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)

• Published in: Vox sanguinis 2015-10, Vol.109 (3), p.257-266
• Main Authors: Johansson, P. I., Rasmussen, A. S., Thomsen, L. L.
• Format: Article
• Language: English
• Subjects: Aged; Aged, 80 and over; anaemia; Anemia - drug therapy; Coronary Artery Bypass; coronary artery bypass surgery; Coronary Disease - surgery; Disaccharides - therapeutic use; Double-Blind Method; Elective Surgical Procedures; Female; Ferric Compounds - therapeutic use; Hemoglobins - analysis; Humans; iron; Male; Middle Aged; Placebo Effect; Postoperative Complications; Prospective Studies; Transfusion Medicine and New Therapies; Treatment Outcome
• ISSN: 0042-9007; 1423-0410
• DOI: 10.1111/vox.12278

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.