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

February 6, 2026 updated by: University Health Network, Toronto

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Kingston, Ontario, Canada, K7L 3N6
        • Recruiting
        • Kingston Health Sciences Centre
        • Contact:
      • Toronto, Ontario, Canada, M4N 3M5
        • Recruiting
        • Sunnybrook Health Sciences Centre
        • Contact:
      • Toronto, Ontario, Canada, M5G 2C4
        • Recruiting
        • Toronto General Hospital - University Health Network
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 cirrhosis (MELD ≥ 19) or active hepatitis
    6. active infection
  3. 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)
  4. refusal of blood products for religious or other reasons
  5. known pregnancy
  6. already enrolled in this trial
  7. enrolment in another interventional trial which may impact anemia or transfusion management (for example, a trial of hemostatic therapies, such as tranexamic acid)
  8. receipt of intravenous iron at any point in the 6 weeks prior to randomization

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
Patients randomized to the IV iron group will receive 1000 mg ferric derisomaltose (Monoferric) diluted in 100 mL of 0.9 % sodium chloride solution, via intravenous infusion over 1 hour using an opaque IV bag and tubing for blinding.
Drug: Monoferric 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.
Other Names:
  • Ferric derisomaltose
Placebo Comparator: Control group
Patients randomized to the placebo group will receive 100 mL of 0.9 % sodium chloride solution via intravenous infusion using an opaque IV bag and tubing for blinding.
Other: 0.9% 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility Outcome 1: Percentage of major protocol deviations
Time Frame: through study completion, an average of 1 year.
Percentage of major protocol deviations with a feasibility threshold of ≤ 5% (i.e., treatment not according to randomization allocation or dosing schedule; treatment initiated in ineligible patients or outside of allotted periods)
through study completion, an average of 1 year.
Feasibility Outcome 2: Adequate patient enrollment
Time Frame: through study completion, an average of 1 year.
Adequate patient enrollment defined as ≥20% of eligible patients enrolled.
through study completion, an average of 1 year.
Feasibility Outcome 3: Percentage of patients lost to follow-up at 90 days
Time Frame: through study completion, an average of 1 year.
Percentage of patients lost to follow-up at 90 days with a feasibility threshold of ≤ 5%.
through study completion, an average of 1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Collaborators

Sunnybrook Health Sciences Centre
Heart and Stroke Foundation of Canada
Kingston Health Sciences Centre

Investigators

  • Principal Investigator: Justyna Bartoszko, MD, University Health Network, Toronto
  • Principal Investigator: Yulia Lin, MD, Sunnybrook Health Sciences Centre
  • Principal Investigator: Jeannie Callum, MD, Kingston Health Sciences Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 3, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

February 23, 2024

First Submitted That Met QC Criteria

February 23, 2024

First Posted (Actual)

March 1, 2024

Study Record Updates

Last Update Posted (Actual)

February 10, 2026

Last Update Submitted That Met QC Criteria

February 6, 2026

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-5685

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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