IV Iron treatment for anemia in women with uterine bleeding

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized trial aims to evaluate the effectiveness of intravenous Ferric Derisomaltose compared to oral iron in treating women with severe iron deficiency anemia caused by uterine bleeding in the emergency department. The study addresses a significant gap in the management of iron deficiency anemia, particularly in acute care settings, where current guidelines are lacking. By focusing on a population at high risk for anemia, the trial seeks to improve treatment outcomes and reduce the need for red blood cell transfusions. Participants will receive either IV iron or oral iron and will be monitored for efficacy and safety.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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

Where it's running

• Ben Taub Hospital
  Houston, Texas, United States Recruiting

Study contacts

• Study coordinator: Stephen Boone, MD
• Email: Stephen.Boone@bcm.edu
• Phone: 8324099126

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.