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Intravenous ferric carboxymaltose versus oral ferrous sulfate replacement in elderly patients after acute non-variceal gastrointestinal bleeding (FIERCE): protocol of a multicentre, open-label, randomised controlled trial

Centre for Translational Medicine, Semmelweis University, Budapest, Hungary. Institute for Translational Medicine, Medical School, University of Pécs, Pécs, Hungary. Institute of Pancreatic Diseases, Semmelweis University, Budapest, Hungary. Institute of Bioanalysis, Medical School, University of Pécs, Pécs, Baranya, Hungary. Fejér County Szent György, University Teaching Hospital, Székesfehérvár, Hungary. Division of Gastroenterology, First Department of Medicine, Medical School, University of Pécs, Pécs, Hungary. Division of Hematology, First Department of Medicine, Medical School, University of Pécs, Pécs, Hungary. Centre for Translational Medicine, Semmelweis University, Budapest, Hungary eross.balint@pte.hu.

BMJ open. 2023;13(3):e063554
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Abstract
INTRODUCTION 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. METHODS AND ANALYSIS 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. ETHICS AND DISSEMINATION 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. TRIAL REGISTRATION The trial has been registered at ClinicalTrials.gov (NCT05060731).
Study details
Language : eng
Credits : Bibliographic data from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine