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).
BJA Open
; 11: 100303, 2024 Sep.
Article
in En
| MEDLINE
| ID: mdl-39161801
ABSTRACT
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.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Language:
En
Journal:
BJA Open
Year:
2024
Document type:
Article
Affiliation country:
Canada
Country of publication:
United kingdom