Post-operative Intravenous Iron to Treat Iron-deficiency Anemia in Patients Undergoing Cardiac Surgery: A Pilot, Multi-centre, Placebo-controlled Randomized Trial.
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
∙ Patients who are undergoing any non-emergency cardiac surgery with cardiopulmonary bypass (CPB) 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
Locations
Other Locations
Canada
Kingston Health Sciences Centre
NOT_YET_RECRUITING
Kingston
Sunnybrook Health Sciences Centre
RECRUITING
Toronto
Toronto General Hospital - University Health Network
RECRUITING
Toronto
Contact Information
Primary
Keyvan Karkouti, MD
Keyvan.Karkouti@uhn.ca
416-340-4800
Backup
Deep Grewal
Deep.Grewal@uhn.ca
416-340-4800
Time Frame
Start Date:2025-04-03
Estimated Completion Date:2027-06
Participants
Target number of participants:60
Treatments
Experimental: 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.
Placebo_comparator: 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.