Edward Litton1, Stuart Baker2, Wendy Erber3, Craig French4, Janet Ferrier5, David Hawkins6, Alisa M Higgins7, Axel Hofmann8, Bart L De Keulenaer9, Shannon Farmer10, Julie McMorrow5, John Olynyk11, Toby Richards12, Simon Towler5, Steve Webb5. 1. Royal Perth Hospital, Perth, WA, Australia. ed.litton@health.wa.gov.au. 2. Sir Charles Gairdner Hospital, Perth, WA, Australia. 3. School of Pathology and Laboratory Medicine, University of Western Australia, Perth, WA, Australia. 4. Western Health, Melbourne, VIC, Australia. 5. Royal Perth Hospital, Perth, WA, Australia. 6. Joondalup Health Campus, Perth, WA, Australia. 7. Centre of Research Excellence for Patient Blood Management in Critical Illness and Trauma, Monash University, Melbourne, VIC, Australia. 8. Medical Society for Blood Management, Laxenburg, Austria. 9. Fremantle Hospital, Perth, WA, Australia. 10. Centre for Population Health Research, Curtin University, Perth, WA, Australia. 11. School of Medicine and Pharmacology, University of Western Australia, Perth, WA, Australia. 12. School of Surgery, University of Western Australia, Perth, WA, Australia.
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 receiveIV 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).
RCT Entities:
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).
Authors: Edward Litton; Stuart Baker; Wendy N Erber; Shannon Farmer; Janet Ferrier; Craig French; Joel Gummer; David Hawkins; Alisa Higgins; Axel Hofmann; Bart De Keulenaer; Julie McMorrow; John K Olynyk; Toby Richards; Simon Towler; Robert Trengove; Steve Webb Journal: Intensive Care Med Date: 2016-09-30 Impact factor: 17.440
Authors: Edward Litton; Stuart Baker; Wendy Erber; Shannon Farmer; Janet Ferrier; Craig French; Joel Gummer; David Hawkins; Alisa Higgins; Axel Hofmann; Bart De Keulenaer; Julie McMorrow; John K Olynyk; Toby Richards; Simon Towler; Robert Trengove; Steve Webb Journal: J Intensive Care Date: 2018-09-10
Authors: Akshay Shah; Noémi B Roy; Stuart McKechnie; Carolyn Doree; Sheila A Fisher; Simon J Stanworth Journal: Crit Care Date: 2016-09-29 Impact factor: 9.097