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

Primary Purpose

Cirrhosis and Coagulation

Status

Unknown status

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Bemiparin

About this trial

This is an interventional prevention trial for Cirrhosis and Coagulation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Bemiparin

No drug

Arm Description

Bemiparin 3.500 U, once a day during hospitalization

Clinical practice as usual

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of thrombotic events in cirrhotic hospitalized patients

Full Information

NCT ID

NCT02802605

First Posted

May 31, 2016

Last Updated

June 13, 2016

Sponsor

Instituto de Investigación Marqués de Valdecilla

1. Study Identification

Unique Protocol Identification Number

NCT02802605

Brief Title

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

Acronym

BEMI-2015

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

2. Study Status

Record Verification Date

June 2016

Overall Recruitment Status

Unknown status

Study Start Date

May 2016 (undefined)

Primary Completion Date

June 2017 (Anticipated)

Study Completion Date

June 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Instituto de Investigación Marqués de Valdecilla

4. Oversight

Data Monitoring Committee

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cirrhosis and Coagulation

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

225 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Bemiparin

Arm Type

Experimental

Arm Description

Bemiparin 3.500 U, once a day during hospitalization

Arm Title

No drug

Arm Type

No Intervention

Arm Description

Clinical practice as usual

Intervention Type

Drug

Intervention Name(s)

Bemiparin

Intervention Description

Bemiparin subcutaneus administration

Primary Outcome Measure Information:

Title

Number of patients with bleeding and liver toxicity under Bemiparin treatment (HIBOR®) for the prevention of DVT / portal vein thrombosis.

Description

The bleeding will be classificated in two grades ( mild/ severe) and hepatoxicty were asses according to NCI CTCAE Version 3.0

Time Frame

90 days

Secondary Outcome Measure Information:

Title

Number of thrombotic events in cirrhotic hospitalized patients

Time Frame

90 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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