<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/NCT01692418</url>
  </required_header>
  <id_info>
    <org_study_id>12/0246</org_study_id>
    <secondary_id>2012-002786-35</secondary_id>
    <secondary_id>10/104/06</secondary_id>
    <secondary_id>12/EE/0445</secondary_id>
    <secondary_id>ISRCTN67322816</secondary_id>
    <nct_id>NCT01692418</nct_id>
  </id_info>
  <brief_title>Preoperative Intravenous Iron to Treat Anaemia in Major Surgery</brief_title>
  <acronym>PREVENTT</acronym>
  <official_title>A Randomised Double-blind Controlled Phase III Study to Compare the Efficacy and Safety of Intravenous Ferric Carboxymaltose With Placebo in Patients With Anaemia Undergoing Major Open Abdominal Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University College, London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University College, London</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Anaemia is a common problem in patients undergoing surgery. About half of patients undergoing&#xD;
      a major operation have anaemia, often a consequence of the disease requiring surgery. Anaemia&#xD;
      causes patients to feel tired and unwell. Anaemia at the time of surgery increases the&#xD;
      requirement for blood transfusion (50% if anaemic compared to only 15% without anaemia). Both&#xD;
      anaemia and blood transfusions are associated with increased complications from surgery,&#xD;
      delayed recovery and prolonged hospital stay. The investigators propose that giving&#xD;
      intravenous iron before operation can be used to correct anaemia in these patients.&#xD;
      Consequently if patients are not anaemic they are less likely to need blood transfusion. Also&#xD;
      patients feel better and their health is improved before their operation they are more likely&#xD;
      to tolerate the surgery, recover faster, be less likely to have complications from surgery&#xD;
      and return home sooner. This will have benefits to the individual patient and also to the NHS&#xD;
      by reducing costs.&#xD;
&#xD;
      Oral Iron tablets are not effective as they take 3-6 months to increase blood levels, the&#xD;
      tablets are often not tolerated as cause constipation or stomach pain, overall only 30-50% of&#xD;
      people continue taking oral iron. A full treatment dose of intravenous iron can be given in&#xD;
      15 minutes with minimal side effects. The effect is to rapidly increase blood counts in 2-4&#xD;
      weeks. The investigators propose that this treatment can be incorporated to patient&#xD;
      preparation pathways for surgery as an outpatient without the need for additional visits to&#xD;
      hospital.&#xD;
&#xD;
      Small studies have suggested a benefit of iron therapy in orthopaedic and gynaecological&#xD;
      surgery. This study will look at 500 patients undergoing major surgery at 20 hospitals in the&#xD;
      UK. The investigators anticipate half of patients treated will have their anaemia corrected&#xD;
      before operation. Patients with anaemia will be identified as part of the routine blood tests&#xD;
      taken preoperatively and invited to take part in the study. Following informed consent, they&#xD;
      will be randomly allocated to receive either intravenous iron or a placebo infusion of&#xD;
      saline. Intravenous iron is a dark liquid given continuously into a vein over 15 minutes. To&#xD;
      ensure neither doctor nor patient knows which treatment is being given both infusions will be&#xD;
      prepared and administered by an unblinded authorised person via a black bag through black&#xD;
      tubing. There will be no other changes to the patient's normal treatment.&#xD;
&#xD;
      The main aim of this study is to assess if intravenous iron will reduce the need for blood&#xD;
      transfusion in the time period around the operation. Further outcome measures will include;&#xD;
      patient-reported quality of life, complications, length of hospital stay, and cost. Outcomes&#xD;
      will be assessed both during hospital stay and after the patient has been discharged. The&#xD;
      trial will be run through a Clinical Trials Unit with considerable experience in conducting&#xD;
      large trials. The team has a large range of experience in anaemia management and assessment&#xD;
      of complications, quality of life and the cost of health care.&#xD;
&#xD;
      The main aim of this study is to assess if intravenous iron will reduce the need for blood&#xD;
      transfusion in the time period around the operation. Further outcome measures will include;&#xD;
      patient-reported quality of life, complications, length of hospital stay, and cost. Outcomes&#xD;
      will be assessed both during hospital stay and after the patient has been discharged. The&#xD;
      trial will be run through a Clinical Trials Unit with considerable experience in conducting&#xD;
      large trials. The team has a large range of experience in anaemia management and assessment&#xD;
      of complications, quality of life and the cost of health care.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2014</start_date>
  <completion_date type="Actual">May 2019</completion_date>
  <primary_completion_date type="Actual">May 2019</primary_completion_date>
  <phase>Phase 3</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Risk of blood transfusion or death</measure>
    <time_frame>From randomisation until 30-days following the index operation</time_frame>
    <description>Co-primary outcome</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Blood transfusion rate (including repeat transfusions)</measure>
    <time_frame>From randomisation until 30-days following the index operation</time_frame>
    <description>Co-primary outcome</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in haemoglobin levels</measure>
    <time_frame>From randomisation to (i) day of index operation, (ii) 8-weeks post index operation and (iii) 6 months post index operation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total number of units of blood or blood products cross matched, total number of packed red cells and any blood products transfused</measure>
    <time_frame>From randomisation to 30 days post index operation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post operative morbidity survey (POMS) outcomes (outcomes will be presence of morbidity defined by the domains of the POMS e.g. gastrointestinal, cardiovascular)</measure>
    <time_frame>At days 3, 5, 7 and 14 following the index operation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health-related quality of life: Change in The Multidimensional Fatigue Inventory (MFI) questionnaire total score</measure>
    <time_frame>From baseline to the 10 day assessment and at 8 weeks and 6 months post operatively</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health-related quality of life: Change in European Quality of Life: 5 Dimensions-5 Levels (EQ-5D-5L) questionnaire total score</measure>
    <time_frame>From baseline to the 10 day assessment and at 8 weeks and six months post operatively</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health-related quality of life: Change in Single Question Outcome Measure (SQOM)</measure>
    <time_frame>From baseline to the 10 day assessment and at 8 weeks and six months post operatively</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health resource utilisation</measure>
    <time_frame>Pre-admission, during admission for index operation, 8 weeks post index operation, and 6 months post index operation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Calculated direct, indirect and total costs for the NHS from two perspectives (payer's and societal perspective)</measure>
    <time_frame>From baseline to 6 months post-surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost effectiveness of treatment options using relevant effectiveness parameters</measure>
    <time_frame>From baseline to 6 months post-surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Any reaction or side effect from trial therapy</measure>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Any reaction or side effect from whole blood or blood product, transfusion reaction</measure>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serious Adverse Events (SAEs) and Suspected Unexpected Serious Adverse Reactions (SUSARs)</measure>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of hospital stay</measure>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>8 weeks and 6 months post-operatively</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Readmission</measure>
    <time_frame>Within 8 weeks and within 6 months of the index operation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood transfusion</measure>
    <time_frame>From randomisation to 8 weeks and 6 months post-operatively</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in e-GFR</measure>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">487</enrollment>
  <condition>Anaemia</condition>
  <arm_group>
    <arm_group_label>Ferric carboxymaltose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1000mg of ferric carboxymaltose will be administered as an i.v. infusion (100ml normal saline) over a minimum of 15 minutes</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Normal saline will be administered as an i.v. infusion (100ml normal saline) over a minimum of 15 minutes</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ferric carboxymaltose</intervention_name>
    <description>1000mg of ferric carboxymaltose will be administered as an i.v. infusion (100ml normal saline)</description>
    <arm_group_label>Ferric carboxymaltose</arm_group_label>
    <other_name>Ferinject</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Normal saline</intervention_name>
    <description>Normal saline will be administered as an i.v. infusion (100ml normal saline)</description>
    <arm_group_label>Ferric carboxymaltose</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. At least 18 years of age and signed written informed consent.&#xD;
&#xD;
          2. Patients undergoing elective major open abdominal surgery.&#xD;
&#xD;
               -  The Indication for operation may be for benign or malignant disease.&#xD;
&#xD;
               -  Major Surgery is defined as an operation of anticipated duration more than one&#xD;
                  hour.&#xD;
&#xD;
          3. Screening haemoglobin (Hb) greater than or equal to 90 g/L (9.0 g/dL) but below or&#xD;
             equal to 120 g/L (12.0 g/dL) in women or 130 g/L (13.0 g/dL) in men within four weeks&#xD;
             of randomisation.&#xD;
&#xD;
          4. Randomisation and administration of study infusion a minimum of 10 days and maximum 42&#xD;
             days before planned operation.&#xD;
&#xD;
          5. Negative pregnancy test for women of childbearing potential (within last 7 days), and&#xD;
             agree to use effective form of contraception until 6 weeks post treatment.&#xD;
&#xD;
          6. Laboratory data used for determination of eligibility at the baseline visit must not&#xD;
             be older than four weeks.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients undergoing laparoscopic surgery.&#xD;
&#xD;
          2. Body weight under 50kg.&#xD;
&#xD;
          3. Known history of acquired iron overload, or family history of haemochromatosis or&#xD;
             thalassemia or TSAT &gt; 50%.&#xD;
&#xD;
          4. Known reason for anaemia (e.g. untreated B12 or folate deficiency or&#xD;
             haemoglobinopathy).&#xD;
&#xD;
          5. Known hypersensitivity to ferric carboxymaltose (Ferinject®) or its excipients.&#xD;
&#xD;
          6. Temperature &gt; 37.5 degrees celsius or patient on non-prophylactic antibiotics&#xD;
&#xD;
          7. Known chronic liver disease&#xD;
&#xD;
          8. If clinically indicated for the patient to have LFT's as part of pre-assessment for&#xD;
             surgery and this screening alanine transaminase (ALT) or aspartate transaminase (AST)&#xD;
             is above three times the upper limit of the normal range.&#xD;
&#xD;
          9. Received erythropoietin or i.v. iron therapy in the previous 12 weeks.&#xD;
&#xD;
         10. Immunosuppressive therapy (for organ transplantation) or renal dialysis (current or&#xD;
             planned within the next 12 months).&#xD;
&#xD;
         11. Patients with severe asthma or severe allergy (requiring hospitalisation within the&#xD;
             last 12 months).&#xD;
&#xD;
         12. Unfit for elective surgery.&#xD;
&#xD;
         13. Pregnancy or lactation.&#xD;
&#xD;
         14. Inability to fully comprehend and/or perform study procedures in the investigator's&#xD;
             opinion.&#xD;
&#xD;
         15. Patient involvement in another IMP trial within the previous 4 weeks, prior to&#xD;
             randomisation. Involvement in another IMP trial, following randomisation, that may&#xD;
             impact on the results of the PREVENTT trial.&#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>Toby Richards, MD FRCS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University College, London</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Basildon University Hospital</name>
      <address>
        <city>Basildon</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Blackpool Teaching Hospitals</name>
      <address>
        <city>Blackpool</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southmead Hospital</name>
      <address>
        <city>Bristol</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Broomfield Hospital</name>
      <address>
        <city>Broomfield</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Countess of Chester Hospital</name>
      <address>
        <city>Chester</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Russells Hall Hospital</name>
      <address>
        <city>Dudley</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Infirmary of Edinburgh</name>
      <address>
        <city>Edinburgh</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Queen Elizabeth Hospital</name>
      <address>
        <city>Gateshead</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hereford County Hospital</name>
      <address>
        <city>Hereford</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hillingdon Hospital</name>
      <address>
        <city>Hillingdon</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St James's Hospital</name>
      <address>
        <city>Leeds</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aintree University Hospital</name>
      <address>
        <city>Liverpool</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Liverpool Women's Hospital</name>
      <address>
        <city>Liverpool</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University College London</name>
      <address>
        <city>London</city>
        <zip>WC1E 6AU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guy's and St Thomas' Hospital</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Imperial College Hospital</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>King's College Hospital</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Marsden</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>James Cook University Hospital</name>
      <address>
        <city>Middlesbrough</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Queen's Medical Centre</name>
      <address>
        <city>Nottingham</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pennine Acute Hospitals</name>
      <address>
        <city>Oldham</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>John Radcliffe Hospital</name>
      <address>
        <city>Oxford</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peterborough and Stamford Hospitals</name>
      <address>
        <city>Peterborough</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Salford Royal</name>
      <address>
        <city>Salford</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northern General Hospital</name>
      <address>
        <city>Sheffield</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southampton General Hospital</name>
      <address>
        <city>Southampton</city>
        <zip>SO16 6YD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Morriston Hospital</name>
      <address>
        <city>Swansea</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Cornwall Hospital</name>
      <address>
        <city>Truro</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <link>
    <url>http://preventt.lshtm.ac.uk/</url>
    <description>Study website</description>
  </link>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>September 14, 2012</study_first_submitted>
  <study_first_submitted_qc>September 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2012</study_first_posted>
  <last_update_submitted>May 30, 2019</last_update_submitted>
  <last_update_submitted_qc>May 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 3, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Anaemia</keyword>
  <keyword>Blood transfusion</keyword>
  <keyword>Surgery</keyword>
  <keyword>Iron</keyword>
  <keyword>Ferric carboxymaltose</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anemia</mesh_term>
  </condition_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/NCT01692418
org study id: 12/0246
secondary id: 2012-002786-35
secondary id: 10/104/06
secondary id: 12/EE/0445
secondary id: ISRCTN67322816
nct id: NCT01692418
lead sponsor: 
has dmc: Yes
Anaemia is a common problem in patients undergoing surgery. About half of patients undergoing
      a major operation have anaemia, often a consequence of the disease requiring surgery. Anaemia
      causes patients to feel tired and unwell. Anaemia at the time of surgery increases the
      requirement for blood transfusion (50% if anaemic compared to only 15% without anaemia). Both
      anaemia and blood transfusions are associated with increased complications from surgery,
      delayed recovery and prolonged hospital stay. The investigators propose that giving
      intravenous iron before operation can be used to correct anaemia in these patients.
      Consequently if patients are not anaemic they are less likely to need blood transfusion. Also
      patients feel better and their health is improved before their operation they are more likely
      to tolerate the surgery, recover faster, be less likely to have complications from surgery
      and return home sooner. This will have benefits to the individual patient and also to the NHS
      by reducing costs.

      Oral Iron tablets are not effective as they take 3-6 months to increase blood levels, the
      tablets are often not tolerated as cause constipation or stomach pain, overall only 30-50% of
      people continue taking oral iron. A full treatment dose of intravenous iron can be given in
      15 minutes with minimal side effects. The effect is to rapidly increase blood counts in 2-4
      weeks. The investigators propose that this treatment can be incorporated to patient
      preparation pathways for surgery as an outpatient without the need for additional visits to
      hospital.

      Small studies have suggested a benefit of iron therapy in orthopaedic and gynaecological
      surgery. This study will look at 500 patients undergoing major surgery at 20 hospitals in the
      UK. The investigators anticipate half of patients treated will have their anaemia corrected
      before operation. Patients with anaemia will be identified as part of the routine blood tests
      taken preoperatively and invited to take part in the study. Following informed consent, they
      will be randomly allocated to receive either intravenous iron or a placebo infusion of
      saline. Intravenous iron is a dark liquid given continuously into a vein over 15 minutes. To
      ensure neither doctor nor patient knows which treatment is being given both infusions will be
      prepared and administered by an unblinded authorised person via a black bag through black
      tubing. There will be no other changes to the patient's normal treatment.

      The main aim of this study is to assess if intravenous iron will reduce the need for blood
      transfusion in the time period around the operation. Further outcome measures will include;
      patient-reported quality of life, complications, length of hospital stay, and cost. Outcomes
      will be assessed both during hospital stay and after the patient has been discharged. The
      trial will be run through a Clinical Trials Unit with considerable experience in conducting
      large trials. The team has a large range of experience in anaemia management and assessment
      of complications, quality of life and the cost of health care.

      The main aim of this study is to assess if intravenous iron will reduce the need for blood
      transfusion in the time period around the operation. Further outcome measures will include;
      patient-reported quality of life, complications, length of hospital stay, and cost. Outcomes
      will be assessed both during hospital stay and after the patient has been discharged. The
      trial will be run through a Clinical Trials Unit with considerable experience in conducting
      large trials. The team has a large range of experience in anaemia management and assessment
      of complications, quality of life and the cost of health care.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Risk of blood transfusion or death
time frame: From randomisation until 30-days following the index operation
description: Co-primary outcome
measure: Blood transfusion rate (including repeat transfusions)
time frame: From randomisation until 30-days following the index operation
description: Co-primary outcome
measure: Change in haemoglobin levels
time frame: From randomisation to (i) day of index operation, (ii) 8-weeks post index operation and (iii) 6 months post index operation
measure: Total number of units of blood or blood products cross matched, total number of packed red cells and any blood products transfused
time frame: From randomisation to 30 days post index operation
measure: Post operative morbidity survey (POMS) outcomes (outcomes will be presence of morbidity defined by the domains of the POMS e.g. gastrointestinal, cardiovascular)
time frame: At days 3, 5, 7 and 14 following the index operation
measure: Health-related quality of life: Change in The Multidimensional Fatigue Inventory (MFI) questionnaire total score
time frame: From baseline to the 10 day assessment and at 8 weeks and 6 months post operatively
measure: Health-related quality of life: Change in European Quality of Life: 5 Dimensions-5 Levels (EQ-5D-5L) questionnaire total score
time frame: From baseline to the 10 day assessment and at 8 weeks and six months post operatively
measure: Health-related quality of life: Change in Single Question Outcome Measure (SQOM)
time frame: From baseline to the 10 day assessment and at 8 weeks and six months post operatively
measure: Health resource utilisation
time frame: Pre-admission, during admission for index operation, 8 weeks post index operation, and 6 months post index operation
measure: Calculated direct, indirect and total costs for the NHS from two perspectives (payer's and societal perspective)
time frame: From baseline to 6 months post-surgery
measure: Cost effectiveness of treatment options using relevant effectiveness parameters
time frame: From baseline to 6 months post-surgery
measure: Any reaction or side effect from trial therapy
measure: Any reaction or side effect from whole blood or blood product, transfusion reaction
measure: Serious Adverse Events (SAEs) and Suspected Unexpected Serious Adverse Reactions (SUSARs)
measure: Length of hospital stay
measure: Mortality
time frame: 8 weeks and 6 months post-operatively
measure: Readmission
time frame: Within 8 weeks and within 6 months of the index operation
measure: Blood transfusion
time frame: From randomisation to 8 weeks and 6 months post-operatively
measure: Change in e-GFR
arm group label: Ferric carboxymaltose
arm group type: Experimental
description: 1000mg of ferric carboxymaltose will be administered as an i.v. infusion (100ml normal saline) over a minimum of 15 minutes
arm group label: Placebo
arm group type: Placebo Comparator
description: Normal saline will be administered as an i.v. infusion (100ml normal saline) over a minimum of 15 minutes
intervention type: Drug
intervention name: Ferric carboxymaltose
description: 1000mg of ferric carboxymaltose will be administered as an i.v. infusion (100ml normal saline)
arm group label: Ferric carboxymaltose
other name: Ferinject
intervention type: Drug
intervention name: Normal saline
description: Normal saline will be administered as an i.v. infusion (100ml normal saline)
arm group label: Ferric carboxymaltose
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Toby Richards, MD FRCS
role: Principal Investigator
affiliation: University College, London
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country: United Kingdom
url: http://preventt.lshtm.ac.uk/
description: Study website
responsible party type: Sponsor
mesh term: Anemia