title: PREVENTT: preoperative intravenous iron to treat anaemia in major surgery: study protocol for a randomised controlled trial.
abstract: BACKGROUND
  Anaemia is common in patients undergoing major surgery. The current standard of care for patients with low haemoglobin in the peri-operative period is blood transfusion. The presence of preoperative anaemia is associated with an increased likelihood of the patient receiving peri-operative transfusion and worsened outcomes following surgery, more post-operative complications, delayed recovery and greater length of hospital stay. Intravenous iron, if applied in the preoperative setting, may correct anaemia by the time of surgery and reduce the need for blood transfusion and improve outcomes.
  
  
  METHODS
  PREVENTT is a phase III double-blind randomised controlled trial that will compare the use of intravenous ferric carboxymaltose (dose 1000 mg) with placebo 10-42 days before major open abdominal surgery in 500 patients with anaemia (haemoglobin < 120 g/L). The primary outcome measure will be the need for blood transfusion and secondary endpoints will include post-operative recovery, length of hospital stay, health care utilisation and cost analysis.
  
  
  BACKGROUND
  ISRCTN67322816--registered 9 October 2012. ClinicalTrials.gov identifier: NCT01692418.
authors.affiliation: Division of Surgery and Interventional Science, University College London, London, UK. toby.richards@ucl.ac.uk.
authors.forename: Toby
authors.initials: T
authors.lastname: Richards
authors.affiliation: Division of Surgery and Interventional Science, University College London, London, UK. b.clevenger@nhs.net.|Division of Surgery and Interventional Science, 4th Floor, UCL Medical School Building, 21 University Street, University College London, London, WC1E 6AU, UK. b.clevenger@nhs.net.
authors.forename: Ben
authors.initials: B
authors.lastname: Clevenger
authors.affiliation: Consultant Haematologist (retired), Queen Elizabeth Hospital, King's Lynn NHS Trust, Suffolk, UK. ajkeidan@btinternet.com.
authors.forename: Jane
authors.initials: J
authors.lastname: Keidan
authors.affiliation: Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, UK. timothy.collier@lshtm.ac.uk.
authors.forename: Tim
authors.initials: T
authors.lastname: Collier
authors.affiliation: Department of Anaesthesia and Intensive Care, Papworth Hospital, Cambridge, UK. andrew.klein@nhs.net.
authors.forename: Andrew A
authors.initials: AA
authors.lastname: Klein
authors.affiliation: Department of Innovative Clinical Trials, University Medical Centre Göttingen (UMG), Göttingen, Germany. s.anker@cachexia.de.
authors.forename: Stefan D
authors.initials: SD
authors.lastname: Anker
authors.affiliation: Division of Surgery and Interventional Science, University College London, London, UK. j.d.kelly@ucl.ac.uk.
authors.forename: John D
authors.initials: JD
authors.lastname: Kelly
mesh_terms: D000005:Abdomen / Q000601:surgery*; D061605:Administration, Intravenous; D000740:Anemia / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy* / Q000191:economics; D015415:Biomarkers / Q000097:blood; D001803:Blood Transfusion; D002985:Clinical Protocols; D003362:Cost-Benefit Analysis; D004311:Double-Blind Method; D016527:Drug Costs; D004739:England; D005290:Ferric Compounds / Q000008:administration & dosage* / Q000009:adverse effects / Q000191:economics; D006295:Health Resources / Q000191:economics / Q000706:statistics & numerical data; D006397:Hematinics / Q000008:administration & dosage* / Q000009:adverse effects / Q000191:economics; D006454:Hemoglobins / Q000378:metabolism; D017721:Hospital Costs; D006801:Humans; D007902:Length of Stay; D008320:Maltose / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000191:economics; D011300:Preoperative Care; D020127:Recovery of Function; D012107:Research Design; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D015415:Biomarkers; D005290:Ferric Compounds; D006397:Hematinics; D006454:Hemoglobins; C522335:ferric carboxymaltose; D008320:Maltose