<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/NCT02999217</url>
  </required_header>
  <id_info>
    <org_study_id>BEC-MF-74</org_study_id>
    <nct_id>NCT02999217</nct_id>
  </id_info>
  <brief_title>Intravenous Iron for Correction of Anaemia After Colorectal Surgery</brief_title>
  <official_title>The Impact of Treatment of Anaemia With Intravenous Iron on Haematological Values for Patients After Colorectal Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kaunas University of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Orivas, Lithuania</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Pharmacosmos A/S</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Kaunas University of Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This 4-week prospective double blind anaemia management study evaluates the effect of&#xD;
      high-dose postoperative intravenous iron vs placebo for patients after colorectal cancer&#xD;
      surgery. Patients with preoperative levels of haemoglobin 90-120 g/l will be randomly&#xD;
      assigned to receive either 1 g of intravenous iron or equal amount of saline postoperatively.&#xD;
      Comparison will be based on the levels of haemoglobin, ferritin and other haematological&#xD;
      parameters over time and profile of clinical recovery.&#xD;
&#xD;
      The primary end point is that iron isomaltoside given postoperatively is superior to placebo&#xD;
      in terms of increase and stability of levels of haemoglobin and other haematological&#xD;
      parameters.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Aim: to assess the effect of treatment of preoperative anaemia with intravenous iron on&#xD;
      haematological parameters for patients after elective colorectal surgery.&#xD;
&#xD;
      Primary Hypothesis: postoperative treatment with intravenous iron increases the levels of&#xD;
      haemoglobin, ferritin, red cell count and is superior compared to placebo.&#xD;
&#xD;
      Secondary effects: treatment with intravenous iron vs placebo provides reduction of blood&#xD;
      transfusions, postoperative complications and hospital stay.&#xD;
&#xD;
      The Objectives:&#xD;
&#xD;
        1. To estimate the rate of preoperative anaemia in patients of elective colorectal surgery.&#xD;
&#xD;
        2. To assess the dynamic changes of total blood count values in colorectal surgery patients&#xD;
           treated with postoperative intravenous iron.&#xD;
&#xD;
        3. To compare the changes in total blood count values over time in colorectal surgery&#xD;
           patients treated with intravenous iron versus colorectal surgery patients of the control&#xD;
           group.&#xD;
&#xD;
      Methods:&#xD;
&#xD;
      The prospective, double-blinded study includes American Society of Anaesthesiology (ASA)&#xD;
      I-III patients, aged 18-75 years, admitted for elective colorectal surgery. Preoperatively,&#xD;
      patients with levels of haemoglobin 90-120 g/l will be identified and their serum ferritin&#xD;
      will be tested. In cases of ferritin&lt;100 mkg/l, patients will be blindly randomized into one&#xD;
      of the two groups: treatment group (group T) is given 1000 mg of intravenous iron (iron&#xD;
      isomaltoside, Orivas, Pharmacosmos) in the postoperative recovery ward and control group&#xD;
      (group C) which is given the same volume of intravenous saline (placebo).&#xD;
&#xD;
      Patients in both groups will be provided with general anaesthesia (fentanyl, propofol,&#xD;
      atracurium, inhaled sevoflurane for maintenance) and after tracheal extubation will be&#xD;
      transferred to the recovery ward.&#xD;
&#xD;
      Patient blood tests: total blood count, haemoglobin, haematocrit, mean corpuscular volume&#xD;
      (MCV), mean corpuscular haemoglobin (MCH), plasma ferritin) will be assessed in both groups 1&#xD;
      day preoperatively, day 1 and 3 postoperatively, the day of discharge and 4 weeks after&#xD;
      discharge from the department of surgery. The level of reticulocyte and reticulocyte&#xD;
      haemoglobin concentration will be determined on the day of discharge and 4 weeks after&#xD;
      discharge.&#xD;
&#xD;
      According to the study protocol, groups will also be compared in terms of clinical recovery,&#xD;
      requirements of intravenous fluids and blood transfusion and duration of hospital stay.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2016</start_date>
  <completion_date type="Anticipated">October 2018</completion_date>
  <primary_completion_date type="Anticipated">October 2017</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>Changes in haemoglobin level</measure>
    <time_frame>4 weeks after surgery</time_frame>
    <description>Haemoglobin level will be tested in both groups at day 1, 3 postoperatively, day of discharge and 4 weeks after surgery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes of plasma ferritin</measure>
    <time_frame>4 weeks after surgery</time_frame>
    <description>Other haematological variables will be tested in both groups at day 1, 3 postoperatively, day of discharge and 4 weeks after surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of red blood cell count</measure>
    <time_frame>4 weeks after surgery</time_frame>
    <description>Other haematological variables will be tested in both groups at day 1, 3 postoperatively, day of discharge and 4 weeks after surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of mean corpuscular volume</measure>
    <time_frame>4 weeks after surgery</time_frame>
    <description>Other haematological variables will be tested in both groups at day 1, 3 postoperatively, day of discharge and 4 weeks after surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of mean corpuscular haemoglobin concentration</measure>
    <time_frame>4 weeks after surgery</time_frame>
    <description>Other haematological variables will be tested in both groups at day 1, 3 postoperatively, day of discharge and 4 weeks after surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of reticulocyte count</measure>
    <time_frame>4 weeks after surgery</time_frame>
    <description>It will be tested in both groups at the day of discharge and 4 weeks after surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of reticulocyte haemoglobin count</measure>
    <time_frame>4 weeks after surgery</time_frame>
    <description>It will be tested in both groups at the day of discharge and 4 weeks after surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of blood transfusion</measure>
    <time_frame>From date of randomization until the day of discharge from the hospital, up to 2 weeks after surgery</time_frame>
    <description>Total amount of blood transfusion units will be counted 2 weeks after surgery in both groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amount of intravenous fluid therapy</measure>
    <time_frame>From date of randomization until the day of discharge, up to 2 weeks after surgery</time_frame>
    <description>Total amount of intravenous fluids will be counted starting from the date of randomization, separately in the operating room, recovery area and each day postoperatively until 2 weeks after surgery in both groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with perioperative complications</measure>
    <time_frame>4 weeks after surgery</time_frame>
    <description>Total number of postoperative complications will be counted in both groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of hospital stay</measure>
    <time_frame>From the date of randomization until the day of discharge, up to 2 weeks after surgery</time_frame>
    <description>It will be counted in both groups 2 weeks after surgery in both groups.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Anemia, Iron-Deficiency</condition>
  <condition>Intravenous Drug Usage</condition>
  <condition>Colorectal Neoplasms</condition>
  <condition>Colorectal Surgery</condition>
  <arm_group>
    <arm_group_label>Treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>1 g of intravenous iron isomaltoside given postoperatively for patients with preoperative anaemia (Hb 90-120 g/l and plasma ferritin&lt;100 mkg/l).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The same amount of intravenous saline for patients with preoperative anaemia (Hb 90-120 g/l and plasma ferritin&lt;100 mkg/l).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Iron isomaltoside</intervention_name>
    <description>Intravenous injection 1 g given postoperatively in the recovery ward.&#xD;
Blood tests including red blood cell count, plasma ferritin, haemoglobin, haematocrit, mean corpuscular volume, mean haemoglobin concentration are made 1 day preoperatively, day 1, day 3 postoperatively, day of discharge and 1 month after discharge.&#xD;
Reticulocyte count and reticulocyte haemoglobin concentration tests are made on the day of discharge and 1 month after discharge.&#xD;
Count of total consumption of intravenous blood products. Count of total intravenous fluids. Clinical recovery and complications. Duration of hospital stay.</description>
    <arm_group_label>Treatment</arm_group_label>
    <other_name>Monofer</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Saline</intervention_name>
    <description>Intravenous injection given postoperatively in the recovery ward.&#xD;
Blood tests including red blood cell count, plasma ferritin, haemoglobin, haematocrit, mean corpuscular volume, mean haemoglobin concentration are made 1 day preoperatively, day 1, day 3 postoperatively, day of discharge and 1 month after discharge.&#xD;
Reticulocyte count and reticulocyte haemoglobin concentration tests are made on the day of discharge and 1 month after discharge.&#xD;
Count of total consumption of intravenous blood products. Count of total intravenous fluids. Clinical recovery and complications. Duration of hospital stay.</description>
    <arm_group_label>Control</arm_group_label>
    <other_name>Sodium chloride</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  elective colorectal cancer surgery&#xD;
&#xD;
          -  preoperative haemoglobin 90-120 g/l&#xD;
&#xD;
          -  preoperative plasma ferritin &lt;100 mkg/l&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  laparoscopic colorectal surgery&#xD;
&#xD;
          -  body mass &lt;50kg&#xD;
&#xD;
          -  history of overdosage of iron products&#xD;
&#xD;
          -  family history of haemochromatosis, thalassaemia,&#xD;
&#xD;
          -  non-iron deficiency anaemia (Vit. B12, folic acid defficiency, haemoglobinopathies)&#xD;
&#xD;
          -  under treatment with erythropoietin, intravenous iron or blood transfusion in the last&#xD;
             12 weeks&#xD;
&#xD;
          -  allergy to iron carboxymaltose or its supplements&#xD;
&#xD;
          -  body temperature &gt; 37.5 °C or under antibiotic use&#xD;
&#xD;
          -  chronic liver diseases or/and increased levels of alanine aminotransferase (ALT) or&#xD;
             aspartate aminotransferase (AST) 3 times over normal upper limit&#xD;
&#xD;
          -  patients ill with grave bronchial asthma&#xD;
&#xD;
          -  patients with manifestation of allergy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andrius Macas, MDPhDProf</last_name>
    <role>Study Chair</role>
    <affiliation>Head of the Department of Anaesthesiology, Medical academy, Lithuanian University of Health Sciences</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jurate Gudaityte, MDPhDAssProf</last_name>
    <phone>+37069808531</phone>
    <email>jurate.gudaityte@kaunoklinikos.lt</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Andrius Macas, MDPhDProf</last_name>
    <phone>+37068639123</phone>
    <email>andrius.macas@kaunoklinikos.lt</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Department of Anaesthesiology, Lithuanian University of Health Sciences</name>
      <address>
        <city>Kaunas</city>
        <zip>LT50009</zip>
        <country>Lithuania</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jurate Gudaityte, MDPhDAssProf</last_name>
      <phone>+37069808531</phone>
      <email>jurate.gudaityte@kaunoklinikos.lt</email>
    </contact>
    <contact_backup>
      <last_name>Andrius Macas, MDPhDProf</last_name>
      <phone>+37068639123</phone>
      <email>andrius.macas@kaunoklinikos.lt</email>
    </contact_backup>
    <investigator>
      <last_name>Ruta Paskauskaite, student</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Lithuania</country>
  </location_countries>
  <reference>
    <citation>Shander A, Knight K, Thurer R, Adamson J, Spence R. Prevalence and outcomes of anemia in surgery: a systematic review of the literature. Am J Med. 2004 Apr 5;116 Suppl 7A:58S-69S. doi: 10.1016/j.amjmed.2003.12.013.</citation>
    <PMID>15050887</PMID>
  </reference>
  <reference>
    <citation>Edna TH, Karlsen V, Jullumstro E, Lydersen S. Prevalence of anaemia at diagnosis of colorectal cancer: assessment of associated risk factors. Hepatogastroenterology. 2012 May;59(115):713-6. doi: 10.5754/hge11479.</citation>
    <PMID>22469713</PMID>
  </reference>
  <reference>
    <citation>Ward DG, Roberts K, Brookes MJ, Joy H, Martin A, Ismail T, Spychal R, Iqbal T, Tselepis C. Increased hepcidin expression in colorectal carcinogenesis. World J Gastroenterol. 2008 Mar 7;14(9):1339-45. doi: 10.3748/wjg.14.1339.</citation>
    <PMID>18322945</PMID>
  </reference>
  <reference>
    <citation>Ganz T. Hepcidin and iron regulation, 10 years later. Blood. 2011 Apr 28;117(17):4425-33. doi: 10.1182/blood-2011-01-258467. Epub 2011 Feb 23.</citation>
    <PMID>21346250</PMID>
  </reference>
  <reference>
    <citation>Leichtle SW, Mouawad NJ, Lampman R, Singal B, Cleary RK. Does preoperative anemia adversely affect colon and rectal surgery outcomes? J Am Coll Surg. 2011 Feb;212(2):187-94. doi: 10.1016/j.jamcollsurg.2010.09.013.</citation>
    <PMID>21276532</PMID>
  </reference>
  <reference>
    <citation>Cladellas M, Bruguera J, Comin J, Vila J, de Jaime E, Marti J, Gomez M. Is pre-operative anaemia a risk marker for in-hospital mortality and morbidity after valve replacement? Eur Heart J. 2006 May;27(9):1093-9. doi: 10.1093/eurheartj/ehi830. Epub 2006 Mar 14.</citation>
    <PMID>16537556</PMID>
  </reference>
  <reference>
    <citation>Hogan M, Klein AA, Richards T. The impact of anaemia and intravenous iron replacement therapy on outcomes in cardiac surgery. Eur J Cardiothorac Surg. 2015 Feb;47(2):218-26. doi: 10.1093/ejcts/ezu200. Epub 2014 May 13.</citation>
    <PMID>24824650</PMID>
  </reference>
  <reference>
    <citation>Elhenawy AM, Meyer SR, Bagshaw SM, MacArthur RG, Carroll LJ. Role of preoperative intravenous iron therapy to correct anemia before major surgery: study protocol for systematic review and meta-analysis. Syst Rev. 2015 Mar 15;4:29. doi: 10.1186/s13643-015-0016-4.</citation>
    <PMID>25874460</PMID>
  </reference>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>October 27, 2016</study_first_submitted>
  <study_first_submitted_qc>December 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 21, 2016</study_first_posted>
  <last_update_submitted>December 16, 2016</last_update_submitted>
  <last_update_submitted_qc>December 16, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 21, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>iron isomaltoside</keyword>
  <keyword>plasma ferritin</keyword>
  <keyword>haemoglobin</keyword>
  <keyword>colorectal cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal Neoplasms</mesh_term>
    <mesh_term>Anemia</mesh_term>
    <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>Iron isomaltoside 1000</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>De-identified individual participant data for all primary and secondary outcome measures will be made available within 6 months of study completion.</ipd_description>
  </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/NCT02999217
org study id: BEC-MF-74
nct id: NCT02999217
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
This 4-week prospective double blind anaemia management study evaluates the effect of
      high-dose postoperative intravenous iron vs placebo for patients after colorectal cancer
      surgery. Patients with preoperative levels of haemoglobin 90-120 g/l will be randomly
      assigned to receive either 1 g of intravenous iron or equal amount of saline postoperatively.
      Comparison will be based on the levels of haemoglobin, ferritin and other haematological
      parameters over time and profile of clinical recovery.

      The primary end point is that iron isomaltoside given postoperatively is superior to placebo
      in terms of increase and stability of levels of haemoglobin and other haematological
      parameters.
The Aim: to assess the effect of treatment of preoperative anaemia with intravenous iron on
      haematological parameters for patients after elective colorectal surgery.

      Primary Hypothesis: postoperative treatment with intravenous iron increases the levels of
      haemoglobin, ferritin, red cell count and is superior compared to placebo.

      Secondary effects: treatment with intravenous iron vs placebo provides reduction of blood
      transfusions, postoperative complications and hospital stay.

      The Objectives:

        1. To estimate the rate of preoperative anaemia in patients of elective colorectal surgery.

        2. To assess the dynamic changes of total blood count values in colorectal surgery patients
           treated with postoperative intravenous iron.

        3. To compare the changes in total blood count values over time in colorectal surgery
           patients treated with intravenous iron versus colorectal surgery patients of the control
           group.

      Methods:

      The prospective, double-blinded study includes American Society of Anaesthesiology (ASA)
      I-III patients, aged 18-75 years, admitted for elective colorectal surgery. Preoperatively,
      patients with levels of haemoglobin 90-120 g/l will be identified and their serum ferritin
      will be tested. In cases of ferritin<100 mkg/l, patients will be blindly randomized into one
      of the two groups: treatment group (group T) is given 1000 mg of intravenous iron (iron
      isomaltoside, Orivas, Pharmacosmos) in the postoperative recovery ward and control group
      (group C) which is given the same volume of intravenous saline (placebo).

      Patients in both groups will be provided with general anaesthesia (fentanyl, propofol,
      atracurium, inhaled sevoflurane for maintenance) and after tracheal extubation will be
      transferred to the recovery ward.

      Patient blood tests: total blood count, haemoglobin, haematocrit, mean corpuscular volume
      (MCV), mean corpuscular haemoglobin (MCH), plasma ferritin) will be assessed in both groups 1
      day preoperatively, day 1 and 3 postoperatively, the day of discharge and 4 weeks after
      discharge from the department of surgery. The level of reticulocyte and reticulocyte
      haemoglobin concentration will be determined on the day of discharge and 4 weeks after
      discharge.

      According to the study protocol, groups will also be compared in terms of clinical recovery,
      requirements of intravenous fluids and blood transfusion and duration of hospital stay.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Changes in haemoglobin level
time frame: 4 weeks after surgery
description: Haemoglobin level will be tested in both groups at day 1, 3 postoperatively, day of discharge and 4 weeks after surgery
measure: Changes of plasma ferritin
time frame: 4 weeks after surgery
description: Other haematological variables will be tested in both groups at day 1, 3 postoperatively, day of discharge and 4 weeks after surgery
measure: Changes of red blood cell count
time frame: 4 weeks after surgery
description: Other haematological variables will be tested in both groups at day 1, 3 postoperatively, day of discharge and 4 weeks after surgery
measure: Changes of mean corpuscular volume
time frame: 4 weeks after surgery
description: Other haematological variables will be tested in both groups at day 1, 3 postoperatively, day of discharge and 4 weeks after surgery
measure: Changes of mean corpuscular haemoglobin concentration
time frame: 4 weeks after surgery
description: Other haematological variables will be tested in both groups at day 1, 3 postoperatively, day of discharge and 4 weeks after surgery
measure: Changes of reticulocyte count
time frame: 4 weeks after surgery
description: It will be tested in both groups at the day of discharge and 4 weeks after surgery
measure: Changes of reticulocyte haemoglobin count
time frame: 4 weeks after surgery
description: It will be tested in both groups at the day of discharge and 4 weeks after surgery
measure: Rate of blood transfusion
time frame: From date of randomization until the day of discharge from the hospital, up to 2 weeks after surgery
description: Total amount of blood transfusion units will be counted 2 weeks after surgery in both groups.
measure: Amount of intravenous fluid therapy
time frame: From date of randomization until the day of discharge, up to 2 weeks after surgery
description: Total amount of intravenous fluids will be counted starting from the date of randomization, separately in the operating room, recovery area and each day postoperatively until 2 weeks after surgery in both groups.
measure: Number of participants with perioperative complications
time frame: 4 weeks after surgery
description: Total number of postoperative complications will be counted in both groups.
measure: Duration of hospital stay
time frame: From the date of randomization until the day of discharge, up to 2 weeks after surgery
description: It will be counted in both groups 2 weeks after surgery in both groups.
arm group label: Treatment
arm group type: Active Comparator
description: 1 g of intravenous iron isomaltoside given postoperatively for patients with preoperative anaemia (Hb 90-120 g/l and plasma ferritin<100 mkg/l).
arm group label: Control
arm group type: Placebo Comparator
description: The same amount of intravenous saline for patients with preoperative anaemia (Hb 90-120 g/l and plasma ferritin<100 mkg/l).
intervention type: Drug
intervention name: Iron isomaltoside
description: Intravenous injection 1 g given postoperatively in the recovery ward.
Blood tests including red blood cell count, plasma ferritin, haemoglobin, haematocrit, mean corpuscular volume, mean haemoglobin concentration are made 1 day preoperatively, day 1, day 3 postoperatively, day of discharge and 1 month after discharge.
Reticulocyte count and reticulocyte haemoglobin concentration tests are made on the day of discharge and 1 month after discharge.
Count of total consumption of intravenous blood products. Count of total intravenous fluids. Clinical recovery and complications. Duration of hospital stay.
arm group label: Treatment
other name: Monofer
intervention type: Drug
intervention name: Saline
description: Intravenous injection given postoperatively in the recovery ward.
Blood tests including red blood cell count, plasma ferritin, haemoglobin, haematocrit, mean corpuscular volume, mean haemoglobin concentration are made 1 day preoperatively, day 1, day 3 postoperatively, day of discharge and 1 month after discharge.
Reticulocyte count and reticulocyte haemoglobin concentration tests are made on the day of discharge and 1 month after discharge.
Count of total consumption of intravenous blood products. Count of total intravenous fluids. Clinical recovery and complications. Duration of hospital stay.
arm group label: Control
other name: Sodium chloride
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Andrius Macas, MDPhDProf
role: Study Chair
affiliation: Head of the Department of Anaesthesiology, Medical academy, Lithuanian University of Health Sciences
last name: Jurate Gudaityte, MDPhDAssProf
phone: +37069808531
email: jurate.gudaityte@kaunoklinikos.lt
last name: Andrius Macas, MDPhDProf
phone: +37068639123
email: andrius.macas@kaunoklinikos.lt
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Lithuania
citation: Shander A, Knight K, Thurer R, Adamson J, Spence R. Prevalence and outcomes of anemia in surgery: a systematic review of the literature. Am J Med. 2004 Apr 5;116 Suppl 7A:58S-69S. doi: 10.1016/j.amjmed.2003.12.013.
PMID: 15050887
citation: Edna TH, Karlsen V, Jullumstro E, Lydersen S. Prevalence of anaemia at diagnosis of colorectal cancer: assessment of associated risk factors. Hepatogastroenterology. 2012 May;59(115):713-6. doi: 10.5754/hge11479.
PMID: 22469713
citation: Ward DG, Roberts K, Brookes MJ, Joy H, Martin A, Ismail T, Spychal R, Iqbal T, Tselepis C. Increased hepcidin expression in colorectal carcinogenesis. World J Gastroenterol. 2008 Mar 7;14(9):1339-45. doi: 10.3748/wjg.14.1339.
PMID: 18322945
citation: Ganz T. Hepcidin and iron regulation, 10 years later. Blood. 2011 Apr 28;117(17):4425-33. doi: 10.1182/blood-2011-01-258467. Epub 2011 Feb 23.
PMID: 21346250
citation: Leichtle SW, Mouawad NJ, Lampman R, Singal B, Cleary RK. Does preoperative anemia adversely affect colon and rectal surgery outcomes? J Am Coll Surg. 2011 Feb;212(2):187-94. doi: 10.1016/j.jamcollsurg.2010.09.013.
PMID: 21276532
citation: Cladellas M, Bruguera J, Comin J, Vila J, de Jaime E, Marti J, Gomez M. Is pre-operative anaemia a risk marker for in-hospital mortality and morbidity after valve replacement? Eur Heart J. 2006 May;27(9):1093-9. doi: 10.1093/eurheartj/ehi830. Epub 2006 Mar 14.
PMID: 16537556
citation: Hogan M, Klein AA, Richards T. The impact of anaemia and intravenous iron replacement therapy on outcomes in cardiac surgery. Eur J Cardiothorac Surg. 2015 Feb;47(2):218-26. doi: 10.1093/ejcts/ezu200. Epub 2014 May 13.
PMID: 24824650
citation: Elhenawy AM, Meyer SR, Bagshaw SM, MacArthur RG, Carroll LJ. Role of preoperative intravenous iron therapy to correct anemia before major surgery: study protocol for systematic review and meta-analysis. Syst Rev. 2015 Mar 15;4:29. doi: 10.1186/s13643-015-0016-4.
PMID: 25874460
responsible party type: Sponsor
mesh term: Colorectal Neoplasms
mesh term: Anemia
mesh term: Anemia, Iron-Deficiency
mesh term: Iron Deficiencies
mesh term: Iron isomaltoside 1000
sharing ipd: Yes
ipd description: De-identified individual participant data for all primary and secondary outcome measures will be made available within 6 months of study completion.