Home
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
