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

Ki vehet részt

• 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

Ki nem vehet részt

• Erythropoiesis-stimulating agent use within 8 weeks prior to ED visit
• Parenteral iron within 4 weeks prior to ED 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)
• History of hypersensitivity reactions, as specified, known hypersensitivity to any formulation of parenteral iron
• History of any anaphylactic allergy
• 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
• 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
• Known bleeding disorder platelets < 100,000'
• Chronic kidney disease, stage III or greater (eGFR < 60)
• Patient requiring hospitalization for any reason
• Pregnant or nursing
• Incarcerated/Prisoner
• Weight < 50 kg
• Recent receipt of IV iron, erythropoiesis-stimulating agents
• Scheduled/planned use of parenteral iron or ESA during study period
• Receipt of blood transfusion at index visit
• Other significant underlying comorbidity, as specified: