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.
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).
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
Patients who are undergoing any non-emergency open cardiac surgery and who meet all following criteria:
1. Age greater than 18 years old
2. Preoperative iron-deficiency with or without anemia (defined as Hb \<130 g/L) with any one of:
1. ferritin ≤100 μg/l; or
2. ferritin ≤ 300 μg/L and transferrin saturation ≤ 20%; or
3. reticulocyte Hb content \< 29 pg, where available
Exclusion Criteria:
Patients who meet any of the following criteria are not eligible for the study:
1. specialized procedures (e.g., ventricular assist device insertion, thoracoabdominal aneurysm, complex adult congenital surgery and heart transplant)
2. established contraindications to IV iron:
1. hypersensitivity to the iron product
2. history of \>2 food and/or drug allergic reactions (excluding drug intolerance)
3. non-iron deficiency anemias such as myelodysplastic syndrome
4. history of iron overload or disturbances in use of iron such as hemochromatosis or hemosiderosis
5. decompensated liver cirrhosis (MELD ≥ 19) or active hepatitis
6. active infection
3. 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)
4. refusal of blood products for religious or other reasons
5. known pregnancy
6. already enrolled in this trial
7. enrolment in another interventional trial which may impact anemia or transfusion management (for example, a trial of hemostatic therapies, such as tranexamic acid)
8. receipt of intravenous iron at any point in the 6 weeks prior to randomization
Primary outcome measure(s)
Feasibility Outcome 1: Percentage of major protocol deviations — through study completion, an average of 1 year. Percentage of major protocol deviations with a feasibility threshold of ≤ 5% (i.e., treatment not according to randomization allocation or dosing schedule; treatment initiated in ineligible patients or outside of allotted periods)
Feasibility Outcome 2: Adequate patient enrollment — through study completion, an average of 1 year. Adequate patient enrollment defined as ≥20% of eligible patients enrolled.
Feasibility Outcome 3: Percentage of patients lost to follow-up at 90 days — through study completion, an average of 1 year. Percentage of patients lost to follow-up at 90 days with a feasibility threshold of ≤ 5%.
Trial sites (3)
Facility
City
Region
Status
Kingston Health Sciences Centre
Kingston
Ontario
Recruiting
Sunnybrook Health Sciences Centre
Toronto
Ontario
Recruiting
Toronto General Hospital - University Health Network
Toronto
Ontario
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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