AMBLE Trial: Iron Deficiency Anaemia in Major Cardiac, Abdominal and VascuLar surgery patients and Effect on functional outcomes

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Iron deficiency is the commonest nutritional deficiency globally, affecting 2 billion people and is the leading cause of anaemia. Iron deficiency anaemia makes people tired and unwell as well as impacting physical function, it is a WHO top 10 leading cause for disability. Anaemia is common in patients undergoing major surgery and associated with worse patient outcomes and increased post operative mortality. The aim of this trial is to explore the mechanisms of iron deficiency over the perioperative time period in patients undergoing cardiac, abdominal and vascular surgery and the response to intravenous iron therapy that bypasses the normal Hepcidin mediated iron pathways. Secondary aims include to assess the efficacy of intravenous iron and measuring potential effects on patients’ physical recovery. AMBLE will be a prospective, parallel-group, double blinded, randomised, multi-centre trial designed to investigate the effects of intravenous iron therapy on disease progression in cardiac, abdominal, and vascular surgery patients. Two separate groups of patients will be assessed: The Perioperative group of patients included if about to undergo major cardiac, abdominal and vascular surgery to assess the mechanisms of iron deficiency in the perioperative period. The Recovery group of patients included 4 weeks after hospital discharge following major cardiac, abdominal and vascular surgery to assess recovery of physical function and anaemia. The outcomes of this research will generate a better understanding of the mechanism of iron deficiency anaemia in surgical patients as well as how this affects post operative recovery. By better understanding the aetiology of iron metabolism in surgery we can determine what intervention (iron +/- EPO) may improve patient outcomes and the administration timing thereof. As a result, more informed decisions will be made regarding iron supplementation and therapy in these patients.