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

Study Overview
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Brief Summary
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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
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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: To evaluate the incidence of thrombotic events in hospitalized cirrhotic patients. To evaluate the efficacy of low molecular weight heparin (HIBOR 3.500UI) in preventing thrombotic events in hospitalized cirrhotic patients. To identify risk factors for development of portal vein thrombosis and deep vein thrombosis in hospitalized patients. Evaluate the morbidity and mortality associated with thromboembolic events. Evaluate prophylactic anticoagulation levels by determining antiXa and antithrombin III. 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. Evaluate the effect on liver fibrosis (by Fibroscan®) and serum TGF Evolution of hepatocellular function estimated by the scores of Child-Pugh and MELD.

Official Title
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Randomized and Controlled Trial on the Safety and Efficacy of Bemiparin in the Prevention of Thrombotic Events in Hospitalized Cirrhotic Patients

Conditions
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Cirrhosis and Coagulation

Intervention / Treatment
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* Drug: Bemiparin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Liver cirrhosis of any etiology diagnosed by previous biopsy or clinical, laboratory and sonographic criteria Hospital admission at least 3 days, because of decompensated liver disease (ascites, encephalopathy, controlled gastrointestinal bleeding, spontaneous bacterial peritonitis) signed written consent Women of child-bearing age use effective contraception Exclusion Criteria: Age <18 and >80 years contraindication to treatment with heparins uncontrolled hemorrhage Any comorbidity involving a therapeutic limitation and / or a life expectancy <6 months concomitant antiplatelet therapy (aspirin, clopidogrel, ticlopidine, dipyridamole, sulfinpyrazone, dextran 40, or other anticoagulants and continued concomitant NSAIDs, salicylates, corticosteroids 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) Refusal to participate in the study, or to sing informed consent Pregnancy or lactation HIV infection platelet count <20,000 platelets / dl renal clearance below 30ml / min portal vein thrombosis or peripheral thrombosis diagnosed at admission presence of procoagulant factor previously known

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bemiparin<br>Bemiparin 3.500 U, once a day during hospitalization | Drug: Bemiparin<br>* Bemiparin subcutaneus administration<br>|
| No Intervention: No drug<br>Clinical practice as usual | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with bleeding and liver toxicity under Bemiparin treatment (HIBOR®) for the prevention of DVT / portal vein thrombosis. | The bleeding will be classificated in two grades ( mild/ severe) and hepatoxicty were asses according to NCI CTCAE Version 3.0 | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of thrombotic events in cirrhotic hospitalized patients |  | 90 days |