Intravenous Ferric Derisomaltose for Moderate to Severe Anemia Due to Uterine Bleeding in the Emergency Department: a Randomized Trial
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• 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.
Locations
United States
Texas
Ben Taub Hospital
RECRUITING
Houston
Contact Information
Primary
Stephen Boone, MD
Stephen.Boone@bcm.edu
8324099126
Backup
Kelly R Keene, BSN
kelly.keene@bcm.edu
8323682476
Time Frame
Start Date: 2022-09-15
Estimated Completion Date: 2025-04
Participants
Target number of participants: 40
Treatments
Experimental: Intravenous Ferric Derisomaltose
One single dose of ferric derisomaltose, 1000 mg Intravenous over at least 20 minutes.
Active_comparator: Oral Iron
ferrous sulfate 65 mg once daily for 42 days.
Related Therapeutic Areas
Sponsors
Leads: Baylor College of Medicine
Collaborators: Pharmacosmos Therapeutics, Inc.