Intravenous Ferric Derisomaltose for Moderate to Severe Anemia Due to Uterine Bleeding in the Emergency Department: a Randomized Trial
Baylor College of Medicine
Summary
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.
Description
Iron deficiency anemia (IDA) is the most common hematologic disorder in the United States and worldwide. Patients with moderate to severe anemia often present to the acute care setting for initial assessment and evaluation; women with abnormal uterine bleeding are among those at highest risk. Guidelines on management of this common condition in the emergency department (ED) are lacking. Although IDA is commonly encountered in the ED, there is a paucity of literature addressing optimal management in this setting. Intravenous (IV) iron therapy is infrequently used in the ED despite evidence of…
Eligibility
- Age range
- 18–65 years
- Sex
- Female
- Healthy volunteers
- No
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 hypersensi…
Interventions
- DrugFerric Derisomaltose 1000 Mg in 10 mL INTRAVENOUS SOLUTION [Monoferric]
Single Dose of IV Iron
- DrugFerrous Sulfate 65 mg elemental iron (325 mg tablets)
Once daily by mouth for 42 days
Location
- Ben Taub HospitalHouston, Texas