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
1 other identifier
interventional
225
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started May 2016
Typical duration for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2016
CompletedFirst Submitted
Initial submission to the registry
May 31, 2016
CompletedFirst Posted
Study publicly available on registry
June 16, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2019
CompletedJune 16, 2016
June 1, 2016
1.1 years
May 31, 2016
June 13, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Number of thrombotic events in cirrhotic hospitalized patients
90 days
Study Arms (2)
Bemiparin
EXPERIMENTALBemiparin 3.500 U, once a day during hospitalization
No drug
NO INTERVENTIONClinical practice as usual
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 31, 2016
First Posted
June 16, 2016
Study Start
May 1, 2016
Primary Completion
June 1, 2017
Study Completion
June 1, 2019
Last Updated
June 16, 2016
Record last verified: 2016-06
Data Sharing
- IPD Sharing
- Will not share