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RECRUITING

NCT05304442

PHASE3

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

Sponsor: Baylor College of Medicine

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2022-09-15

Completion Date

2025-04

Last Updated

2024-12-05

Healthy Volunteers

Conditions

Anemia, Iron Deficiency Uterine Bleeding

Interventions

DRUG

Ferric Derisomaltose 1000 Mg in 10 mL INTRAVENOUS SOLUTION [Monoferric]

Single Dose of IV Iron

DRUG

Ferrous Sulfate 65 mg elemental iron (325 mg tablets)

Once daily by mouth for 42 days

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

Locations (1)

Ben Taub Hospital

Houston, Texas, United States