21;2014:623460. doi: 10.1155/2014/623460. eCollection 2014.</citation>
    <PMID>24587736</PMID>
  </reference>
  <reference>
    <citation>Meybohm P, Richards T, Isbister J, Hofmann A, Shander A, Goodnough LT, Munoz M, Gombotz H, Weber CF, Choorapoikayil S, Spahn DR, Zacharowski K. Patient Blood Management Bundles to Facilitate Implementation. Transfus Med Rev. 2017 Jan;31(1):62-71. doi: 10.1016/j.tmrv.2016.05.012. Epub 2016 May 28.</citation>
    <PMID>27317382</PMID>
  </reference>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>November 22, 2016</study_first_submitted>
  <study_first_submitted_qc>November 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 25, 2016</study_first_posted>
  <last_update_submitted>August 7, 2018</last_update_submitted>
  <last_update_submitted_qc>August 7, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 9, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kepler University Hospital</investigator_affiliation>
    <investigator_full_name>Nina Pauker, MD</investigator_full_name>
    <investigator_title>Dr. med. univ.</investigator_title>
  </responsible_party>
  <keyword>iron deficiency</keyword>
  <keyword>patient blood management</keyword>
  <keyword>anemia</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>
  <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/NCT02973074
org study id: C-124-16
nct id: NCT02973074
lead sponsor: 
has dmc: No
The aim of this pilot study is to investigate an 4 weeks period of oral iron substitution in
      the course of Patient Blood Management in preparation for orthopedic surgery.
Patient blood management (PBM) is a clinical multidisciplinary, patient orientated concept
      for treatment of anaemia, reduction of intraoperative blood loss and increasing anaemic
      tolerance.

      In the Kepler University Hospital (former General Hospital Linz) PBM was introduced in 2006.
      Since then patients for elective orthopedic surgery (knee an hip replacement) are screened
      for iron deficiency anaemia and if needed treated with the more effective intravenous iron.

      Oral iron medications are not as efficient (low bioavailability, more side effects) as the
      intravenous iron infusion. Although there is risk of anaphylactoid reactions.

      In this study the new oral iron supplement OLEOvital Eisen forte (available in Austria) ist
      tested on its effectivity for treatment of iron deficiency in the course of PBM.

      It has a much more higher bioavailability without the typically side effects of the routinely
      used oral iron medications.

      Within this study the investigators want to examine the feasibility of this iron substitution
      concept OLEOvital and its efficacy. Also the investigators want to get pilot data for a
      further randomized controlled trial.

      The increase of the hemoglobin level in 4 weeks of minimum 1g/dl is going to be expected and
      monitored.

      For comparison of the new oral substitution concept OLEOvital with the standard intravenous
      iron substitution an historic control group is going to be used.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: increase of hemoglobin level
time frame: 4 weeks
arm group label: OLEOvital
arm group type: Other
description: 30mg iron are being administered orally twice a day for a period of 4 Weeks it is a granulated powder which is taken orally and then solved with saliva, without taking water
intervention type: Dietary Supplement
intervention name: OLEOvital
description: 2sachets with 30mg iron per day for a 4 weeks period
arm group label: OLEOvital
criteria: 
gender: All
minimum age: 55 Years
maximum age: N/A
healthy volunteers: No
last name: Jens Meier, Prof. Dr.
role: Principal Investigator
affiliation: Kepler University Hospital Linz, Clinic for Anesthesiology and intensive care medicine
facility: 
country: Austria
citation: Gombotz H, Rehak PH, Shander A, Hofmann A. Blood use in elective surgery: the Austrian benchmark study. Transfusion. 2007 Aug;47(8):1468-80. doi: 10.1111/j.1537-2995.2007.01286.x.
PMID: 17655591
citation: Seicean A, Alan N, Seicean S, Neuhauser D, Weil RJ. The effect of blood transfusion on short-term, perioperative outcomes in elective spine surgery. J Clin Neurosci. 2014 Sep;21(9):1579-85. doi: 10.1016/j.jocn.2014.03.003. Epub 2014 May 19.
PMID: 24852902
citation: Danninger T, Rasul R, Poeran J, Stundner O, Mazumdar M, Fleischut PM, Poultsides L, Memtsoudis SG. Blood transfusions in total hip and knee arthroplasty: an analysis of outcomes. ScientificWorldJournal. 2014 Jan 21;2014:623460. doi: 10.1155/2014/623460. eCollection 2014.
PMID: 24587736
citation: Meybohm P, Richards T, Isbister J, Hofmann A, Shander A, Goodnough LT, Munoz M, Gombotz H, Weber CF, Choorapoikayil S, Spahn DR, Zacharowski K. Patient Blood Management Bundles to Facilitate Implementation. Transfus Med Rev. 2017 Jan;31(1):62-71. doi: 10.1016/j.tmrv.2016.05.012. Epub 2016 May 28.
PMID: 27317382
responsible party type: Principal Investigator
investigator affiliation: Kepler University Hospital
investigator full name: Nina Pauker, MD
investigator title: Dr. med. univ.
mesh term: Anemia, Iron-Deficiency
mesh term: Iron Deficiencies
sharing ipd: No