One infusion before surgery: could it cut transfusions?
NCT ID NCT05258825
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.
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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 Hide 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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