Post-operative Intravenous Iron to Treat Iron-deficiency Anemia in Patients Undergoing Cardiac Su… (NCT06287619) | Clinical Trial Compass
RecruitingPhase 2
Post-operative Intravenous Iron to Treat Iron-deficiency Anemia in Patients Undergoing Cardiac Surgery
Canada60 participantsStarted 2025-04-03
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion 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
✕. 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
What they're measuring
1
Feasibility Outcome 1: Percentage of major protocol deviations
Timeframe: through study completion, an average of 1 year.