Post-operative Intravenous Iron to Treat Iron-deficiency Anemia in Patients Undergoing Cardiac Surgery

Launched by UNIVERSITY HEALTH NETWORK, TORONTO · Feb 23, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring whether giving intravenous (IV) iron to patients with chronic iron-deficiency anemia after cardiac surgery can improve their recovery. Specifically, the study will look at whether this treatment helps patients spend more days alive and out of the hospital within 90 days after their surgery compared to those who receive a placebo (a treatment that looks like the real thing but has no active ingredients). The trial is being conducted at three cardiac surgery centers in Canada and is currently recruiting participants.

To be eligible for this study, participants must be adults over 18 years old who are scheduled for non-emergency heart surgery and have been diagnosed with iron-deficiency anemia. This condition is typically confirmed by low hemoglobin levels and other specific blood test results. However, certain patients, such as those with specific heart conditions, severe allergies to iron, or other serious health issues, will not be able to participate. If enrolled, participants can expect to receive either the IV iron treatment or a placebo shortly after their surgery and possibly again about six weeks later, depending on their needs.

Gender

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Eligibility criteria

• Inclusion Criteria:
• Patients who are undergoing any non-emergency cardiac surgery with cardiopulmonary bypass (CPB) 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 ≤ 300 μg/L and transferrin saturation ≤ 20%; or
• • 2. 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