Iron Supplementation in Upper Non-variceal Gastrointestinal Bleeding
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age65+
SponsorUniversity of Pecs
About this trial
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.
Eligibility criteria
Qualifiers
age ≥ 65 years;
endoscopically proven acute nonvariceal GIB source;
48 hours after the endoscopic diagnosis and/or treatment;
hemodynamically stable;
Disqualifiers
known hypersensitivity to iron products (mild side effects excluded);
previous diagnosis of iron overload [e.g., transferrin receptor saturation (TSAT) >50%, ferritin> 160 for women ng/ml, ferritin >270 ng/ml for men) or disorders of iron utilisation;
pregnancy or breast feeding;
diagnosis of iron malabsorption (at discretion of the attending clinician; e.g., severe inflammatory bowel disease, active celiac disease);
Trial design
Treatments tested in this trial
- Oral iron supplementation
- Intravenous iron supplementation
Treatment groups
570 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov