TerminatedPhase 4ACTRN12622001447741

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

A two-arm, parallel-group double-blind randomisation controlled trial assessing the effect of of intravenous iron versus placebo administration on haemoglobin concentration in anaemic patients undergoing Major cardiac, abdominal, or vascular surgery

Sponsor

South Metropolitan Health Service

Enrollment

40 participants

Start Date

Feb 12, 2023

Study Type

Interventional

Conditions

Vascular Surgery Anaemia

Summary

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.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria6

Perioperative group and Recovery group
Patients who meet the following criteria at the start of treatment are eligible for the study:
Adults (greater than or equal to 18 years)
Undergoing planned or unplanned (elective/expedited or emergent) cardiac surgery (bypass or valve), abdominal surgery (open or laparoscopic) or vascular surgery (open or hybrid) of the lower limb
Anaemia (Hb <130g/L in males and <120g/L) in females
Willing and able to undergo follow-up visits

Exclusion Criteria11

Perioperative group and Recovery group
Patients who, at the start of treatment, meet any of the following criteria are not eligible for the study:
Blood transfusion at operation or blood transfusion in previous 3 months
Erythropoietin or intravenous iron in the previous 4 weeks
Known hypersensitivity to (ferric carboxymaltose or equivalent) or its excipients
Active infection on therapeutic antibiotics
Known chronic liver disease
Known other cause for anaemia (eg. untreated B12 or folate deficiency or myelodysplasia)
Known family history of haemochromatosis or Transferrin saturation (TSATS) >50%
Pregnancy or lactation
Unable to provide written informed consent

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Interventions

Active: Intravenous iron infusion Ferric carboxymaltose 1000 mg given Intravenously Perioperative group: Intravenous iron or placebo will be administered once only immediately postoperatively in

Active: Intravenous iron infusion Ferric carboxymaltose 1000 mg given Intravenously Perioperative group: Intravenous iron or placebo will be administered once only immediately postoperatively in accordance with local hospital guidelines. Adherence will be monitored in accordance with local hospital guidelines. Recovery group: Intravenous iron or placebo will be administered once only 4 weeks post-operatively in accordance with local hospital guidelines. Adherence will be monitored in accordance with local hospital guidelines.