Cirrhosis and CoagulationPhase 3BEMI-2015NCT02802605
Safety and Efficacy of Bemiparin in the Prevention of Thrombotic Events in Hospitalized Cirrhotic Patients
A Phase 3 study testing Bemiparin in people with Cirrhosis and Coagulation, run by Instituto de Investigación Marqués de Valdecilla.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cirrhosis and Coagulation
- What is being tested?
- Bemiparin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- No sites listed yet
- Study dates
- May 2016to Jun 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
About this study
Official title: 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.
Read the 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.
- Conditions
- Cirrhosis and Coagulation
- Being tested
- Bemiparin
- Medical subject headings
- Fibrosis, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BemiparinDrug
Bemiparin subcutaneus administration
| Study group | Role | What they receive |
|---|---|---|
| Bemiparin | Experimental | Bemiparin 3.500 U, once a day during hospitalization Receives: Drug: Bemiparin |
| No drug | No intervention | Clinical practice as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 90 days
Secondary outcomes (1)
Number of thrombotic events in cirrhotic hospitalized patients
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2016 (estimated)
- Study startMay 2016
- Primary completionJun 2017 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cirrhosis and CoagulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Marqués de Valdecilla
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02802605
- Sponsor's protocol ID
- BEMI-2015
- Acronym
- BEMI-2015
- Status last verified
- Jun 2016
- First submitted
- 31 May 2016
- Last updated
- 16 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized and Controlled Trial on the Safety and Efficacy of Bemiparin in the Prevention of Thrombotic Events in Hospitalized Cirrhotic Patients
- ClinicalTrials.gov ID
- NCT02802605
- Acronym / sponsor ID
- BEMI-2015 / BEMI-2015
- Conditions
- Cirrhosis and Coagulation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- Instituto de Investigación Marqués de ValdecillaUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 16 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bemiparin | Experimental | Drug: BemiparinBemiparin 3.500 U, once a day during hospitalization |
| No drug | No intervention | –Clinical practice as usual |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BemiparinBemiparin subcutaneus administration | Drug | Bemiparin |
Primary outcome
Number of patients with bleeding and liver toxicity under Bemiparin treatment (HIBOR®) for the prevention of DVT / portal vein thrombosis.
Time frame: 90 days
The bleeding will be classificated in two grades ( mild/ severe) and hepatoxicty were asses according to NCI CTCAE Version 3.0
1 secondary outcome
Number of thrombotic events in cirrhotic hospitalized patients
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bemiparin in people with Cirrhosis and Coagulation, run by Instituto de Investigación Marqués de Valdecilla.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with bleeding and liver toxicity under Bemiparin treatment (HIBOR®) for the prevention of DVT / portal vein thrombosis. (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2016.