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Can a simple iron infusion before heart surgery speed up recovery?

NCT ID NCT02632760

Disease control Sponsor: Bayside Health Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tested whether giving an intravenous iron infusion to anemic patients before elective heart surgery helps them recover faster. Nearly 1,000 adults with anemia received either IV iron or a placebo 1 to 10 weeks before their surgery. The main goal was to see if the iron treatment increased the number of days patients were alive and out of the hospital within 90 days after surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Ferric carboxymaltose (IV iron)
What this could lead to
If it works, this could become a standard way to treat anemia before heart surgery, helping patients recover more quickly and spend less time in the hospital.
What could go wrong
This is a completed phase 4 trial, so results are already available. However, IV iron may not benefit all anemic patients and carries a small risk of allergic reactions or side effects.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

955 people

The number who actually took part.

Started

Jul 2016

Finished

Nov 2024

Lead sponsor

A government agency

The lead sponsor is a government body.

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 with anaemia (males Hb \<130 g/L, females \<120 g/L) undergoing elective cardiac surgery, and available to receive trial drug 1- 10 weeks prior to surgery Exclusion Criteria: * Pregnancy * Known hypersensitivity to study drug (ferric carboxymaltose or equivalent) or its excipients * Known or suspected haemoglobinopathy/thalassaemia * Bone marrow disease * Haemochromatosis * Renal dialysis * Erythropoietin or IV iron in the previous 4 weeks

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Conditions

The condition(s) this trial relates to.

anemia

As listed by the trial registrant

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

Anaemia

Contacts and locations

Locations

  • Alfred Health

    Melbourne, Victoria, 3181, Australia

More trials for these conditions

Other studies related to the condition(s) this trial covers.