E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with gastrointestinal bleeding are not candidates for endoscopic treatment with oral anticoagulant previously. |
Los pacientes con hemorragia digestiva no candidatos a tratamiento endoscópico y en tratamiento con anticoagulantes orales previamente. |
|
E.1.1.1 | Medical condition in easily understood language |
Patients treated with oral antociagulantes, have had a gastrointestinal bleeding. |
Los pacientes en tratamiento con antociagulantes orales y que presenten un sangrado digestivo. |
|
E.1.1.2 | Therapeutic area | Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] |
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 |
To assess whether the substitution therapy with vitamin K antagonists by molecular-weight heparin (bemiparin) in patients who have had an episode of gastrointestinal bleeding and who have indications for anticoagulation is associated with a decreased incidence of recurrent gastrointestinal bleeding. |
Evaluar si la sustitución del tratamiento con antagonista de la vitamina K por heparina de bajo peso molecular (bemiparina), en pacientes que hayan presentado un episodio de hemorragia digestiva y que tengan indicación de tratamiento anticoagulante, se asocia a una disminución en la incidencia de recidiva de hemorragia digestiva. |
|
E.2.2 | Secondary objectives of the trial |
- Incidencia de episodios tromboembólicos - Hemorragias en otras localizaciones - Severidad de los episodios de recurrencia hemorrágica - Necesidades transfusionales - Identificación de factores de riesgo asociados - Mortalidad |
- Incidence of thromboembolic episodes - Bleeding from other locations - Severity of episodes of recurrent bleeding - Need for transfusion - Identification of risk factors associated - mortality |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients with anticoagulant therapy criteria (acenocoumarol or warfarin-treated) and high or very high risk embolism, which have had an acute gastrointestinal bleeding (low or high) not amenable to endoscopic treatment, vascular lesions secondary to multiple diverticular origin, or with not clear origen (after gastroscopy and colonoscopy) that have no exclusion criteria. |
Pacientes con criterios de tratamiento anticoagulante (tratados con acenocumarol o warfarina) y con alto o muy alto riesgo embolígeno, que presentan una hemorragia digestiva aguda (alta o baja) no susceptible a tratamiento endoscópico, secundaria a lesiones vasculares múltiples, de origen diverticular, o bien de origen no aclarado (tras realización de una gastroscopia y una colonoscopia) que no tengan ningún criterio de exclusión. |
|
E.4 | Principal exclusion criteria |
A) under 18 years. B) pregnancy. C) patient refusal to participate in the study. D) patients who took the decision not to provide active treatment for the existence of any clinical condition considered terminal (severe associated diseases evolved). E) LMWH contraindication (allergy, heparin-induced thrombocytopenia). F) bleeding secondary to esophageal varices and / or gastric ulcers. G) bleeding associated with peptic injury. H) bleeding secondary to tumors or polyps. i) Presence of portal hypertension with or without liver cirrhosis. J) bleeding due to Mallory-Weiss syndrome. K) anticoagulation low risk for injury embolism. |
A) edad inferior a 18 años. B) embarazo. C) negativa del paciente para participar en el estudio. D) pacientes en los que se haya adoptado la decisión de no proporcionar ningún tratamiento activo por la existencia de alguna situación clínica considerada terminal (enfermedades asociadas graves evolucionadas). E) Contraindicación HBPM (alergia, trombocitopenia inducida por heparina). F) Hemorragias secundarias a varices esofágicas y/o gástricas. G) Hemorragias asociadas a lesiones pépticas. H) Hemorragias secundarias a neoplasias o pólipos. i) Presencia de hipertensión portal con o sin cirrosis hepática. J) Hemorragias debidas a síndrome de Mallory-Weiss. K) Descoagulación por lesiones de bajo riesgo embolígeno. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Digestive bleeding incidence |
Incidencia hemorragia digestiva. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
- Mortality - Severity of the recurrence - Incidence tromboembolism - Asotiation with AINEs, aspirin AAs or other antiagregants. - Complications of treatment |
- Mortalidad - Gravedad de la recidiva - Incidencia de episodios tromboembólicos - Asociación con AINEs, aspirina AAs u otros antiagregantes. - Complicaciones del tratamiento |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
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 | Yes |
E.8.2.3.1 | Comparator description |
bemiparina vs warfarina |
bemiparina vs warfarina |
|
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 | Information not present in EudraCT |
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
|
When it is required by the patient or by investigator decision. |
Cuando sea requerido por el paciente o cuando sea decisión del investigador. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |