Treatment with intravenous iron versus oral iron in anemia by acute gastrointestinal bleeding.

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

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-002660-13-ES

Enrollment

Unknown

Registered

2016-09-30

Start date

2016-11-21

Completion date

Unknown

Last updated

2016-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

FERROPENIC ANAEMIA DUE TO ACUTE GASTROINTESTINAL BLEEDING

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - 18 year old patients admited in a hospital due to an acute gastrointestinal bleeding, which present a Hb=65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

Exclusion criteria: -Associated disease which can influence the evolution of the anaemia (renal chronic failure, liver disease, inflammatory bowel disease, neoplasia, non controlled thyroid disease, malabsorption, folate deficency and/or cianocobalamine deficiency, epo treatement, HIV and hematic disorder). - Gastrointestinal bleeding during the following (the administration of iron supplement). - Need of blood transfusion during the following (during the administration of iron supplement) - Anaemia of a different origin to ferropenia. - Previous chronic anaemia from any origin. - Contraindication to any drug used in the trial.

Design outcomes

Primary

Measure	Time frame
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).;Secondary Objective: Study if the life quality of patiens improves depending on which treatement they have been administrated.;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;Timepoint(s) of evaluation of this end point: Day 0 (at discharge), Days: 7-21-42	—

Measure

Time frame

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).;Secondary Objective: Study if the life quality of patiens improves depending on which treatement they have been administrated.;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;Timepoint(s) of evaluation of this end point: Day 0 (at discharge), Days: 7-21-42

—

Secondary

Measure	Time frame
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)	—

Countries

Spain

Contacts

Public ContactSecretaría de Patología Digestiva

Consorcio Hospital General Universitario de Valencia

luis.ferrer.barcelo@gmail.com0034963131800

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026