Clinical trial NCT02802605: Safety and Efficacy of Bemiparin in the Prevention of Thrombotic Events in Hospitalized Cirrhotic Patients
Official title: Randomized and Controlled Trial on the Safety and Efficacy of Bemiparin in the Prevention of Thrombotic Events in Hospitalized Cirrhotic Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Cirrhosis and Coagulation
Lead sponsor: Instituto de Investigación Marqués de Valdecilla
Sponsor class: OTHER
First posted: 2016-06-16
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Number of patients with bleeding and liver toxicity under Bemiparin treatment (HIBOR®) for the prevention of DVT / portal vein thrombosis.
timeFrame: 90 days
Secondary outcomes:
measure: Number of thrombotic events in cirrhotic hospitalized patients
timeFrame: 90 days
Other outcomes:
Locations:
Study officials:
References: