Postoperative intravenous iron to treat iron-deficiency anaemia in patients undergoing cardiac surgery: a protocol for a pilot, multicentre, placebo-controlled randomized trial (the POAM trial)
Justyna Bartoszko,
Sarah Miles,
Saba Ansari,
Deep Grewal,
Michelle Li,
Jeannie Callum,
Stuart A. McCluskey,
Yulia Lin,
Keyvan Karkouti
Affiliations
Justyna Bartoszko
Institute of Medical Science, University of Toronto, Toronto, ON, Canada; Department of Anesthesia and Pain Management, Sinai Health System, Women's College Hospital, University Health Network, Toronto, ON, Canada; Department of Anesthesiology and Pain Medicine, University of Toronto, Toronto, ON, Canada; Peter Munk Cardiac Centre, University Health Network, Toronto, ON, Canada; University of Toronto Quality in Utilization, Education and Safety in Transfusion Research Program, Toronto, ON, Canada; Corresponding author. Institute of Medical Science, University of Toronto, Toronto, ON, Canada.
Sarah Miles
Department of Anesthesia and Pain Management, Sinai Health System, Women's College Hospital, University Health Network, Toronto, ON, Canada
Saba Ansari
Department of Anesthesia and Pain Management, Sinai Health System, Women's College Hospital, University Health Network, Toronto, ON, Canada; Department of Anesthesiology and Pain Medicine, University of Toronto, Toronto, ON, Canada
Deep Grewal
Department of Anesthesia and Pain Management, Sinai Health System, Women's College Hospital, University Health Network, Toronto, ON, Canada; Department of Anesthesiology and Pain Medicine, University of Toronto, Toronto, ON, Canada
Michelle Li
Institute of Medical Science, University of Toronto, Toronto, ON, Canada; Department of Anesthesia and Pain Management, Sinai Health System, Women's College Hospital, University Health Network, Toronto, ON, Canada
Jeannie Callum
University of Toronto Quality in Utilization, Education and Safety in Transfusion Research Program, Toronto, ON, Canada; Department of Pathology and Molecular Medicine, Kingston Health Sciences Centre and Queen's University, Kingston, ON, Canada
Stuart A. McCluskey
Department of Anesthesia and Pain Management, Sinai Health System, Women's College Hospital, University Health Network, Toronto, ON, Canada; Department of Anesthesiology and Pain Medicine, University of Toronto, Toronto, ON, Canada; Peter Munk Cardiac Centre, University Health Network, Toronto, ON, Canada
Yulia Lin
University of Toronto Quality in Utilization, Education and Safety in Transfusion Research Program, Toronto, ON, Canada; Precision Diagnostics and Therapeutics Program, Sunnybrook Health Sciences Centre, Toronto, ON, Canada; Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, ON, Canada
Keyvan Karkouti
Institute of Medical Science, University of Toronto, Toronto, ON, Canada; Department of Anesthesia and Pain Management, Sinai Health System, Women's College Hospital, University Health Network, Toronto, ON, Canada; Department of Anesthesiology and Pain Medicine, University of Toronto, Toronto, ON, Canada; Peter Munk Cardiac Centre, University Health Network, Toronto, ON, Canada; University of Toronto Quality in Utilization, Education and Safety in Transfusion Research Program, Toronto, ON, Canada; Institute for Health Policy, Management, and Evaluation, University of Toronto, Toronto, ON, Canada; Interdepartmental Division of Critical Care, Department of Medicine, University of Toronto, Toronto, ON, Canada
Background: Iron-deficiency anaemia, occurring in 30–40% of patients undergoing cardiac surgery, is an independent risk factor for adverse outcomes. Our long-term goal is to assess if postoperative i.v. iron therapy improves clinical outcomes in patients with preoperative iron-deficiency anaemia undergoing cardiac surgery. Before conducting a definitive RCT, we first propose a multicentre pilot trial to establish the feasibility of the definitive trial. Methods: This internal pilot, double-blinded, RCT will include three centres. Sixty adults with preoperative iron-deficiency anaemia undergoing non-emergency cardiac surgery will be randomised on postoperative day 2 or 3 to receive either blinded i.v. iron (1000 mg ferric derisomaltose) or placebo. Six weeks after surgery, patients who remain iron deficient will receive a second blinded dose of i.v. iron according to their assigned treatment arm. Patients will be followed for 12 months. Clinical practice will not be otherwise modified. For the pilot study, feasibility will be assessed through rates of enrolment, protocol deviations, and loss to follow up. For the definitive study, the primary outcome will be the number of days alive and out of hospital at 90 days after surgery. Ethics and dissemination: The trial has been approved by the University Health Network Research Ethics Board (REB # 22-5685; approved by Clinical Trials Ontario funding on 22 December 2023) and will be conducted in accordance with the Declaration of Helsinki, Good Clinical Practices guidelines, and regulatory requirements. Clinical trial registration: NCT06287619.
