The IRONMAN trial: a protocol for a multicentre randomised placebo-controlled trial of intravenous iron in intensive care unit patients with anaemia

Ed Litton, S Baker, Wendy Erber, C French, J Ferrier, D Hawkins, A Higgins, A Hofmann, Bart De Keulenaer, Shannon Farmer, J Mcmorrow, John Olynyk, Toby Richards, S Towler, Steve Webb

    Research output: Contribution to journalArticle

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    Abstract

    BACKGROUND: Allogeneic red blood cell (RBC) transfusion is associated with significant increases in mortality and major morbidity in patients admitted to the intensive care unit, and the blood supplies it requires are an increasingly scarce and costly resource. Despite high levels of compliance with recommended transfusion thresholds in the ICU, RBC transfusion remains common. Novel interventions to reduce the incidence of RBC transfusion are required. OBJECTIVE: To describe the study protocol for a randomised controlled trial, the Intravenous Iron or Placebo for Anaemia in Intensive Care (IRONMAN) trial, comparing intravenous (IV) iron with placebo in patients who are admitted to an ICU and are anaemic. DESIGN, SETTING, PARTICIPANTS AND INTERVENTION: A Phase IIb multicentre, randomised, placebo-controlled trial. Patients admitted to the ICU with a haemoglobin (Hb) level <100 g/L and predicted to require critical care beyond the next calendar day will be randomly assigned in a 1 : 1 ratio to receive IV ferric carboxymaltose (500 mg) or placebo. MAIN OUTCOME MEASURES: The primary end point will be the mean number of RBC units transfused from study enrolment to discharge from hospital. Secondary end points will include change in Hb level and incidence of nosocomial infection. RESULTS AND CONCLUSIONS: The IRONMAN trial is designed to determine whether IV iron administered to patients admitted to an ICU and who are anaemic is associated with a reduction in RBC transfusion, compared with placebo in addition to standard care. The results of this trial may determine whether a Phase III trial of IV iron in ICUs is feasible. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ACTRN12612001249842).
    Original languageEnglish
    Pages (from-to)285-290
    JournalCritical Care and Resuscitation
    Volume16
    Issue number4
    Publication statusPublished - Dec 2014

    Fingerprint

    Clinical Protocols
    Erythrocyte Transfusion
    Intensive Care Units
    Anemia
    Iron
    Randomized Controlled Trials
    Placebos
    Critical Care
    Hemoglobins
    Incidence
    Cross Infection
    New Zealand
    Registries
    Erythrocytes
    Clinical Trials
    Morbidity
    Mortality

    Cite this

    Litton, Ed ; Baker, S ; Erber, Wendy ; French, C ; Ferrier, J ; Hawkins, D ; Higgins, A ; Hofmann, A ; De Keulenaer, Bart ; Farmer, Shannon ; Mcmorrow, J ; Olynyk, John ; Richards, Toby ; Towler, S ; Webb, Steve. / The IRONMAN trial: a protocol for a multicentre randomised placebo-controlled trial of intravenous iron in intensive care unit patients with anaemia. In: Critical Care and Resuscitation. 2014 ; Vol. 16, No. 4. pp. 285-290.
    @article{be27836aa0434e7a98b2910e6577c884,
    title = "The IRONMAN trial: a protocol for a multicentre randomised placebo-controlled trial of intravenous iron in intensive care unit patients with anaemia",
    abstract = "BACKGROUND: Allogeneic red blood cell (RBC) transfusion is associated with significant increases in mortality and major morbidity in patients admitted to the intensive care unit, and the blood supplies it requires are an increasingly scarce and costly resource. Despite high levels of compliance with recommended transfusion thresholds in the ICU, RBC transfusion remains common. Novel interventions to reduce the incidence of RBC transfusion are required. OBJECTIVE: To describe the study protocol for a randomised controlled trial, the Intravenous Iron or Placebo for Anaemia in Intensive Care (IRONMAN) trial, comparing intravenous (IV) iron with placebo in patients who are admitted to an ICU and are anaemic. DESIGN, SETTING, PARTICIPANTS AND INTERVENTION: A Phase IIb multicentre, randomised, placebo-controlled trial. Patients admitted to the ICU with a haemoglobin (Hb) level <100 g/L and predicted to require critical care beyond the next calendar day will be randomly assigned in a 1 : 1 ratio to receive IV ferric carboxymaltose (500 mg) or placebo. MAIN OUTCOME MEASURES: The primary end point will be the mean number of RBC units transfused from study enrolment to discharge from hospital. Secondary end points will include change in Hb level and incidence of nosocomial infection. RESULTS AND CONCLUSIONS: The IRONMAN trial is designed to determine whether IV iron administered to patients admitted to an ICU and who are anaemic is associated with a reduction in RBC transfusion, compared with placebo in addition to standard care. The results of this trial may determine whether a Phase III trial of IV iron in ICUs is feasible. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ACTRN12612001249842).",
    author = "Ed Litton and S Baker and Wendy Erber and C French and J Ferrier and D Hawkins and A Higgins and A Hofmann and {De Keulenaer}, Bart and Shannon Farmer and J Mcmorrow and John Olynyk and Toby Richards and S Towler and Steve Webb",
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    Litton, E, Baker, S, Erber, W, French, C, Ferrier, J, Hawkins, D, Higgins, A, Hofmann, A, De Keulenaer, B, Farmer, S, Mcmorrow, J, Olynyk, J, Richards, T, Towler, S & Webb, S 2014, 'The IRONMAN trial: a protocol for a multicentre randomised placebo-controlled trial of intravenous iron in intensive care unit patients with anaemia' Critical Care and Resuscitation, vol. 16, no. 4, pp. 285-290.

    The IRONMAN trial: a protocol for a multicentre randomised placebo-controlled trial of intravenous iron in intensive care unit patients with anaemia. / Litton, Ed; Baker, S; Erber, Wendy; French, C; Ferrier, J; Hawkins, D; Higgins, A; Hofmann, A; De Keulenaer, Bart; Farmer, Shannon; Mcmorrow, J; Olynyk, John; Richards, Toby; Towler, S; Webb, Steve.

    In: Critical Care and Resuscitation, Vol. 16, No. 4, 12.2014, p. 285-290.

    Research output: Contribution to journalArticle

    TY - JOUR

    T1 - The IRONMAN trial: a protocol for a multicentre randomised placebo-controlled trial of intravenous iron in intensive care unit patients with anaemia

    AU - Litton, Ed

    AU - Baker, S

    AU - Erber, Wendy

    AU - French, C

    AU - Ferrier, J

    AU - Hawkins, D

    AU - Higgins, A

    AU - Hofmann, A

    AU - De Keulenaer, Bart

    AU - Farmer, Shannon

    AU - Mcmorrow, J

    AU - Olynyk, John

    AU - Richards, Toby

    AU - Towler, S

    AU - Webb, Steve

    PY - 2014/12

    Y1 - 2014/12

    N2 - BACKGROUND: Allogeneic red blood cell (RBC) transfusion is associated with significant increases in mortality and major morbidity in patients admitted to the intensive care unit, and the blood supplies it requires are an increasingly scarce and costly resource. Despite high levels of compliance with recommended transfusion thresholds in the ICU, RBC transfusion remains common. Novel interventions to reduce the incidence of RBC transfusion are required. OBJECTIVE: To describe the study protocol for a randomised controlled trial, the Intravenous Iron or Placebo for Anaemia in Intensive Care (IRONMAN) trial, comparing intravenous (IV) iron with placebo in patients who are admitted to an ICU and are anaemic. DESIGN, SETTING, PARTICIPANTS AND INTERVENTION: A Phase IIb multicentre, randomised, placebo-controlled trial. Patients admitted to the ICU with a haemoglobin (Hb) level <100 g/L and predicted to require critical care beyond the next calendar day will be randomly assigned in a 1 : 1 ratio to receive IV ferric carboxymaltose (500 mg) or placebo. MAIN OUTCOME MEASURES: The primary end point will be the mean number of RBC units transfused from study enrolment to discharge from hospital. Secondary end points will include change in Hb level and incidence of nosocomial infection. RESULTS AND CONCLUSIONS: The IRONMAN trial is designed to determine whether IV iron administered to patients admitted to an ICU and who are anaemic is associated with a reduction in RBC transfusion, compared with placebo in addition to standard care. The results of this trial may determine whether a Phase III trial of IV iron in ICUs is feasible. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ACTRN12612001249842).

    AB - BACKGROUND: Allogeneic red blood cell (RBC) transfusion is associated with significant increases in mortality and major morbidity in patients admitted to the intensive care unit, and the blood supplies it requires are an increasingly scarce and costly resource. Despite high levels of compliance with recommended transfusion thresholds in the ICU, RBC transfusion remains common. Novel interventions to reduce the incidence of RBC transfusion are required. OBJECTIVE: To describe the study protocol for a randomised controlled trial, the Intravenous Iron or Placebo for Anaemia in Intensive Care (IRONMAN) trial, comparing intravenous (IV) iron with placebo in patients who are admitted to an ICU and are anaemic. DESIGN, SETTING, PARTICIPANTS AND INTERVENTION: A Phase IIb multicentre, randomised, placebo-controlled trial. Patients admitted to the ICU with a haemoglobin (Hb) level <100 g/L and predicted to require critical care beyond the next calendar day will be randomly assigned in a 1 : 1 ratio to receive IV ferric carboxymaltose (500 mg) or placebo. MAIN OUTCOME MEASURES: The primary end point will be the mean number of RBC units transfused from study enrolment to discharge from hospital. Secondary end points will include change in Hb level and incidence of nosocomial infection. RESULTS AND CONCLUSIONS: The IRONMAN trial is designed to determine whether IV iron administered to patients admitted to an ICU and who are anaemic is associated with a reduction in RBC transfusion, compared with placebo in addition to standard care. The results of this trial may determine whether a Phase III trial of IV iron in ICUs is feasible. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ACTRN12612001249842).

    M3 - Article

    VL - 16

    SP - 285

    EP - 290

    JO - Critical Care and Resuscitation

    JF - Critical Care and Resuscitation

    SN - 1441-2772

    IS - 4

    ER -