Using intravenous iron to treat anemia after heart surgery

Post-operative Intravenous Iron to Treat Iron-deficiency Anemia in Patients Undergoing Cardiac Surgery: A Pilot, Multi-centre, Placebo-controlled Randomized Trial.

This study is testing if giving intravenous iron to patients with anemia after heart surgery can help them stay out of the hospital and feel better.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Health Network, Toronto (Academic / other)
• Locations: 3 sites (Kingston, Ontario and 2 other locations)
• Trial ID: NCT06287619 on ClinicalTrials.gov

What this trial studies

This multicenter, randomized, controlled pilot trial aims to evaluate the feasibility of a larger study investigating the effects of intravenous iron therapy on patients with chronic iron-deficiency anemia undergoing cardiac surgery. Participants will receive either the iron treatment or a placebo shortly after surgery, with a follow-up dose at 42 days if necessary. The primary outcome measure will be the number of days alive and out of the hospital within 90 days post-surgery. The trial is being conducted at three cardiac surgery centers in Canada.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 years old with preoperative iron-deficiency anemia scheduled for non-emergency cardiac surgery involving cardiopulmonary bypass.

Not a fit: Patients with contraindications to intravenous iron or those undergoing specialized cardiac procedures may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve recovery outcomes for patients with anemia undergoing cardiac surgery.

How similar studies have performed: Previous studies have shown promising results with intravenous iron therapy in similar patient populations, suggesting potential for success in this approach.

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

Where this trial is running

Kingston, Ontario and 2 other locations

• Kingston Health Sciences Centre — Kingston, Ontario, Canada (Recruiting)
• Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada (Recruiting)
• Toronto General Hospital - University Health Network — Toronto, Ontario, Canada (Recruiting)

Study contacts

• Principal investigator: Justyna Bartoszko, MD — University Health Network, Toronto
• Study coordinator: Keyvan Karkouti, MD

Conditions Chronic Iron Deficiency Anaemia; Cardiac Surgery; Ferric derisomaltose; Intravenous Iron