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

NCT ID: NCT02802605

Last Updated: 2016-06-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 225 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2019-06-30

Brief 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.

Detailed Description

PRIMARY OBJECTIVE: To evaluate the safety of prophylactic anticoagulation Bemiparina (HIBOR®) for the prevention of peripheral and portal vein thrombosis in cirrhotic patients with prolonged hospitalization.

Secondary objectives are the following:

1. To evaluate the incidence of thrombotic events in hospitalized cirrhotic patients.

2. To evaluate the efficacy of low molecular weight heparin (HIBOR 3.500UI) in preventing thrombotic events in hospitalized cirrhotic patients.

3. To identify risk factors for development of portal vein thrombosis and deep vein thrombosis in hospitalized patients.

4. Evaluate the morbidity and mortality associated with thromboembolic events.

5. Evaluate prophylactic anticoagulation levels by determining antiXa and antithrombin III.

6. To study the expression profile and functionality of Toll-like receptors as factors intimately involved in the inflammatory response, as well as the variability of different serum markers associated with proinflammatory state: I-FABP / IL6-IL8 / NO, endothelin and LPS-binding protein.

7. Evaluate the effect on liver fibrosis (by Fibroscan®) and serum TGF

8. Evolution of hepatocellular function estimated by the scores of Child-Pugh and MELD.

Conditions

Cirrhosis and Coagulation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Bemiparin

Bemiparin 3.500 U, once a day during hospitalization

Group Type: EXPERIMENTAL

Bemiparin

Intervention Type: DRUG

Bemiparin subcutaneus administration

No drug

Clinical practice as usual

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Bemiparin

Bemiparin subcutaneus administration

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto de Investigación Marqués de Valdecilla

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

BEMI-2015

Identifier Type: -

Identifier Source: org_study_id