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New treatment option for Chronic Iron Deficiency Anaemia
Official title Post-operative Intravenous Iron to Treat Iron-deficiency Anemia in Patients Undergoing Cardiac Surgery
ClinicalTrials.gov ID: NCT06287619
What this study is testing
What is Monoferric Injectable Product?
Monoferric Injectable Product is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for chronic iron deficiency anaemia.
Also referred to as Ferric derisomaltose.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients who are undergoing any non-emergency open cardiac surgery 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
You likely can't join if
- Patients who meet any of the following criteria are not eligible for the study:
- specialized procedures (e.g., ventricular assist device insertion, thoracoabdominal aneurysm, complex adult congenital surgery and heart transplant)
- established contraindications to IV iron:
- hypersensitivity to the iron product
- history of \>2 food and/or drug allergic reactions (excluding drug intolerance)
- non-iron deficiency anemias such as myelodysplastic syndrome
See the full eligibility criteria
- Patients who are undergoing any non-emergency open cardiac surgery 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
- Patients who meet any of the following criteria are not eligible for the study:
- specialized procedures (e.g., ventricular assist device insertion, thoracoabdominal aneurysm, complex adult congenital surgery and heart transplant)
- established contraindications to IV iron:
- hypersensitivity to the iron product
- history of \>2 food and/or drug allergic reactions (excluding drug intolerance)
- non-iron deficiency anemias such as myelodysplastic syndrome
- history of iron overload or disturbances in use of iron such as hemochromatosis or hemosiderosis
- decompensated liver cirrhosis (MELD ≥ 19) or active hepatitis
- active infection
- 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...
- refusal of blood products for religious or other reasons
- known pregnancy
- already enrolled in this trial
- enrolment in another treatment trial which may impact anemia or transfusion management (for example, a trial of hemostatic therapies, such as tranexamic acid)
- receipt of intravenous iron at any point in the 6 weeks prior to randomization
The study team makes the final eligibility decision.
Where it's taking place
- Kingston, Ontario, Canada
- Toronto, Ontario, Canada
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kingston, Ontario, Canada; Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.