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NCT Number: NCT06287619

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Kingston Health Sciences Centre, Kingston, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients who are undergoing any non-emergency open cardiac surgery and who meet all following 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

Patients who meet any of the following criteria are not eligible for the study:

  • 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
  • history of iron overload or disturbances in use of iron such as hemochromatosis or hemosiderosis
  • decompensated liver cirrhosis (MELD ≥ 19) or active hepatitis
  • active infection
  • 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)
  • refusal of blood products for religious or other reasons
  • known pregnancy
  • already enrolled in this trial
  • enrolment in another interventional trial which may impact anemia or transfusion management (for example, a trial of hemostatic therapies, such as tranexamic acid)
  • receipt of intravenous iron at any point in the 6 weeks prior to randomization

Treatment and study plan

Monoferric Injectable Product

Drug

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

0.9% sodium chloride solution

Other

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).

Primary outcomes

  1. 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)

  2. 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.

  3. 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%.

Study contacts

Contact information is provided by the study sponsor or research team.

Deep Grewal

CONTACT

[email protected]

416-340-4800 ext. 4221

Keyvan Karkouti, MD

CONTACT

[email protected]

416-340-4800 ext. 8597

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

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

Registry information

Official study title

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

Acronym: POAM

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Mar 1, 2024
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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