Randomized controlled trial to compare treatment with oral anticoagulation with vitamin K antagonists versus low molecular weight heparin (bemiparin) in patients with anticoagulation criteria and have an episode of gastrointestinal bleeding. - HEPACO

Institut de Recerca HSCSP0 sitesSeptember 15, 2011

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Patients with gastrointestinal bleeding are not candidates for endoscopic treatment with oral anticoagulant previously.
Sponsor: Institut de Recerca HSCSP
Status: Active, not recruiting
Last Updated: 9 years ago

No summary available.

Registry

who.int

Start Date

September 15, 2011

End Date

TBD

Last Updated

9 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Institut de Recerca HSCSP

•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

•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.