The IRONMAN trial: a protocol for a multicentre randomised placebo-controlled trial of intravenous iron in intensive care unit patients with anaemia
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...
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| Format: | Journal Article |
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Australasian Academy of Critical Care Medicine
2014
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| Online Access: | http://hdl.handle.net/20.500.11937/34588 |
| _version_ | 1848754263530930176 |
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| author | Litton, E. Baker, S. Erber, W. French, C. Ferrier, J. Hawkins, D. Higgins, A. Hofmann, Axel De Keulenaer, B. Farmer, Shannon McMorrow, J. Olynyk, John Richards, T. Towler, Simon Webb, S. |
| author_facet | Litton, E. Baker, S. Erber, W. French, C. Ferrier, J. Hawkins, D. Higgins, A. Hofmann, Axel De Keulenaer, B. Farmer, Shannon McMorrow, J. Olynyk, John Richards, T. Towler, Simon Webb, S. |
| author_sort | Litton, E. |
| building | Curtin Institutional Repository |
| collection | Online Access |
| description | 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). |
| first_indexed | 2025-11-14T08:37:38Z |
| format | Journal Article |
| id | curtin-20.500.11937-34588 |
| institution | Curtin University Malaysia |
| institution_category | Local University |
| last_indexed | 2025-11-14T08:37:38Z |
| publishDate | 2014 |
| publisher | Australasian Academy of Critical Care Medicine |
| recordtype | eprints |
| repository_type | Digital Repository |
| spelling | curtin-20.500.11937-345882017-01-30T13:44:26Z The IRONMAN trial: a protocol for a multicentre randomised placebo-controlled trial of intravenous iron in intensive care unit patients with anaemia Litton, E. Baker, S. Erber, W. French, C. Ferrier, J. Hawkins, D. Higgins, A. Hofmann, Axel De Keulenaer, B. Farmer, Shannon McMorrow, J. Olynyk, John Richards, T. Towler, Simon Webb, S. intensive care unit IV iron anaemic placebo-controlled trial transfusion 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). 2014 Journal Article http://hdl.handle.net/20.500.11937/34588 Australasian Academy of Critical Care Medicine fulltext |
| spellingShingle | intensive care unit IV iron anaemic placebo-controlled trial transfusion Litton, E. Baker, S. Erber, W. French, C. Ferrier, J. Hawkins, D. Higgins, A. Hofmann, Axel De Keulenaer, B. Farmer, Shannon McMorrow, J. Olynyk, John Richards, T. Towler, Simon Webb, S. The IRONMAN trial: a protocol for a multicentre randomised placebo-controlled trial of intravenous iron in intensive care unit patients with anaemia |
| title | The IRONMAN trial: a protocol for a multicentre randomised placebo-controlled trial of intravenous iron in intensive care unit patients with anaemia |
| title_full | The IRONMAN trial: a protocol for a multicentre randomised placebo-controlled trial of intravenous iron in intensive care unit patients with anaemia |
| title_fullStr | The IRONMAN trial: a protocol for a multicentre randomised placebo-controlled trial of intravenous iron in intensive care unit patients with anaemia |
| title_full_unstemmed | The IRONMAN trial: a protocol for a multicentre randomised placebo-controlled trial of intravenous iron in intensive care unit patients with anaemia |
| title_short | The IRONMAN trial: a protocol for a multicentre randomised placebo-controlled trial of intravenous iron in intensive care unit patients with anaemia |
| title_sort | ironman trial: a protocol for a multicentre randomised placebo-controlled trial of intravenous iron in intensive care unit patients with anaemia |
| topic | intensive care unit IV iron anaemic placebo-controlled trial transfusion |
| url | http://hdl.handle.net/20.500.11937/34588 |