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.
  
  
  METHODS
  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.
  
  
  METHODS
  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.
  
  
  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.
  
  
  BACKGROUND
  Australian New Zealand Clinical Trials Registry (ACTRN12612001249842).
authors.affiliation: Royal Perth Hospital, Perth, WA, Australia. ed.litton@health.wa.gov.au.
authors.forename: Edward
authors.initials: E
authors.lastname: Litton
authors.affiliation: Sir Charles Gairdner Hospital, Perth, WA, Australia.
authors.forename: Stuart
authors.initials: S
authors.lastname: Baker
authors.affiliation: School of Pathology and Laboratory Medicine, University of Western Australia, Perth, WA, Australia.
authors.forename: Wendy
authors.initials: W
authors.lastname: Erber
authors.affiliation: Western Health, Melbourne, VIC, Australia.
authors.forename: Craig
authors.initials: C
authors.lastname: French
authors.affiliation: Royal Perth Hospital, Perth, WA, Australia.
authors.forename: Janet
authors.initials: J
authors.lastname: Ferrier
authors.affiliation: Joondalup Health Campus, Perth, WA, Australia.
authors.forename: David
authors.initials: D
authors.lastname: Hawkins
authors.affiliation: Centre of Research Excellence for Patient Blood Management in Critical Illness and Trauma, Monash University, Melbourne, VIC, Australia.
authors.forename: Alisa M
authors.initials: AM
authors.lastname: Higgins
authors.affiliation: Medical Society for Blood Management, Laxenburg, Austria.
authors.forename: Axel
authors.initials: A
authors.lastname: Hofmann
authors.affiliation: Fremantle Hospital, Perth, WA, Australia.
authors.forename: Bart L De
authors.initials: BL
authors.lastname: Keulenaer
authors.affiliation: Centre for Population Health Research, Curtin University, Perth, WA, Australia.
authors.forename: Shannon
authors.initials: S
authors.lastname: Farmer
authors.affiliation: Royal Perth Hospital, Perth, WA, Australia.
authors.forename: Julie
authors.initials: J
authors.lastname: McMorrow
authors.affiliation: School of Medicine and Pharmacology, University of Western Australia, Perth, WA, Australia.
authors.forename: John
authors.initials: J
authors.lastname: Olynyk
authors.affiliation: School of Surgery, University of Western Australia, Perth, WA, Australia.
authors.forename: Toby
authors.initials: T
authors.lastname: Richards
authors.affiliation: Royal Perth Hospital, Perth, WA, Australia.
authors.forename: Simon
authors.initials: S
authors.lastname: Towler
authors.affiliation: Royal Perth Hospital, Perth, WA, Australia.
authors.forename: Steve
authors.initials: S
authors.lastname: Webb
mesh_terms: D000740:Anemia / Q000188:drug therapy*; D002985:Clinical Protocols; D003422:Critical Care; D005290:Ferric Compounds / Q000008:administration & dosage*; D007262:Infusions, Intravenous; D008320:Maltose / Q000008:administration & dosage / Q000031:analogs & derivatives*; D012107:Research Design
chemical_list: D005290:Ferric Compounds; C522335:ferric carboxymaltose; D008320:Maltose