Compare VKA vs LMWH in Patients With Anticoagulation Criteria and Episode of Gastrointestinal Bleeding.

• Status: Completed
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: All

Summary

SUMMARY

1.0. Type of Application: Clinical trial comparing two treatments in terms of authorized use.

1.1. Promoter: Institute of Research, Hospital de la Santa Creu i Sant Pau. Avgda. Sant Antoni M.Claret, 167. 08025 Barcelona. Tel: [phone] 291 21 73.

1.2. Title: Randomized controlled trial to compare treatment with oral anticoagulation with antagonists of vitamin K versus low molecular weight heparin (Bemiparin) in patients with anticoagulation criteria and who have had an episode of gastrointestinal bleeding.

1.3. Protocol code: HEPACO 1.4. Principal Investigators: Dr. Candid Villanueva Sanchez. Dr. Jose Mateo Arranz. Contributors: Dr. Alicia Brotons (Service of Digestive Pathology), Dr. Angela Puente (service of Digestive Pathology), Dr. Isabel Graupera (Service of Digestive Pathology) and Dr. Marina Carrasco (Hematology Service). Hospital de la Santa Creu i Sant Pau. Avgda. Sant Antoni Maria Claret, 167. 08025 Barcelona. Tel: [phone]. Fax: [phone].

E-mail:[email protected]. 1.5. Centers that are planned for the trial: Service Gastroenterology and Hematology Service of the Sant Creu i Sant Pau, Barcelona.

1.6. Clinical Research Ethics Committee: Hospital de la Santa Creu i Sant Pau. 1.7. Monitor:

Institute for Research (CAIBER) of the Hospital de Sant Pau. Avgda. Sant Antoni M.Claret, 167. 08025 Barcelona. Tel: [phone].

1.8. Drugs: warfarin, bemiparin. 1.9. Development stage: Clinical Trial phase IV 1.10. Main objective: To compare the incidence of gastrointestinal rebleeding and safety of oral anticoagulation versus low molecular weight heparin in patients who have had an acute gastrointestinal bleeding and have indication for anticoagulation.

1.11. Design: prospective open clinical trial, randomized and controlled. 1.12. Study disease: acute gastrointestinal bleeding. 1.13. Primary endpoint of the valoration: Incidence of gastrointestinal bleeding.

1.14. Study population and total number of patients: 20 patients were required in each group (40 total) to objectify a decrease of rebleeding rate of 45% with an alpha error of 5% and 10% beta.

1.15. Treatment duration: 2 years. 1.16. Calendar and expected completion date: July 2011 - July 2013

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Treatments: Dalteparin; Heparin, Low-Molecular-Weight; Warfarin

Criteria

Inclusion Criteria:patients with anticoagulant treatment criteria (treated with acenocoumarol or warfarin) and high or very high risk of embolism, who have an acute gastrointestinal bleeding (high or low) endoscopically untreatable, secondary to multiple vascular lesions, diverticular origin or unclarified origin (after VGC and DC) who have no exclusion criteria.

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Exclusion Criteria:Not be included patients with one or more of the following criteria:

A) less than 18 years old. B) pregnancy. C) patient refusal to participate in the study. D) patients in whom the decision has been taken not to provide active treatment for the existence of any clinical situation considered terminal (severe associated diseases evolved).

E) Contraindication LMWH (allergy, heparin induced thrombocytopenia). F) bleeding secondary to esophageal varices and / or gastric. G) associated bleeding peptic injury. H) bleeding secondary to tumors or polyps. i) Presence of portal hypertension with or without cirrhosis. J) bleeding due to Mallory-Weiss syndrome. K) anticoagulation for low risk embolic lesions

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