Iron Supplementation in Upper Non-variceal Gastrointestinal Bleeding
NCT05060731 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 570
Last updated 2025-03-30
Summary
Anemia is a frequent complication of gastrointestinal bleeding, affecting 61% of the patients. Currently, anemia caused by gastrointestinal bleeding can be treated with iron supplementation. However, the dose and route of the administration are still a question. The FIERCE clinical trial aims to compare the effect of intravenous iron supplementation and oral iron replacement on mortality, unplanned emergency visits, and hospital readmissions in multimorbid patients with acute nonvariceal gastrointestinal bleeding.
Conditions
- GastroIntestinal Bleeding
- Anemia
Interventions
- DRUG
-
Oral iron supplementation
Ca. 200-300 mg of ferrous sulfate will be administered orally every day for 3 months.
- DRUG
-
Intravenous iron supplementation
One dose of intravenous 1000 mg ferric carboxymaltose will be administered on the day of randomization.
Sponsors & Collaborators
-
University of Pecs
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-09-01
- Primary Completion
- 2027-12-31
- Completion
- 2028-02-01
Countries
- Hungary
Study Locations
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