<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/NCT01676740</url>
  </required_header>
  <id_info>
    <org_study_id>MMCHI0112</org_study_id>
    <nct_id>NCT01676740</nct_id>
  </id_info>
  <brief_title>Iron and Vitamin Adminstration Prior to Joint Replacement to Prevent Transfusion</brief_title>
  <official_title>Randomized Ttrial to Establish the Efficacy of Hematinic Agents in Patietns With Mild Anemia Undergoing Total Hip or Knee Replacement in Avoiding Blood Transfusion</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Meir Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Meir Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To establish the efficacy of screening for anemia and treatment of mild anemia with iron and&#xD;
      vitamins prior to THR and TKR as a means of increasing hemoglobin and reducing perioperative&#xD;
      allogeneic blood transfusion.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with mild anemia will be identified at preoperative clinic visit&#xD;
&#xD;
        -  Patients will be screened for inclusion and exclusion criteria&#xD;
&#xD;
        -  Eligible patients will have laboratory testing performed as follows: CBC, liver and&#xD;
           kidney function tests, serum iron, transferrin, ferritin, serum folic acid, vitamin B12&#xD;
           and C-reactive protein&#xD;
&#xD;
        -  Patients will be assigned to a deficient group or non-deficient group depending upon&#xD;
           laboratory hematinic values&#xD;
&#xD;
        -  Patients in the &quot;non-deficient' group will be randomized using a computer-generated code&#xD;
           to treatment or no treatment&#xD;
&#xD;
        -  Treatment will begin within 2 weeks of laboratory testing and 4-6 weeks prior to&#xD;
           surgery.&#xD;
&#xD;
        -  Hematinic therapy will consist of oral ferric hydrochloride polymaltose 200 mg/d and&#xD;
           folic acid 0.4 mg/d; sublingual vitamin B12 1000 µg three times a week&#xD;
&#xD;
        -  On the day of surgery laboratory testing will be performed as follows: CBC, kidney and&#xD;
           liver function tests, serum iron, transferrin, ferritin, serum folic acid, vitamin B12&#xD;
           and C-reactive protein.&#xD;
&#xD;
        -  The same surgical team in each center will operate on all study patients and will be&#xD;
           blinded to the preoperative hemoglobin&#xD;
&#xD;
        -  Routine postoperative management will be provided as determined by the treating&#xD;
           physicians&#xD;
&#xD;
        -  Blood transfusion will be decided upon by a study physician at each center blinded to&#xD;
           the patients' group assignment and preoperative hemoglobin&#xD;
&#xD;
        -  The primary outcome will be perioperative blood transfusion (from 24 hours prior to&#xD;
           surgery until hospital discharge)&#xD;
&#xD;
        -  Secondary outcomes will be length of hospitalization, postoperative wound infection,&#xD;
           walking ability across room at 30 days&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>November 2012</start_date>
  <completion_date type="Anticipated">February 2014</completion_date>
  <primary_completion_date type="Anticipated">December 2013</primary_completion_date>
  <phase>N/A</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Perioperative blood transfusion</measure>
    <time_frame>1 day prior to surgery until hospital discharge</time_frame>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Excessive Amount of Blood / Fluid Transfusion</condition>
  <arm_group>
    <arm_group_label>Mild anemia, normal hematinics</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Mild anemia, normal iron studies, serum folate and vitamin B12 levels - will receive placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Anemia, normal hematinics</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Mild anemia, deficient iron, folate or vitamin B12 levels Iron supplement will be given</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Deficeicnt hematinics</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Iron supplement will be provided</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Iron Supplement,</intervention_name>
    <description>Pills to be swallowed</description>
    <arm_group_label>Anemia, normal hematinics</arm_group_label>
    <arm_group_label>Deficeicnt hematinics</arm_group_label>
    <other_name>Ferrifol</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Daily administration of active drug or placebo</description>
    <arm_group_label>Mild anemia, normal hematinics</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt; 50 years&#xD;
&#xD;
          -  Ability to provide informed consent&#xD;
&#xD;
          -  Elective THR or TKR&#xD;
&#xD;
          -  Mild anemia: Hematocrit 29-39% in men, 29-36% in women&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Identified cause of anemia excluding hematinic deficiency&#xD;
&#xD;
          -  Known source of blood loss&#xD;
&#xD;
          -  Known coagulopathy&#xD;
&#xD;
          -  Unstable coronary syndrome in the previous 3 months&#xD;
&#xD;
          -  Pathologic fracture, presence of malignancy&#xD;
&#xD;
          -  Repeat THR or TKR&#xD;
&#xD;
          -  Orthopedic trauma within the previous 3 months&#xD;
&#xD;
          -  ASA class ≥ 4&#xD;
&#xD;
          -  Creatinine clearance &lt; 30 ml/min&#xD;
&#xD;
          -  AST/ALT &gt; 2x upper limit of normal&#xD;
&#xD;
          -  Preexisting use of hematinic agents&#xD;
&#xD;
          -  Planned acute normovolemic hemodilution&#xD;
&#xD;
          -  Refusal to receive blood products&#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>Martin H Ellis, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Meir Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Meir Medical Center</name>
      <address>
        <city>Kfar Saba</city>
        <zip>44281</zip>
        <country>Israel</country>
      </address>
    </facility>
    <contact>
      <last_name>Martin H Ellis, MD</last_name>
      <phone>972-9-7471822</phone>
      <email>martinel@clalit.org.il</email>
    </contact>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 29, 2012</study_first_submitted>
  <study_first_submitted_qc>August 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 31, 2012</study_first_posted>
  <last_update_submitted>August 31, 2012</last_update_submitted>
  <last_update_submitted_qc>August 31, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 3, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Meir Medical Center</investigator_affiliation>
    <investigator_full_name>Martin Ellis</investigator_full_name>
    <investigator_title>Head Hematology Institute</investigator_title>
  </responsible_party>
  <keyword>hematinic therapy</keyword>
  <keyword>blood transfusion</keyword>
  <keyword>joint replacement</keyword>
  <!-- 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/NCT01676740
org study id: MMCHI0112
nct id: NCT01676740
lead sponsor: 
has dmc: No
To establish the efficacy of screening for anemia and treatment of mild anemia with iron and
      vitamins prior to THR and TKR as a means of increasing hemoglobin and reducing perioperative
      allogeneic blood transfusion.
Patients with mild anemia will be identified at preoperative clinic visit

        -  Patients will be screened for inclusion and exclusion criteria

        -  Eligible patients will have laboratory testing performed as follows: CBC, liver and
           kidney function tests, serum iron, transferrin, ferritin, serum folic acid, vitamin B12
           and C-reactive protein

        -  Patients will be assigned to a deficient group or non-deficient group depending upon
           laboratory hematinic values

        -  Patients in the "non-deficient' group will be randomized using a computer-generated code
           to treatment or no treatment

        -  Treatment will begin within 2 weeks of laboratory testing and 4-6 weeks prior to
           surgery.

        -  Hematinic therapy will consist of oral ferric hydrochloride polymaltose 200 mg/d and
           folic acid 0.4 mg/d; sublingual vitamin B12 1000 µg three times a week

        -  On the day of surgery laboratory testing will be performed as follows: CBC, kidney and
           liver function tests, serum iron, transferrin, ferritin, serum folic acid, vitamin B12
           and C-reactive protein.

        -  The same surgical team in each center will operate on all study patients and will be
           blinded to the preoperative hemoglobin

        -  Routine postoperative management will be provided as determined by the treating
           physicians

        -  Blood transfusion will be decided upon by a study physician at each center blinded to
           the patients' group assignment and preoperative hemoglobin

        -  The primary outcome will be perioperative blood transfusion (from 24 hours prior to
           surgery until hospital discharge)

        -  Secondary outcomes will be length of hospitalization, postoperative wound infection,
           walking ability across room at 30 days
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Perioperative blood transfusion
time frame: 1 day prior to surgery until hospital discharge
arm group label: Mild anemia, normal hematinics
arm group type: Placebo Comparator
description: Mild anemia, normal iron studies, serum folate and vitamin B12 levels - will receive placebo
arm group label: Anemia, normal hematinics
arm group type: Experimental
description: Mild anemia, deficient iron, folate or vitamin B12 levels Iron supplement will be given
arm group label: Deficeicnt hematinics
arm group type: Other
description: Iron supplement will be provided
intervention type: Drug
intervention name: Iron Supplement,
description: Pills to be swallowed
arm group label: Anemia, normal hematinics
arm group label: Deficeicnt hematinics
other name: Ferrifol
intervention type: Drug
intervention name: Placebo
description: Daily administration of active drug or placebo
arm group label: Mild anemia, normal hematinics
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Martin H Ellis, MD
role: Principal Investigator
affiliation: Meir Medical Center
facility: 
contact: 
country: Israel
responsible party type: Principal Investigator
investigator affiliation: Meir Medical Center
investigator full name: Martin Ellis
investigator title: Head Hematology Institute