IV Iron treatment for anemia in women with uterine bleeding

Intravenous Ferric Derisomaltose for Moderate to Severe Anemia Due to Uterine Bleeding in the Emergency Department: a Randomized Trial

This study is testing whether an IV iron treatment works better than oral iron for women with severe anemia caused by heavy bleeding.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 65 Years
• Sex: Female
• Sponsor: Baylor College of Medicine (Academic / other)
• Locations: 1 site (Houston, Texas)
• Trial ID: NCT05304442 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are women with moderate to severe anemia due to sub-acute or chronic uterine blood loss who are eligible for discharge from the emergency department.

Not a fit: Patients requiring hospitalization, pregnant or nursing women, and those with a history of severe allergic reactions to iron formulations will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could lead to faster recovery from anemia and improved quality of life for women experiencing uterine bleeding.

How similar studies have performed: Other studies have shown that intravenous iron therapy can be more effective than oral iron in acute settings, indicating a promising approach for this trial.

Eligibility criteria

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 this trial is running

Houston, Texas

• Ben Taub Hospital — Houston, Texas, United States (Recruiting)

Study contacts

• Study coordinator: Stephen Boone, MD

Conditions Anemia, Iron Deficiency; Uterine Bleeding; IV Iron; Emergency Department; Iron Deficiency Anemia