NCT02802605

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

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 225 (estimated)
• Sponsor: Instituto de Investigación Marqués de Valdecilla · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Bemiparin	Bemiparin subcutaneus administration

Timeline

• Start date: 2016-05-01
• Primary completion: 2017-06-01
• Completion: 2019-06-01
• First posted: 2016-06-16
• Last updated: 2016-06-16