NCT06287619 Post-operative Intravenous Iron to Treat Iron-deficiency Anemia in Patients Undergoing Cardiac Surgery
| NCT ID | NCT06287619 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University Health Network, Toronto |
| Condition | Chronic Iron Deficiency Anaemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-04-03 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 60 participants in total. It began in 2025-04-03 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: Patients who are undergoing any non-emergency open cardiac surgery 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
Contact & Investigator
Justyna Bartoszko, MD
PRINCIPAL INVESTIGATOR
University Health Network, Toronto
Frequently Asked Questions
Who can join the NCT06287619 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Iron Deficiency Anaemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06287619 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06287619 currently recruiting?
Yes, NCT06287619 is actively recruiting participants. Contact the research team at Keyvan.Karkouti@uhn.ca for enrollment information.
Where is the NCT06287619 trial being conducted?
This trial is being conducted at Kingston, Canada, Toronto, Canada, Toronto, Canada.
Who is sponsoring the NCT06287619 clinical trial?
NCT06287619 is sponsored by University Health Network, Toronto. The principal investigator is Justyna Bartoszko, MD at University Health Network, Toronto. The trial plans to enroll 60 participants.