One infusion before surgery: could it cut transfusions?

NCT ID NCT05258825

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 26, 2026 · Last updated Aug 27, 2026 · Updated 1 time

Summary

This trial tests whether a single intravenous dose of iron, given 3-4 weeks before elective abdominal or pelvic surgery, can raise hemoglobin levels in patients with iron-deficiency anemia. The goal is to see if this simple pre-op step reduces the need for blood transfusions, lowers complications, and shortens hospital stays. Adults with low hemoglobin and iron stores who are scheduled for such surgery may participate. The study also explores how practical it is to set up this infusion program in a US hospital.

What this could mean

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

Active substance
Monoferric (intravenous iron)
What this could lead to
If it works, a single pre-surgery iron infusion could become a standard way to boost hemoglobin, reduce blood transfusions, and shorten hospital stays for anemic patients facing abdominal surgery.
What could go wrong
This is a small, early-stage feasibility study, so results may not apply broadly. Risks include allergic reactions to IV iron and the possibility that one dose may not raise hemoglobin enough to change outcomes.

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

37 people

The number who actually took part.

Started

Apr 2023

Finished

Jun 2025

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: * Men or women ≥18 years old * Hemoglobin ≤12 g/dL, and ferritin \<30ng/mL or transferrin \<20% * Scheduled to undergo elective abdominal/pelvic surgery * Willingness to participate and sign the informed consent form Exclusion Criteria: * Non-iron deficiency anemia * Hemochromatosis or other iron storage disorders * Previous serious hypersensitivity reactions to any IV iron compounds * Treated with intravenous iron within 10 days of IV iron intervention * Patient has or will be treated with a red blood cell transfusion within 30 days of scheduled surgery * Received another investigational drug within 30 days of scheduled surgery * Requiring dialysis or being considered for dialysis * Already on erythropoietin stimulating agents * Evidence of decompensated liver cirrhosis or active hepatitis * Active infection, sepsis * Alcohol or drug abuse within the past 6 months * Estimated life expectancy of \< 1 year * Pregnant or nursing women * Expecting excessive surgical bleeding

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

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