title: 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).
abstract: OBJECTIVE
  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.
  
  
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Clinical Immunology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
authors.forename: P I
authors.initials: PI
authors.lastname: Johansson
authors.affiliation: Department of Clinical Immunology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
authors.forename: A S
authors.initials: AS
authors.lastname: Rasmussen
authors.affiliation: Pharmacosmos A/S, Holbaek, Denmark.
authors.forename: L L
authors.initials: LL
authors.lastname: Thomsen
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000740:Anemia / Q000188:drug therapy*; D001026:Coronary Artery Bypass; D003327:Coronary Disease / Q000601:surgery*; D004187:Disaccharides / Q000627:therapeutic use*; D004311:Double-Blind Method; D017558:Elective Surgical Procedures; D005260:Female; D005290:Ferric Compounds / Q000627:therapeutic use*; D006454:Hemoglobins / Q000032:analysis; D006801:Humans; D008297:Male; D008875:Middle Aged; D015990:Placebo Effect; D011183:Postoperative Complications; D011446:Prospective Studies; D016896:Treatment Outcome
chemical_list: D004187:Disaccharides; D005290:Ferric Compounds; D006454:Hemoglobins; C557707:iron isomaltoside 1000
keywords: anaemia; coronary artery bypass surgery; iron