Prevention of thrombosis in cirrhotic patients MedDRA version: 18.1 Level: HLGT Classification code 10014523 Term: Embolism and thrombosis System Organ Class: 10047065 - Vascular disorders
Conditions
Interventions
Trade Name: HIBOR 3500 UI
Product Name: HIBOR 3500 UI
Pharmaceutical Form: Solution for injection
INN or Proposed INN: BEMIPARIN SODIUM
Sponsors
ANGELA PUENTE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Applicants must meet all the following: 1) Liver cirrhosis of any etiology diagnosed by biopsy or after clinical, laboratory and ultrasound criteria; 2) Admission to hospital more than 3 days of their liver decompensation (ascites, encephalopathy, upper gastrointestinal bleeding or low controlled, spontaneous bacterial peritonitis) 3) signed written consent.4) women in childbearing age with use of effective contraception Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 200 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
Exclusion criteria: One or more of the following: 1) Age 80 years; 2) contraindication to heparin treatment of low molecular weight, 3) uncontrolled bleeding 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 sign the informed consent; 9) Pregnancy and lactation; 10) HIV infection; 11) severe thrombocytopenia <20,000 platelets / dl, 12) Failure to severe with lower clearance 30ml / min Renal 13) portal vein thrombosis or peripheral thrombosis diagnosed on admission, 14) Presence of previously known procoagulant factor
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Related peripheral and portal thrombosis;Timepoint(s) of evaluation of this end point: 3 months | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety and efficacy of prophylactic anticoagulation for the prevention of thrombotic events in hospitalized cirrhotic patients; Secondary Objective: 1.To assess prospectively the incidence of thrombotic events in hospitalized cirrhotic patients. 2. To assess the efficacy of low molecular weight heparin (HIBOR 3.500UI) in preventing thrombotic events in cirrhotic patients hospitalized. 3. To Identify risk factors for development of portal vein thrombosis and deep vein thrombosis in hospitalized patients. 4.To evaluate related morbidity and mortality thromboembolic events. 5. To Assess prophylactic anticoagulation levels by determining antiXa and antithrombin III. 6. To study the expression profile and functionality of the family of Toll-like receptors, I-FABP / IL6-IL8 / NO, endothelin and LPS-binding protein. 7. To evaluate the effect on liver fibrosis (by FibroScan®) and serum TGFB 8. To study the hepatocellular function estimated by the Child-Pugh scores and MELD ; Primary end point(s): Security prophylactic anticoagulation with Bemiparin (HIBOR®) for the prevention of vein thrombosis in patients with prolonged hospitalization ;Timepoint(s) of evaluation of this end point: 3 months | — |
Countries
Spain
Contacts
Public ContactANGELA
ANGELA PUENTE
Outcome results
None listed