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

NCT ID: NCT06287619

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-03
• Study Completion Date: 2027-06-30

Brief 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.

Conditions

Chronic Iron Deficiency Anaemia; Cardiac Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Monoferric Injectable Product

Intervention Type: 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.

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.

Group Type: PLACEBO_COMPARATOR

0.9% sodium chloride solution

Intervention Type: 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).

Interventions

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).

Intervention Type: OTHER

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.

Intervention Type: DRUG

Other Intervention Names

Ferric derisomaltose

Eligibility Criteria

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) 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kingston Health Sciences Centre

OTHER

Sponsor Role: collaborator

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role: collaborator

Heart and Stroke Foundation of Canada

OTHER

Sponsor Role: collaborator

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Justyna Bartoszko, MD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Jeannie Callum, MD

Role: PRINCIPAL_INVESTIGATOR

Kingston Health Sciences Centre

Yulia Lin, MD

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Health Sciences Centre

Locations

Kingston Health Sciences Centre

Kingston, Ontario, Canada

Site Status: RECRUITING

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Site Status: RECRUITING

Toronto General Hospital - University Health Network

Toronto, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Keyvan Karkouti, MD

Role: CONTACT

Keyvan.Karkouti@uhn.ca

416-340-4800 ext. 8597

Deep Grewal

Role: CONTACT

Deep.Grewal@uhn.ca

416-340-4800 ext. 4221

Facility Contacts

Jeannie Callum, MD BA FRCPC

Role: primary

Jeannie.Callum@kingstonhsc.ca

613-533-6000 ext. 74897

Yulia Lin, MD FRCPC

Role: primary

Yulia.Lin@sunnybrook.ca

(416) 480-4042

Justyna Bartoszko, MD MSc FRCPC

Role: primary

justyna.bartoszko@uhn.ca

416-340-4800 ext. 3243

References

Bartoszko J, Miles S, Ansari S, Grewal D, Li M, Callum J, McCluskey SA, Lin Y, Karkouti K. Postoperative intravenous iron to treat iron-deficiency anaemia in patients undergoing cardiac surgery: a protocol for a pilot, multicentre, placebo-controlled randomized trial (the POAM trial). BJA Open. 2024 Jul 27;11:100303. doi: 10.1016/j.bjao.2024.100303. eCollection 2024 Sep.

Reference Type: DERIVED

PMID: 39161801 (View on PubMed)

Other Identifiers

22-5685

Identifier Type: -

Identifier Source: org_study_id