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

Recruiting now · Phase 3

Conditions studied: Anemia, Iron Deficiency, Uterine Bleeding

In brief

The primary aim of this randomized trial is to assess the efficacy of IV Ferric Derisomaltose vs Oral Iron in the management of women with severe Iron Deficiency Anemia due to Uterine Bleeding in the emergency department.

Key facts

Study ID

NCT05304442

Run by

Baylor College of Medicine

People needed

40

Starts

2022-09-15

Expected to finish

2025-04-01

Last updated by the study team

2024-12-05

Who can join

Age: 18 and older, up to 65. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

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

Full record on ClinicalTrials.gov

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