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

Launched by BAYLOR COLLEGE OF MEDICINE · Mar 22, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating how well a new intravenous (IV) iron treatment called Ferric Derisomaltose works compared to taking iron by mouth for women who have severe anemia caused by uterine bleeding. Anemia means your body doesn’t have enough healthy red blood cells, which can make you feel tired and weak. The trial is taking place in the emergency department and aims to find out which treatment is more effective for helping women recover from this condition.

To participate in the trial, women need to be between the ages of 18 and 80, have moderate to severe anemia (with a specific blood measurement), and have low iron levels. They should also be able to follow up for visits in three and six weeks after treatment and be willing to provide consent to join the study. Participants can expect to receive either the IV iron treatment or oral iron and will be monitored closely for their recovery. It’s important to know that some people, including those who are pregnant or have certain health conditions, may not be eligible to join the trial.

Gender

FEMALE

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