E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
FERROPENIC ANAEMIA DUE TO ACUTE GASTROINTESTINAL BLEEDING |
ANEMIA FERROPÉNICA SECUNDARIA A HEMORRAGIA DIGESTIVA AGUDA |
|
E.1.1.1 | Medical condition in easily understood language |
FERROPENIC ANAEMIA AFTER A GASTROINTESTINAL BLEEDING |
ANEMIA FERROPÉNICA TRAS HEMORRAGIA DIGESTIVA AGUDA |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Blood and lymphatic diseases [C15] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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). |
Estudiar la evolución de la anemia ferropénica posthemorragia digestiva aguda no secundaria a hipertensión portal, comparando dos pautas de tratamiento con Fe: oral e infusión endovenosa. |
|
E.2.2 | Secondary objectives of the trial |
Study if the life quality of patiens improves depending on which treatement they have been administrated. |
Estudiar si la calidad de vida de los pacientes mejora en función del tratamiento administrado. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
• Pacientes mayores de 18 años ingresados en un hospital de 3er nivel por hemorragia digestiva aguda, tanto alta como baja y que presentan al alta hospitalaria una Hb < 10 g/dl, estando cedida la hemorragia digestiva y el paciente en estabilidad clínica. • Firma de consentimiento informado. |
|
E.4 | Principal 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. |
• Patología asociada que puede influir en la evolución de la anemia (insuficiencia renal crónica, hepatopatía, enfermedad inflamatoria crónica, neoplasias, alteraciones tiroideas no compensadas, malabsorción, déficit de ácido fólico y/o vitamina B12, tratamiento con eritropoyetina, VIH, trastornos hematológicos). • Recidiva hemorrágica entre el día 0 y el día 42. • Requerimiento transfusional en el periodo comprendido entre el día 0 y el día 42. • Anemias de origen mixto (no ferropénica pura). • Anemias crónicas previas de cualquier origen. • Contraindicación a la toma de alguno de los fármacos empleados en el estudio. |
|
E.5 End points |
E.5.1 | 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 |
• Evolución de las cifras de Hb (días 0, 7, 21, 42) • Evolución de las cifras de parámetros del Fe (días 0, 7, 21, 42) • Calidad de vida (EuroQoL-5, SF 36) • Adherencia al tratamiento • Efectos adversos |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Day 0 (at discharge), Days: 7-21-42 |
Día 0 (al alta hospitalaría), días: 7- 21 - 42 |
|
E.5.2 | Secondary end point(s) |
- Gastrointestinal bleeding ethiology - Presence of anticoagulation/antiagregation/proton bomb inhibitors - Number of transfunded patients - Number of hemoderivated units transfused |
• Diagnóstico de origen de la hemorragia digestiva • Presencia de anticoagulación/antiagregación/IBP • Número de pacientes transfundidos • Unioades de concentrado de hematíes transfundidas |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Day 0 (discharged) |
Día 0 (al alta hospitalaria) |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
LVLS (day 42) |
Última visita del ensayo (día 42) |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |