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).

Autor:	Bartoszko J; 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., Miles S; Department of Anesthesia and Pain Management, Sinai Health System, Women's College Hospital, University Health Network, Toronto, ON, Canada., Ansari S; 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., Grewal D; 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., Li M; 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., Callum J; 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., McCluskey SA; 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., Lin Y; 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., Karkouti K; 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.
Jazyk:	angličtina
Zdroj:	BJA open [BJA Open] 2024 Jul 27; Vol. 11, pp. 100303. Date of Electronic Publication: 2024 Jul 27 (Print Publication: 2024).
DOI:	10.1016/j.bjao.2024.100303
Abstrakt:	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. Competing Interests: JB is supported in part by a merit award from the 10.13039/100031443Department of Anesthesiology and Pain Medicine, 10.13039/501100003579University of Toronto, and has received funding or honoraria from Octapharma, Grifols, and Canadian Blood Services. KK is supported in part by a merit award from the 10.13039/100031443Department of Anesthesiology and Pain Medicine, 10.13039/501100003579University of Toronto, and has received research support, honoraria, or consultancy for speaking engagements from Octapharma, 10.13039/100006353Instrumentation Laboratory, and 10.13039/100004326Bayer. JC has received research support from 10.13039/501100000014Canadian Blood Services and Octapharma. YL has received research support from 10.13039/501100000014Canadian Blood Services and Octapharma, and is a consultant with Choosing Wisely Canada. (© 2024 The Authors.)
Databáze:	MEDLINE
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