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Can IV iron boost recovery after heart surgery?

NCT ID NCT06287619

Disease control Sponsor: University Health Network, Toronto Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether giving iron through a vein (IV) after heart surgery helps people with iron-deficiency anemia recover better. About 60 adults having planned open-heart surgery will receive either IV iron or a placebo. The goal is to see if this treatment is practical and improves how many days patients spend alive and out of the hospital within 90 days after surgery.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

iron deficiency anemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cardiac surgery Chronic iron deficiency anaemia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Kingston Health Sciences Centre

    RECRUITING

    Kingston, Ontario, K7L 3N6, Canada

  • Sunnybrook Health Sciences Centre

    RECRUITING

    Toronto, Ontario, M4N 3M5, Canada

  • Toronto General Hospital - University Health Network

    RECRUITING

    Toronto, Ontario, M5G 2C4, Canada

More trials for these conditions

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