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

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

Interventions

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

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).

Sponsors & Collaborators

• Kingston Health Sciences Centre

  collaborator OTHER

• Sunnybrook Health Sciences Centre

  collaborator OTHER

• Heart and Stroke Foundation of Canada

  collaborator OTHER

• University Health Network, Toronto

  lead OTHER

Principal Investigators

• Justyna Bartoszko, MD · University Health Network, Toronto

• Jeannie Callum, MD · Kingston Health Sciences Centre

• Yulia Lin, MD · Sunnybrook Health Sciences Centre

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-04-03

Primary Completion

2026-12-31

Completion

2027-06-30

Countries

• Canada

Study Locations