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Iron boost before heart surgery may cut need for donor blood

NCT ID NCT06637137

Prevention Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 10, 2026 · Last updated Sep 11, 2026 · Updated 1 time

Summary

Researchers are testing whether giving intravenous iron, along with folic acid and B vitamins, before planned heart surgery can lower the number of blood transfusions patients need. The study includes 464 adults scheduled for elective cardiac surgery. Doctors check patients' blood tests for low iron and treat those who have it at least two weeks before surgery, then track how many red blood cell units are given during and after the operation.

What this could mean

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

Active substance
intravenous iron given with folic acid and B vitamins before heart surgery
What this could lead to
If it works, this could give heart surgery patients a simple way to lower their need for donor blood transfusions and avoid related risks.
What could go wrong
The trial may show that iron infusions do not reduce transfusions enough to matter, or that the approach is not worth the cost. Iron infusions can cause side effects, and results in this group may not apply to everyone.

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.

Participants

About 464 people

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

Started

Feb 2025

Expected to finish

Feb 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.

Who is studied

All patients candidate for elective cardiac surgery at our tertiary care hospital are eligible for the study purpose.

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: \- all adult patients scheduled for elective cardiac surgery Exclusion Criteria: * pregnancy * dyalisis * patient's refusal

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Conditions

The condition(s) this trial relates to.

anemia Blood Loss, Surgical iron deficiency anemia

As listed by the trial registrant

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

Anemia Anemia, iron-deficiency Blood loss, surgical Cardiac surgical patients Iron deficiency anemia (IDA) Iron deficiency anemia treatment

How to take part

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

  1. The places running it

    1 site. 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

  • Fondazione Policlinico Gemelli IRCCS

    RECRUITING

    Roma, 00100, Italy

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