RecruitingPhase 2NCT06287619

Post-operative Intravenous Iron to Treat Iron-deficiency Anemia in Patients Undergoing Cardiac Surgery

Post-operative Intravenous Iron to Treat Iron-deficiency Anemia in Patients Undergoing Cardiac Surgery: A Pilot, Multi-centre, Placebo-controlled Randomized Trial.

Sponsor

University Health Network, Toronto

Enrollment

60 participants

Start Date

Apr 3, 2025

Study Type

INTERVENTIONAL

Conditions

Cardiac Surgery Chronic Iron Deficiency Anaemia

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

Min Age: 18 Years

Inclusion Criteria6

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 Criteria15

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

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Interventions

DRUGMonoferric 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.

OTHER0.9% 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).