NCT05304442

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

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Baylor College of Medicine · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 safety and superiority to oral iron therapy in other acute care settings. Furthermore, red blood cell (RBC) transfusions may be over-utilized in hemodynamically stable patients with IDA, potentially increasing risk for transfusion reactions, infection, and allo-antibody formation among other adverse outcomes. Improved treatment of iron deficiency may reduce the need for subsequent RBC transfusions. Compared with oral iron, treatment with intravenous iron may result in improved adherence, fewer health care visits, more rapid correction of IDA, and overall improvement in quality of life. Historically, older formulations of IV Iron, namely high-molecular weight iron dextran (HMWID), were associated with unacceptably high rates of severe allergic reactions and/or required multiple doses to replete iron stores. However, newer formulations of IV iron are not only extremely safe, but can also be administered as a single "total dose infusion" over a very short time period. These newer forms of IV iron include ferric carboxymaltose, low-molecular weight iron dextran, ferumoxytol, and ferric derisomaltose. When excluding HMWID, a meta-analysis of 97 RCTs found that there was no increase in the risk of serious adverse events (SAE's) with IV iron compared with control and no increased risk of systemic infection. A large retrospective, "before and after" study conducted in an Italian Emergency Department demonstrated that implementation of Patient Blood Management protocols, including the use of IV iron in the emergency department, resulted in a substantial reduction in red blood cell transfusions, hospitalization, re-transfusion, length of stay and costs. Similar conclusions were reached in smaller studies by Motta et al and Khadadah et al. The investigators recently published a retrospective cohort study examining current emergency department practices in the evaluation and management of IDA in the target population for the proposed trial. The results of this cohort study revealed that women with AUB and severe anemia are frequently seen in the Ben Taub Emergency Department, that red blood cell transfusions are commonly administered, and that IV iron is infrequently (or never) used in the ED setting. Furthermore, unplanned return visits and recurrent transfusions were common.

Conditions

• Anemia, Iron Deficiency
• Uterine Bleeding

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-09-15
• Primary completion: 2025-03-01
• Completion: 2025-04-01
• First posted: 2022-03-31
• Last updated: 2024-12-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study