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

What this Trial Is About

This research aims to evaluate the effectiveness of intravenous (IV) Ferric Derisomaltose compared to oral iron in treating women with severe iron deficiency anemia caused by uterine bleeding who present to the emergency department. Iron deficiency anemia is a common blood disorder, especially among women with abnormal uterine bleeding, and there is limited guidance on managing this condition in emergency settings. The study addresses concerns about overuse of blood transfusions and investigates newer IV iron formulations that may be safer and more effective than traditional oral treatments. Participants will be randomly assigned to receive either a single intravenous dose of 1000 mg Ferric Derisomaltose administered over at least 20 minutes or oral ferrous sulfate 65 mg once daily for 42 days. The study includes a phase for initial treatment followed by assessments at 3 and 6 weeks to evaluate changes in hemoglobin levels. This design allows comparison of the two iron therapies in the acute care context of the emergency department. During the study, women will attend follow-up visits at 3 and 6 weeks where their hemoglobin concentration will be measured to assess treatment response. Researchers will monitor adherence, safety, and quality of life, focusing on the mean change in hemoglobin as the primary outcome at 3 weeks, with additional evaluation at 6 weeks. Participants must be reachable by phone and able to attend these visits, with the total study duration spanning at least 6 weeks after enrollment.

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