Safety and Efficacy of Bemiparin in the Prevention of Thrombotic Events in Hospitalized Cirrhotic Patients

• Status: Unknown status
• Trial end date: 2019-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Prospectively evaluation of the incidence of thromboembolic events in hospitalized cirrhotic patients. 2. Efficacy and safety of use of bemiparin in preventing peripheral and portal thrombosis. 3. Monitoring antiXa levels.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Instituto de Investigación Marqués de Valdecilla
• Treatments: Bemiparin; Heparin, Low-Molecular-Weight

Criteria

Inclusion Criteria:

1. Liver cirrhosis of any etiology diagnosed by previous biopsy or clinical, laboratory and sonographic criteria

2. Hospital admission at least 3 days, because of decompensated liver disease (ascites, encephalopathy, controlled gastrointestinal bleeding, spontaneous bacterial peritonitis)

3. signed written consent

4. Women of child-bearing age use effective contraception

Exclusion Criteria:

1. Age <18 and >80 years

2. contraindication to treatment with heparins

3. uncontrolled hemorrhage

4. Any comorbidity involving a therapeutic limitation and / or a life expectancy <6 months

5. concomitant antiplatelet therapy (aspirin, clopidogrel, ticlopidine, dipyridamole, sulfinpyrazone, dextran 40, or other anticoagulants

6. and continued concomitant NSAIDs, salicylates, corticosteroids

7. existence of clinically significant esophageal varices / severe gastropathy of portal hypertension without their having been previously treated with primary / secondary prophylaxis (endoscopic variceal ligation / non cardioselective beta blockers)

8. Refusal to participate in the study, or to sing informed consent

9. Pregnancy or lactation

10. HIV infection

11. platelet count <20,000 platelets / dl

12. renal clearance below 30ml / min

13. portal vein thrombosis or peripheral thrombosis diagnosed at admission

14. presence of procoagulant factor previously known