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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
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.
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).
Kingston Health Sciences Centre
Kingston, Ontario, Canada
RECRUITINGSunnybrook Health Sciences Centre
Toronto, Ontario, Canada
RECRUITINGToronto General Hospital - University Health Network
Toronto, Ontario, Canada
RECRUITINGFeasibility Outcome 1: Percentage of major protocol deviations
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)
Time frame: through study completion, an average of 1 year.
Feasibility Outcome 2: Adequate patient enrollment
Adequate patient enrollment defined as ≥20% of eligible patients enrolled.
Time frame: through study completion, an average of 1 year.
Feasibility Outcome 3: Percentage of patients lost to follow-up at 90 days
Percentage of patients lost to follow-up at 90 days with a feasibility threshold of ≤ 5%.
Time frame: through study completion, an average of 1 year.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.