• Edward Litton, Stuart Baker, Wendy Erber, Craig French, Janet Ferrier, David Hawkins, Alisa M Higgins, Axel Hofmann, Bart L De Keulenaer, Shannon Farmer, Julie McMorrow, John Olynyk, Toby Richards, Simon Towler, Steve Webb, and Australian and New Zealand Intensive Care Society Clinical Trials Group.
• Royal Perth Hospital, Perth, WA, Australia. ed.litton@health.wa.gov.au.
• Crit Care Resusc. 2014 Dec 1;16(4):285-90.

BackgroundAllogeneic 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.ObjectiveTo 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 InterventionA 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 MeasuresThe 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 ConclusionsThe 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 RegistrationAustralian New Zealand Clinical Trials Registry (ACTRN12612001249842).

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