(TKP2021-EGA-23) Funder: Ministry for Innovation and Technology
Acute gastrointestinal bleeding (GIB) is a life-threatening emergency with a critical
economic burden. As a result of bleeding, anaemia often requires intravenous or oral
iron supplementation. Elderly patients are even more prone to untoward outcomes after
hospital discharge if iron supplementation is inefficient. There is a gap in current
guidelines on which supplementation route clinicians should choose. We aim to investigate
the effect of one dose of intravenous iron therapy versus 3-month oral iron administration
on anaemia in an elderly population.The FIERCE study is an open-label, randomised
controlled, two-armed trial. At least 48 hours after the acute non-variceal GIB treatment,
patients will be recruited in participating centres. A random sequence generator will
allocate the participants to group A (intravenous ferric carboxymaltose, 1000 mg)
or group B (oral ferrous sulfate (FS), ca. 200 mg every day) with an allocation ratio
of 1:1 on the day of the planned discharge from the hospital. Randomisation will be
stratified for participating centres and the need for transfusion within the same
hospitalisation before recruitment to the trial. Quality of life assessment, functional
measurement and laboratory tests will be performed at baseline, 1 and 3 months±7 days
after enrolment to the trial. The primary endpoint is a composite endpoint, including
all-cause mortality, anaemia-associated unplanned emergency visit and anaemia-associated
unplanned hospital admission within 3 months of enrolment in the trial.The study has
been approved by the relevant organisation, the Scientific and Research Ethics Committee
of the Hungarian Medical Research Council (46395-5/2021/EÜIG). We will disseminate
our results to the medical community and will publish our results in peer-reviewed
journals.The trial has been registered at ClinicalTrials.gov (NCT05060731).
