Using intravenous iron to treat anemia after heart surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: Keyvan.Karkouti@uhn.ca
• Phone: 416-340-4800

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Impact of Fast-Track Anesthesia on Postoperative Delirium After Cardiac Surgery

  This observational study tests whether fast-track anesthesia, compared with conventional care, is linked to lower rates of delirium after elective cardiac surgery in adults.

  Recruiting Second Affiliated Hospital of Nanchang University · Nanchang, Jiangxi · NCT07923344

• Sarcopenia in Patients After Cardiac Surgery

  This observational study tests how common sarcopenia is after cardiac surgery and whether current care helps improve muscle mass and function.

  Recruiting Universitaire Ziekenhuizen KU Leuven · Leuven · NCT07908472

• Preoperative functional optimization for adults undergoing major cardiac or abdominal surgery

  This study tests a four‑week prehabilitation program to improve fitness before elective major cardiac or abdominal surgery.

  Recruiting ASST Sette Laghi · Varese, VA and 1 other locations · NCT07851350

• Oral Extubation Right After Cardiac Surgery

  This trial tests whether waking patients and removing the breathing tube in the operating room after elective cardiac surgery helps recovery more quickly without added risk.

  Recruiting Massachusetts General Hospital · Boston, Massachusetts and 1 other locations · NCT07757880

• Frailty and Ultrasound-Guided Catheterization in Adult Cardiac Surgery Patients

  This study tests whether frailty and ultrasound measurements taken before surgery can predict how difficult it will be to place an ultrasound-guided internal jugular venous catheter in adults undergoing elective cardiac surgery.

  Recruiting Ankara City Hospital Bilkent · Ankara, Ankara · NCT07701538

• Prehabilitation before heart surgery for adults with congenital heart disease

  This study is testing whether a tailored, supervised exercise program before heart surgery helps adults with congenital heart disease perform better and improve fitness.

  Recruiting Liverpool Heart and Chest Hospital NHS Foundation Trust · Liverpool · NCT07700459

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.