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IV Iron for Anemia from Uterine Bleeding in the Emergency Department

This study is looking at the best way to treat women who come to the emergency department with severe anemia (low red blood cell count) caused by uterine bleeding. Researchers want to compare a single dose of intravenous (IV) Ferric Derisomaltose (Monoferric) to taking oral Ferrous Sulfate tablets daily for 42 days. To join, you must be a woman between 18 and 65 years old, have moderate to severe anemia (hemoglobin 9.0 g/dl or less), and iron deficiency (serum ferritin 30 ng/mL or less) due to uterine bleeding. The main goal is to see how much your hemoglobin level changes after 3 weeks. The study is currently recruiting about 40 participants, but its status is unclear.

Study design
This is a randomized study comparing two treatments, with about 40 participants planned. The phase of the study is not specified.
What's involved
You would need to return for follow-up visits at 3 and 6 weeks after treatment. You also need to be reachable by telephone.
Compensation
Not stated in the trial record.
Follow-up
Participants are followed for at least 6 weeks after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05304442

IV Iron Trial for Anemia Related to Uterine Bleeding in Female Patients Presenting to the Emergency Department

Recruiting
PHASE3Ages 18–65InterventionalTreatment
Baylor College of Medicine
~40 participants
Updated 2024-12-05 on ClinicalTrials.gov
What's tested:Ferric Derisomaltose 1000 Mg in 10 mL INTRAVENOUS SOLUTION [Monoferric]Ferrous Sulfate 65 mg elemental iron (325 mg tablets)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
mean change in hemoglobin concentration
Measured over 3 weeks

Conditions

Anemia, Iron Deficiency
Uterine Bleeding

Explore related trials

Iron-Deficiency AnemiaUterine HemorrhageFerritin

NCT05304442

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Ben Taub Hospital

    Houston, Texasstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Stephen Boone, MD
[email protected]
8324099126
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

Sub-acute or chronic uterine blood loss;
Moderate to Severe Anemia, defined as Hgb less than or equal to 9.0 g/dl;
Iron deficiency: Serum ferritin less than or equal to 30 ng/mL;
Eligible for discharge from the ED following treatment;
Patient able to return for planned follow-up visits at 3 and 6 weeks;
Patient able to be reached by telephone;
Willing and able to provide consent for participation.

Exclusion

Patient requiring hospitalization for any reason;
Pregnant or nursing;
Incarcerated/Prisoner;
Weight \< 50 kg;
History of hypersensitivity reactions, as specified, known hypersensitivity to any formulation of parenteral iron;
History of any anaphylactic allergy;
Recent receipt of IV iron, erythropoiesis-stimulating agents;
Erythropoiesis-stimulating agent use within 8 weeks prior to ED visit;
Parenteral iron within 4 weeks prior to ED visit;
Scheduled/planned use of parenteral iron or ESA during study period;
Receipt of blood transfusion at index visit;
Planned elective major surgery during study period;
Other current or recent hematologic therapy, as specified;
Current or planned use of antithrombotic therapy (antiplatelet agents or anticoagulants) within study period (Non-aspirin NSAIDs are NOT a contraindication);
Known bleeding disorder platelets \< 100,000';
Other significant underlying comorbidity, as specified:
Active rheumatologic disease, or rheumatologist disease requiring treatment, such as rheumatoid arthritis, systemic lupus erythematosus, or mixed connective tissue disease;
Acute heart failure or NYHA II-IV chronic heart failure;
Inflammatory bowel disease;
Cirrhosis or Decompensated liver disease;
Chronic kidney disease, stage III or greater (eGFR \< 60);
Current Systemic Infection (e.g. pneumonia, pelvic inflammatory disease, pyelonephritis). \*Cystitis or cervicitis is NOT an exclusion
Any other medical or surgical condition that in the opinion of the treating physician may result in patient being unsuitable for trial participation

What this trial measures

  • mean change in hemoglobin concentration3 weeks

    participants will have increased hemoglobin concentrations