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

PHASE2RecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

April 3, 2025

Primary Completion Date

December 31, 2026

Study Completion Date

June 30, 2027

Conditions
Chronic Iron Deficiency AnaemiaCardiac 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).

Trial Locations (3)

K7L 3N6

NOT_YET_RECRUITING

Kingston Health Sciences Centre, Kingston

M4N 3M5

RECRUITING

Sunnybrook Health Sciences Centre, Toronto

M5G 2C4

RECRUITING

Toronto General Hospital - University Health Network, Toronto

All Listed Sponsors
collaborator

Kingston Health Sciences Centre

OTHER

collaborator

Sunnybrook Health Sciences Centre

OTHER

collaborator

Heart and Stroke Foundation of Canada

OTHER

lead

University Health Network, Toronto

OTHER