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

Last updated: June 9, 2025
Sponsor: University Health Network, Toronto
Overall Status: Active - Recruiting

Phase

2

Condition

Cardiac Surgery

Anemia

Treatment

0.9% sodium chloride solution

Monoferric Injectable Product

Clinical Study ID

NCT06287619
22-5685
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

Patients who are undergoing any non-emergency cardiac surgery with cardiopulmonary bypass (CPB) 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) withany one of:

  3. ferritin ≤ 300 μg/L and transferrin saturation ≤ 20%; or

  4. reticulocyte Hb content < 29 pg, where available

Exclusion

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, thoracoabdominalaneurysm, complex adult congenital surgery and heart transplant)

  2. established contraindications to IV iron:

  3. hypersensitivity to the iron product

  4. history of >2 food and/or drug allergic reactions (excluding drug intolerance)

  5. non-iron deficiency anemias such as myelodysplastic syndrome

  6. history of iron overload or disturbances in use of iron such as hemochromatosisor hemosiderosis

  7. decompensated liver cirrhosis (MELD ≥ 19) or active hepatitis

  8. active infection

  9. preoperative unstable hemodynamics defined as the requirement for vasopressors orinotropes, or active bleeding (as noted in the clinical record and/or defined as arequirement for red blood cell transfusion for ongoing clinical bleeding)

  10. refusal of blood products for religious or other reasons

  11. known pregnancy

  12. already enrolled in this trial

  13. enrolment in another interventional trial which may impact anemia or transfusionmanagement (for example, a trial of hemostatic therapies, such as tranexamic acid)

  14. receipt of intravenous iron at any point in the 6 weeks prior to randomization

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: 0.9% sodium chloride solution
Phase: 2
Study Start date:
April 03, 2025
Estimated Completion Date:
June 30, 2027

Connect with a study center

  • Kingston Health Sciences Centre

    Kingston, Ontario K7L 3N6
    Canada

    Site Not Available

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario M4N 3M5
    Canada

    Active - Recruiting

  • Toronto General Hospital - University Health Network

    Toronto, Ontario M5G 2C4
    Canada

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.