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

I

Instituto de Investigación Marqués de Valdecilla

Status and phase

Unknown
Phase 3

Conditions

Cirrhosis and Coagulation

Treatments

Drug: Bemiparin

Study type

Interventional

Funder types

Other

Identifiers

NCT02802605
BEMI-2015

Details and patient eligibility

About

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.

Full 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.

Enrollment

225 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

225 participants in 2 patient groups

Bemiparin
Experimental group
Description:
Bemiparin 3.500 U, once a day during hospitalization
Treatment:
Drug: Bemiparin
No drug
No Intervention group
Description:
Clinical practice as usual

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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