Intravenous iron isomaltoside 1000 (Monofer®) reduces postoperative anaemia in preoperatively non-anaemic patients undergoing elective or subacute coronary artery bypass graft, valve replacement or a combination thereof: a randomized double-blind placebo-controlled clinical trial (the PROTECT trial)

P I Johansson, A S Rasmussen, L L Thomsen, P I Johansson, A S Rasmussen, L L Thomsen

Abstract

Background and objectives: This trial explores whether intravenous iron isomaltoside 1000 (Monofer®) results in a better regeneration of haemoglobin levels and prevents anaemia compared to placebo in preoperative non-anaemic patients undergoing cardiac surgery.

Study design and methods: The trial is a prospective, double-blind, comparative, placebo-controlled trial of 60 non-anaemic patients undergoing cardiac surgery. The patients were randomized 1:1 to either 1000 mg intravenous iron isomaltoside 1000 administered perioperatively by infusion or placebo.

Results: Mean preoperative haemoglobin in the active treatment group was 14·3 g/dl vs. 14·0 g/dl in the placebo group. At discharge 5 days after surgery, haemoglobin levels were reduced to 10·7 and 10·5 g/dl, respectively. One month after surgery, haemoglobin concentration had increased to an average of 12·6 g/dl vs. 11·8 g/dl (p = 0·012) and significantly more patients were non-anaemic in the intravenous iron isomaltoside 1000-treated group compared to the placebo group (38·5% vs. 8·0%; p = 0·019). There were no differences in side-effects between the groups.

Conclusion: A single perioperative 1000 mg dose of intravenous iron isomaltoside 1000 significantly increased the haemoglobin level and prevented anaemia 4 weeks after surgery, with a short-term safety profile similar to placebo. Future trials on potential clinical benefits of preoperative treatment with intravenous iron in non-anaemic patients are needed.

Keywords: anaemia; coronary artery bypass surgery; iron.

© 2015 The Authors ISBT Science Series published by John Wiley & Sons Ltd on behalf of International Society of Blood Transfusion.

Figures

Figure 1
Figure 1
Patient disposition.
Figure 2
Figure 2
Response profile of the change in haemoglobin (g/dl) concentration from baseline to 4 weeks with respect to LS mean estimate by treatment group and absolute values (a) Full analysis set, absolute values of haemoglobin. (b) Full analysis set, change in haemoglobin from baseline. (c) Per protocol, absolute values of haemoglobin. (d) Per protocol, change in haemoglobin from baseline.
Figure 3
Figure 3
Transferrin saturation (a), serum ferritin (b) and reticulocyte counts (c) over time by treatment group.
Figure 4
Figure 4
Proportion of non-anaemic patients – full analysis set.

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Source: PubMed

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