Phase
Condition
Gastric Ulcers
Gastrointestinal Diseases And Disorders
Ulcers
Treatment
Intravenous iron supplementation
Oral iron supplementation
Clinical Study ID
Ages > 65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
age ≥ 65 years;
endoscopically proven acute nonvariceal GIB source;
48 hours after the endoscopic diagnosis and/or treatment;
hemodynamically stable;
the discharge of the patient is planned;
hemoglobin level <10 g/dl on the day of randomisation;
24 hours after the last transfusion and no need for further transfusion;
signed informed consent.
Exclusion
Exclusion Criteria:
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 ofiron utilisation;
pregnancy or breast feeding;
diagnosis of iron malabsorption (at discretion of the attending clinician; e.g.,severe inflammatory bowel disease, active celiac disease);
chronic end stage diseases (chronic heart failure-New York Heart AssociationClassification class 4, chronic kidney disease (eGFR <30 mL/min/1.73 m2) with orwithout dialysis, liver cirrhosis with Child Pugh C score, chronic kidney diseasewith dialysis, chronic obstructive pulmonary disease stage 4, chronic inflammatorydisease, malignancies, AIDS);
active malignancies;
liver cirrhosis with known varices at high risk of bleeding - endoscopic features ofhigh risk of variceal bleeding or liver stiffness measured by transient elastography >20 kiloPascal and platelet count <150 × 10^9 cells/L;
gastrointestinal tract malignancies with high risk of gastrointestinal bleeding;
high risk of poor compliance or no fixed abode;
myelo- or lymphoproliferative diseases;
anemia not attributable to iron deficiency (sideroblastic anaemia, aplastic anaemia,haemolytic anaemia, thalassaemia, B12 vitamin or folic acid deficiency orcombination of these with IDA);
primary coagulation disorders (e.g. Glanzmann thrombasthenia, Von Willebranddisease, Haemophylia A, Haemophylia B);
the patient will be transferred to another institute after discharge (e.g. hospital,senior care center);
Eastern Cooperative Oncology Group (ECOG) Performance Status >2.
Study Design
Study Description
Connect with a study center
Institute for Translational Medicine, University of Pécs
Pécs, 7624
HungarySite Not Available

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