Post-operative Intravenous Iron to Treat Iron-deficiency Anemia in Patients Undergoing Cardiac Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Monoferric Injectable Product, 0.9% sodium chloride solution.
- Who it may be relevant to
- Registry conditions: Chronic Iron Deficiency Anaemia, Cardiac Surgery. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Post-operative Intravenous Iron to Treat Iron-deficiency Anemia in Patients Undergoing Cardiac Surgery: A Pilot, Multi-centre, Placebo-controlled Randomized Trial.
Overview
POAM is a multicenter, randomized, controlled, internal pilot trial, using a conventional, parallel group, two-armed design at 3 cardiac surgery centres in Canada. The study is designed to assess the feasibility of a future, definitive RCT investigating whether, in patients with chronic iron-deficiency anemia undergoing cardiac surgery, IV iron therapy in the postoperative period (initiated shortly after surgery, and repeated at 42 days after surgery, if needed) improves clinical outcomes (days alive and out of hospital at 90 days after surgery; DAOH-90) relative to placebo.
Interventions
- Drug Monoferric Injectable Product
Ferric derisomaltose will be prepared by an unblinded research pharmacist/delegated staff as per standard of care procedures. Specifically, 10 mL (containing 1000 mg ferric derisomaltose) will be diluted in 100 mL of sterile 0.9% sodium chloride solution and drawn up into blinded syringes and tubing. The 1000 mg doses of ferric derisomaltose will be administered by a bedside nurse over 60 minutes via an infusion pump through a dedicated IV. - Other 0.9% sodium chloride solution
Patients in the control group will receive placebo, which will be 100 mL of sterile 0.9% sodium chloride solution and drawn up into blinded syringes and tubing according to good manufacturing practice (GMP).
Primary outcome measures
- Feasibility Outcome 1: Percentage of major protocol deviations [Time frame: through study completion, an average of 1 year.]
- Feasibility Outcome 2: Adequate patient enrollment [Time frame: through study completion, an average of 1 year.]
- Feasibility Outcome 3: Percentage of patients lost to follow-up at 90 days [Time frame: through study completion, an average of 1 year.]
Eligibility criteria
Inclusion criteria
Patients who are undergoing any non-emergency open cardiac surgery and who meet all following criteria:
- Age greater than 18 years old
- Preoperative iron-deficiency with or without anemia (defined as Hb <130 g/L) with any one of:
- ferritin ≤100 μg/l; or
- ferritin ≤ 300 μg/L and transferrin saturation ≤ 20%; or
- reticulocyte Hb content < 29 pg, where available
Exclusion criteria
Patients who meet any of the following criteria are not eligible for the study:
- specialized procedures (e.g., ventricular assist device insertion, thoracoabdominal aneurysm, complex adult congenital surgery and heart transplant)
- established contraindications to IV iron:
- hypersensitivity to the iron product
- history of >2 food and/or drug allergic reactions (excluding drug intolerance)
- non-iron deficiency anemias such as myelodysplastic syndrome
- history of iron overload or disturbances in use of iron such as hemochromatosis or hemosiderosis
- decompensated liver cirrhosis (MELD ≥ 19) or active hepatitis
- active infection
- preoperative unstable hemodynamics defined as the requirement for vasopressors or inotropes, or active bleeding (as noted in the clinical record and/or defined as a requirement for red blood cell transfusion for ongoing clinical bleeding)
- refusal of blood products for religious or other reasons
- known pregnancy
- already enrolled in this trial
- enrolment in another interventional trial which may impact anemia or transfusion management (for example, a trial of hemostatic therapies, such as tranexamic acid)
- receipt of intravenous iron at any point in the 6 weeks prior to randomization
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Canada · 3 centers
- Kingston Health Sciences Centre — Kingston
- Sunnybrook Health Sciences Centre — Toronto
- Toronto General Hospital - University Health Network — Toronto
Publications
- Bartoszko J, Miles S, Ansari S, Grewal D, Li M, Callum J, McCluskey SA, Lin Y, Karkouti K. 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. 2024 Jul 27;11:100303. doi: 10.1016/j.bjao.2024.100303. eCollection 2024 Sep. PMID 39161801
Identifiers
NCT: NCT06287619 · 22-5685