Actively Recruiting
IV Iron Trial for Anemia Related to Uterine Bleeding in Female Patients Presenting to the Emergency Department
Led by Baylor College of Medicine · Updated on 2024-12-05
40
Participants Needed
1
Research Sites
132 weeks
Total Duration
On this page
Sponsors
B
Baylor College of Medicine
Lead Sponsor
P
Pharmacosmos Therapeutics, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
IV Iron Trial for Anemia Related to Uterine Bleeding in Female Patients Presenting to the Emergency Department
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Sub-acute or chronic uterine blood loss
- Moderate to severe anemia with hemoglobin less than or equal to 9.0 g/dL
- Iron deficiency with serum ferritin less than or equal to 30 ng/mL
- Eligible for discharge from the emergency department after treatment
- Able to return for follow-up visits at 3 and 6 weeks
- Able to be reached by telephone
- Willing and able to provide consent for participation
You will not qualify if you...
- Requires hospitalization for any reason
- Pregnant or nursing
- Incarcerated or prisoner
- Weighs less than 50 kg
- History of hypersensitivity to any parenteral iron formulation
- History of anaphylactic allergy
- Received intravenous iron or erythropoiesis-stimulating agents recently
- Received erythropoiesis-stimulating agents within 8 weeks prior to emergency department visit
- Received parenteral iron within 4 weeks prior to emergency department visit
- Scheduled to receive parenteral iron or erythropoiesis-stimulating agents during the study
- Received blood transfusion at the initial visit
- Planned major surgery during the study period
- Current or recent hematologic therapy as specified
- Current or planned use of antithrombotic therapy (antiplatelet or anticoagulants) during the study period (non-aspirin NSAIDs allowed)
- Known bleeding disorder with platelets less than 100,000
- Active rheumatologic disease requiring treatment
- Acute or chronic heart failure (NYHA II-IV)
- Inflammatory bowel disease
- Cirrhosis or decompensated liver disease
- Chronic kidney disease stage III or greater (eGFR < 60)
- Current systemic infection except cystitis or cervicitis
- Any other medical or surgical condition making participation unsuitable as judged by the physician
AI-Screening
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Trial Site Locations
Total: 1 location
1
Ben Taub Hospital
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
S
Stephen Boone, MD
CONTACT
K
Kelly R Keene, BSN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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