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Could a simple iron pill replace IV drips before heart surgery?

NCT ID NCT07287371

Disease control Sponsor: University of Rochester 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 compares an oral iron supplement (sucrosomial iron) to the usual intravenous (IV) iron given to anemic patients before heart surgery. About 75 adults with mild anemia scheduled for heart procedures will be randomly assigned to one of the two treatments. The goal is to see if the oral pill is as effective as the IV infusion at raising red blood cell counts before 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 4

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

Participants

About 75 people

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

Expected to start

Dec 2025

An estimate. Start dates often move.

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: * Age ≥18 years * Scheduled for elective cardiac surgical procedures, including: * Coronary artery bypass graft surgery (CABG) * Valve procedures * Aortic root procedures * Transcatheter aortic valve implantation (TAVI) * Hemoglobin \<12 g/dL and ≥10 g/dL on a complete blood count obtained at the Center for Perioperative Medicine pre operative visit * Evidence of iron deficiency * Able to provide informed consent * Able to understand spoken and written English Exclusion Criteria: * Scheduled for cardiac surgery requiring deep hypothermia or circulatory arrest * Undergoing heart transplantation or ventricular assist device placement * Lacking capacity to provide informed consent or unable to understand spoken and written English * Baseline hemoglobin \>12 g/dL or \<10 g/dL * Use of anticoagulant medications within 5 days of the Center for Perioperative Medicine visit, or planned initiation of anticoagulant therapy before surgery * History of hemoglobinopathy * History of hematologic malignancy * Bone marrow suppression from non nutritional causes * Vitamin B12 or folate deficiency * Known liver disease * Known kidney disease * Normal serum iron studies at baseline

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Conditions

The condition(s) this trial relates to.

anemia iron deficiency anemia

As listed by the trial registrant

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

Anemia Iron deficiency anemia

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

  • University of Rochester

    Rochester, New York, 14642, United States

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