Safety and Efficacy of Bemiparin in the Prevention of Thrombotic Events in Hospitalized Cirrhotic Patients (BEMI-2015)

Instituto de Investigación Marqués de Valdecilla

Status and phase: Unknown; Phase 3

Conditions: Cirrhosis and Coagulation

Treatments: Drug: Bemiparin

Study type: Interventional

Funder types: Other

Identifiers

NCT02802605

BEMI-2015

Details and patient eligibility

About

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.

Full 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.

Enrollment: 225 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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225 participants in 2 patient groups

Bemiparin

Experimental group

Description:

Bemiparin 3.500 U, once a day during hospitalization

Treatment:

Drug: Bemiparin

No drug

No Intervention group

Description:

Clinical practice as usual