Study comparing two anticoagulation drucgs, bemiparin and warfarin, in patients who have had gastrointestinal bleeding and need for his illness to be anticoagulated

Phase 1

Conditions: Patients with gastrointestinal bleeding are not candidates for endoscopic treatment with oral anticoagulant previously.
Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

Registration Number: EUCTR2008-006887-12-ES

Lead Sponsor: Institut de Recerca HSCSP

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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.
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 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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.;Secondary Objective: - Incidencia de episodios tromboembólicos<br>- Hemorragias en otras localizaciones<br>- Severidad de los episodios de recurrencia hemorrágica <br>- Necesidades transfusionales<br>- Identificación de factores de riesgo asociados<br>- Mortalidad;Primary end point(s): Digestive bleeding incidence;Timepoint(s) of evaluation of this end point: 2 years

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Mortality<br>- Severity of the recurrence<br>- Incidence tromboembolism<br>- Asotiation with AINEs, aspirin AAs or other antiagregants.<br>- Complications of treatment;Timepoint(s) of evaluation of this end point: 2 years