Clinical trial 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?
This is an investigational iron medicine being studied to see if it helps people with chronic iron deficiency anemia after heart surgery. It is designed to provide iron directly into the bloodstream to help the body make red blood cells.
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
- This study is testing whether giving IV iron after heart surgery helps people with iron‑deficiency anemia stay alive and out of the hospital for 90 days. It compares iron to a pretend treatment with no medicine.
- Who it's for
- You may be able to join if you have iron‑deficiency anemia and are having heart surgery at one of the three Canadian hospitals.
- What's involved
- You will receive an IV iron injection soon after surgery and possibly a second one 42 days later if needed. You will also have regular check‑ins and tests to see how you are doing.
- Time commitment
- The study lasts about 90 days after surgery, with visits and tests during that time.
- 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
- Age greater than 18 years old
- ferritin ≤100 μg/l; or
- ferritin ≤ 300 μg/L and transferrin saturation ≤ 20%; or
- reticulocyte Hb content \< 29 pg, where available
You likely can't join if
- specialized procedures (e.g., ventricular assist device insertion, thoracoabdominal aneurysm, complex adult congenital surgery and heart transplant)
- 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
See the full eligibility criteria
- Age greater than 18 years old
- ferritin ≤100 μg/l; or
- ferritin ≤ 300 μg/L and transferrin saturation ≤ 20%; or
- reticulocyte Hb content \< 29 pg, where available
- specialized procedures (e.g., ventricular assist device insertion, thoracoabdominal aneurysm, complex adult congenital surgery and heart transplant)
- 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 is enrolling
- Kingston, Ontario, Canada
- Toronto, Ontario, Canada
Compensation & support
A stipend or payment for your time may be offered.
No amount is published here because ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
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, so 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, but 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?
This study is enrolling now at Kingston, Ontario, Canada; Toronto, Ontario, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.