Treatment of Ferropenic Anaemia due to acute gastrointestinal bleeding: oral vs intravenous iron therapy

INTERVENTION: Trade Name: Ferinject 50 mg/ml Solución inyectable y para perfusión Pharmaceutical Form: Solution for injection/infusion INN or Proposed INN: FERRIC CARBOXYMALTOSE CAS Number: 9007‐72‐1 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 50‐ Trade Name: Ferogradumet 105 mg comprimidos de liberación prolongada Pharmaceutical Form: Prolonged‐release tablet INN or Proposed INN: IRON SULFATE CAS Number: 7720‐78‐7 Other descriptive name: FERROUS SULFATE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 525‐ CONDITION: FERROPENIC ANAEMIA DUE TO ACUTE GASTROINTESTINAL BLEEDING Therapeutic area: Diseases [C] ‐ Blood and lymphatic diseases [C15] PRIMARY OUTCOME: Main Objective: Study the evolution of the ferropenic anaemia due to an acute gatrointestinal bleeding not secundary to portal hypertension comparing two different ways of iron supplement administration (Oral vs Intravenous). Primary end point(s): ‐ Evolution of hemoglobin levels.; ‐ Evolution of iron levels (TSI, Fe, Ferritin); ‐ Quality of life (EuroQoL‐5, SF36); ‐ Adherence to the treatment; ‐ Adverse effects Secondary Objective: Study if the life quality of patiens improves depending on which treatement they have been administrated. Timepoint(s) of evaluation of this end point: Day 0 (at discharge), Days: 7‐21‐42 SECONDARY OUTCOME: Secondary end point(s): ‐ Gastrointestinal bleeding ethiology; ‐ Presence of anticoagulation/antiagregation/proton bomb inhibitors; ‐ Number of transfunded patients; ‐ Number of hemoderivated units transfused Timepoint(s) of evaluation of this end point: Day 0 (discharged) INCLUSION CRITERIA: ‐ 18 year old patients admited in a hospital due to an acute gastrointestinal bleeding, which present a Hb<10 g/dl, once the bleeding has stopped and the patient is stable. ‐ Consent form signed. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 70 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30