Actively Recruiting
Post-operative Intravenous Iron to Treat Iron-deficiency Anemia in Patients Undergoing Cardiac Surgery
Led by University Health Network, Toronto · Updated on 2026-02-10
60
Participants Needed
3
Research Sites
112 weeks
Total Duration
On this page
Sponsors
U
University Health Network, Toronto
Lead Sponsor
K
Kingston Health Sciences Centre
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Post-operative Intravenous Iron to Treat Iron-deficiency Anemia in Patients Undergoing Cardiac Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients undergoing non-emergency open cardiac surgery
- Age greater than 18 years old
- Preoperative iron-deficiency with or without anemia defined as hemoglobin less than 130 g/L and one of the following: ferritin 100 µg/L or less; or ferritin 300 µg/L or less and transferrin saturation 20% or less; or reticulocyte hemoglobin content less than 29 pg where available
You will not qualify if you...
- Undergoing specialized procedures such as ventricular assist device insertion, thoracoabdominal aneurysm repair, complex adult congenital surgery, or heart transplant
- Known hypersensitivity to iron products
- History of more than two food or drug allergic reactions (excluding drug intolerance)
- Having non-iron deficiency anemias such as myelodysplastic syndrome
- History of iron overload or disorders like hemochromatosis or hemosiderosis
- Decompensated liver cirrhosis with MELD score 19 or higher or active hepatitis
- Active infection
- Preoperative unstable hemodynamics requiring vasopressors or inotropes, or active bleeding requiring red blood cell transfusion
- Refusal of blood products for religious or other reasons
- Known pregnancy
- Already enrolled in this trial
- Participation in another interventional trial affecting anemia or transfusion management
- Received intravenous iron within six weeks prior to randomization
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Kingston Health Sciences Centre
Kingston, Ontario, Canada, K7L 3N6
Actively Recruiting
2
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Actively Recruiting
3
Toronto General Hospital - University Health Network
Toronto, Ontario, Canada, M5G 2C4
Actively Recruiting
Research Team
K
Keyvan Karkouti, MD
CONTACT
D
Deep Grewal
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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