Post-operative Intravenous Iron to Treat Iron-deficiency Anemia in Patients Undergoing Cardiac Surgery
Trial Parameters
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
Brief 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 Criteria
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