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

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

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.

Study Overview

• Status: Unknown
• Conditions: Cirrhosis and Coagulation
• Intervention / Treatment: Drug: Bemiparin

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.

• Study Type: Interventional
• Enrollment (Anticipated): 225
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bemiparin; Bemiparin 3.500 U, once a day during hospitalization	Drug: Bemiparin; Bemiparin subcutaneus administration
No Intervention: No drug; Clinical practice as usual

What is the study measuring?

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	Time Frame
Number of thrombotic events in cirrhotic hospitalized patients	90 days

Collaborators and Investigators

• Sponsor: Instituto de Investigación Marqués de Valdecilla

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Anticipated): June 1, 2017
• Study Completion (Anticipated): June 1, 2019

Study Registration Dates

• First Submitted: May 31, 2016
• First Submitted That Met QC Criteria: June 13, 2016
• First Posted (Estimate): June 16, 2016

Study Record Updates

• Last Update Posted (Estimate): June 16, 2016
• Last Update Submitted That Met QC Criteria: June 13, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis; Anticoagulants; Bemiparin
• Other Study ID Numbers: BEMI-2015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No