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A randomised double-blind controlled phase III study to compare the efficacy and safety of intravenous ferric carboxymaltose with placebo in patients with anaemia undergoing major open abdominal surgery.

 

Primary Objective: To determine if a single dose of intravenous iron (ferric carboxymaltose; 1000mg) given to patients with anaemia prior to major open abdominal surgery reduces the need for peri-operative blood transfusion. For the purpose of this trial the peri-operative period is defined as from randomisation to until 30 days following operation.

Secondary Objectives:

  • To evaluate the effect of intravenous ferric carboxymaltose (Ferinject®) compared with placebo on change in haemoglobin levels
  • To evaluate the effect of intravenous ferric carboxymaltose (Ferinject®) compared with placebo on post-operative morbidity, length of hospital stay and mortality.
  • To evaluate the effect of intravenous ferric carboxymaltose (Ferinject®) compared with placebo on health related quality of life.
  • To evaluate resource use and costs associated with the treatment with intravenous ferric carboxymaltose (Ferinject®)compared with placebo.
  • To evaluate the tolerability and safety of Ferinject® compared with placebo from randomisation till study termination.
  • To evaluate the effect of intravenous ferric carboxymaltose (Ferinject®) compared with placebo on:
    • Complications of the intervention itself
    • Complications from blood transfusion or blood products