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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)
Johansson PI, Rasmussen AS, Thomsen LL
Vox Sanguinis. 2015;109((3)):257-66.
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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 143 g/dl vs. 140 g/dl in the placebo group. At discharge 5 days after surgery, haemoglobin levels were reduced to 107 and 105 g/dl, respectively. One month after surgery, haemoglobin concentration had increased to an average of 126 g/dl vs. 118 g/dl (p = 0012) and significantly more patients were non-anaemic in the intravenous iron isomaltoside 1000-treated group compared to the placebo group (385% vs. 80%; p = 0019). 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.Copyright © 2015 The Authors ISBT Science Series published by John Wiley & Sons Ltd on behalf of International Society of Blood Transfusion.