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

Edward Litton, Stuart Baker, Wendy Erber, Craig French, Janet Ferrier, David Hawkins, Alisa Higgins, Axel Hofmann, Bart L De Keulenaer, Shannon Farmer, Julie McMorrow, John K Olynyk, Toby Richards, Simon C B Towler, Steven Charles Webb

Research output: Contribution to journalArticleOther

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
Number of pages6
JournalCritical Care and Resuscitation
Volume16
Issue number4
Publication statusPublished - 1 Dec 2014

Cite this

Litton, Edward ; Baker, Stuart ; Erber, Wendy ; French, Craig ; Ferrier, Janet ; Hawkins, David ; Higgins, Alisa ; Hofmann, Axel ; De Keulenaer, Bart L ; Farmer, Shannon ; McMorrow, Julie ; Olynyk, John K ; Richards, Toby ; Towler, Simon C B ; Webb, Steven Charles. / 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.
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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).",
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Litton, E, Baker, S, Erber, W, French, C, Ferrier, J, Hawkins, D, Higgins, A, Hofmann, A, De Keulenaer, BL, Farmer, S, McMorrow, J, Olynyk, JK, Richards, T, Towler, SCB & Webb, SC 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, Edward; Baker, Stuart; Erber, Wendy; French, Craig; Ferrier, Janet; Hawkins, David; Higgins, Alisa; Hofmann, Axel; De Keulenaer, Bart L; Farmer, Shannon; McMorrow, Julie; Olynyk, John K; Richards, Toby; Towler, Simon C B; Webb, Steven Charles.

In: Critical Care and Resuscitation, Vol. 16, No. 4, 01.12.2014, p. 285-290.

Research output: Contribution to journalArticleOther

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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, Edward

AU - Baker, Stuart

AU - Erber, Wendy

AU - French, Craig

AU - Ferrier, Janet

AU - Hawkins, David

AU - Higgins, Alisa

AU - Hofmann, Axel

AU - De Keulenaer, Bart L

AU - Farmer, Shannon

AU - McMorrow, Julie

AU - Olynyk, John K

AU - Richards, Toby

AU - Towler, Simon C B

AU - Webb, Steven Charles

PY - 2014/12/1

Y1 - 2014/12/1

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).

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