ITHRIVE: Iron and erythropoietin use in anaemic patients in the intensive care

The primary objective of this trial is to determine the feasibility of a pivotal clinical trial of intravenous iron and erythropoietin in adult survivors of critical illness requiring treatment in the intensive care unit. The hypothesis of the pilot phase of the trial is that a clinical trial of intravenous iron and erythropoietin is feasible based on the capacity of the study investigators to enrol sufficient eligible participants and deliver the study medications and follow up the patients appropriately. Demonstrating this would provide evidence that a trial with a much larger number of patients should be undertaken to assess safety and efficacy. The primary objective of the clinical phase of this trial is to determine the safety and efficacy of intravenous iron and erythropoietin in adult survivors of critical illness requiring treatment in the intensive care unit. In both phases the trial is parallel group, placebo-controlled, blinded, randomised trial that will allocate patients who are recovering in an ICU after an episode of critical illness and who are anaemic, in a 1:1 ratio, to intravenous iron and intravenous erythropoietin alfa in addition to standard care, or placebo in addition to standard care. The pilot phase was conducted at a single centre, the larger clinical trial is planned to be multicentre.