[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100443924":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":28,"locations":38,"responsibleParty":51,"collaborators":24,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":57,"sex":63,"minAge":64,"maxAge":24,"enrollmentInfo":65,"targetDuration":24,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":75,"overallStatus":79,"whyStopped":24,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"University of Pecs","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Oral iron supplementation","ACTIVE_COMPARATOR","Patients randomized to receive oral ferrous sulfate, ca. 200-300 mg every day for 3 months.",[13],"Drug: Oral iron supplementation",{"label":15,"type":10,"description":16,"interventionNames":17},"Intravenous iron supplementation","Patients randomized to receive one dose of 1000 mg intravenous ferric carboxymaltose.",[18],"Drug: Intravenous iron supplementation",[20,25],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","Ca. 200-300 mg of ferrous sulfate will be administered orally every day for 3 months.",[9],null,{"type":21,"name":15,"description":26,"armGroupLabels":27,"otherNames":24},"One dose of intravenous 1000 mg ferric carboxymaltose will be administered on the day of randomization.",[15],[29,34],{"name":30,"role":31,"phone":32,"phoneExt":24,"email":33},"Bálint Erőss, MD, PhD","CONTACT","+3630\u002F887-4028","eross.balint@pte.hu",{"name":35,"role":31,"phone":36,"phoneExt":24,"email":37},"Péter Hegyi, MD, PhD, DSc, MAE","+3670\u002F375-1031","p.hegyi@tm-centre.org",[39],{"facility":40,"status":24,"city":41,"state":24,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":24},"Institute for Translational Medicine, University of Pécs","Pécs","7624","Hungary","HU",{"type":46,"coordinates":47},"Point",[48,49],18.22814,46.07617,{"lat":49,"lon":48},{"type":52,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"PRINCIPAL_INVESTIGATOR","dr Erőss Bálint","Principal Investigator, Director of the Centre for Translational Medicine at University of Pécs","100443924","phase-4-iron-supplementation-in-upper-non-variceal-gastrointestinal-bleeding-100443924",false,"NCT05060731","Iron Supplementation in Upper Non-variceal Gastrointestinal Bleeding","Intravenous Ferric Carboxymaltose Versus Oral Ferrous Sulfate Replacement in Anaemia Due to Acute Nonvariceal Gastrointestinal Bleeding (FIERCE): Protocol of a Multicentre Randomised Controlled Trial","FIERCE","Inclusion Criteria:\n\n1. age ≥ 65 years;\n2. endoscopically proven acute nonvariceal GIB source;\n3. 48 hours after the endoscopic diagnosis and\u002For treatment;\n4. hemodynamically stable;\n5. the discharge of the patient is planned;\n6. hemoglobin level \\\u003C10 g\u002Fdl on the day of randomisation;\n7. 24 hours after the last transfusion and no need for further transfusion;\n8. signed informed consent.\n\nExclusion Criteria:\n\n1. known hypersensitivity to iron products (mild side effects excluded);\n2. previous diagnosis of iron overload \\[e.g., transferrin receptor saturation (TSAT) \\>50%, ferritin\\> 160 for women ng\u002Fml, ferritin \\>270 ng\u002Fml for men) or disorders of iron utilisation;\n3. pregnancy or breast feeding;\n4. diagnosis of iron malabsorption (at discretion of the attending clinician; e.g., severe inflammatory bowel disease, active celiac disease);\n5. chronic end stage diseases (chronic heart failure-New York Heart Association Classification class 4, chronic kidney disease (eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m2) with or without dialysis, liver cirrhosis with Child Pugh C score, chronic kidney disease with dialysis, chronic obstructive pulmonary disease stage 4, chronic inflammatory disease, malignancies, AIDS);\n6. active malignancies;\n7. liver cirrhosis with known varices at high risk of bleeding - endoscopic features of high risk of variceal bleeding or liver stiffness measured by transient elastography \\>20 kiloPascal and platelet count \\\u003C150 × 10\\^9 cells\u002FL;\n8. gastrointestinal tract malignancies with high risk of gastrointestinal bleeding;\n9. high risk of poor compliance or no fixed abode;\n10. myelo- or lymphoproliferative diseases;\n11. anemia not attributable to iron deficiency (sideroblastic anaemia, aplastic anaemia, haemolytic anaemia, thalassaemia, B12 vitamin or folic acid deficiency or combination of these with IDA);\n12. primary coagulation disorders (e.g. Glanzmann thrombasthenia, Von Willebrand disease, Haemophylia A, Haemophylia B);\n13. the patient will be transferred to another institute after discharge (e.g. hospital, senior care center);\n14. Eastern Cooperative Oncology Group (ECOG) Performance Status \\>2.","ALL","65 Years",{"count":66,"type":67},570,"ESTIMATED","INTERVENTIONAL",[70],"PHASE4","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.",[73,74],"GastroIntestinal Bleeding","Anemia",[76,77,78],"non-variceal upper gastrointersinal bleeding","iron supplementation","intravenous iron","NOT_YET_RECRUITING","2025-03-25",{"date":82,"type":83},"2025-03-30","ACTUAL",{"date":85,"type":67},"2025-09-01",{"date":87,"type":67},"2028-02-01",{"name":5,"class":6},1]