Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2026-02-26 @ 12:04 PM
Study NCT ID:
NCT02802605
Status:
UNKNOWN
Last Update Posted:
2016-06-16
First Post:
2016-05-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Bemiparin in the Prevention of Thrombotic Events in Hospitalized Cirrhotic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D013927', 'term': 'Thrombosis'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C411345', 'term': 'bemiparin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 225}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2019-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-06-13', 'studyFirstSubmitDate': '2016-05-31', 'studyFirstSubmitQcDate': '2016-06-13', 'lastUpdatePostDateStruct': {'date': '2016-06-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-06-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with bleeding and liver toxicity under Bemiparin treatment (HIBOR®) for the prevention of DVT / portal vein thrombosis.', 'timeFrame': '90 days', 'description': 'The bleeding will be classificated in two grades ( mild/ severe) and hepatoxicty were asses according to NCI CTCAE Version 3.0'}], 'secondaryOutcomes': [{'measure': 'Number of thrombotic events in cirrhotic hospitalized patients', 'timeFrame': '90 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cirrhosis and Coagulation']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nSecondary objectives are the following:\n\n1. To evaluate the incidence of thrombotic events in hospitalized cirrhotic patients.\n2. To evaluate the efficacy of low molecular weight heparin (HIBOR 3.500UI) in preventing thrombotic events in hospitalized cirrhotic patients.\n3. To identify risk factors for development of portal vein thrombosis and deep vein thrombosis in hospitalized patients.\n4. Evaluate the morbidity and mortality associated with thromboembolic events.\n5. Evaluate prophylactic anticoagulation levels by determining antiXa and antithrombin III.\n6. 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.\n7. Evaluate the effect on liver fibrosis (by Fibroscan®) and serum TGF\n8. Evolution of hepatocellular function estimated by the scores of Child-Pugh and MELD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Liver cirrhosis of any etiology diagnosed by previous biopsy or clinical, laboratory and sonographic criteria\n2. Hospital admission at least 3 days, because of decompensated liver disease (ascites, encephalopathy, controlled gastrointestinal bleeding, spontaneous bacterial peritonitis)\n3. signed written consent\n4. Women of child-bearing age use effective contraception\n\nExclusion Criteria:\n\n1. Age \\<18 and \\>80 years\n2. contraindication to treatment with heparins\n3. uncontrolled hemorrhage\n4. Any comorbidity involving a therapeutic limitation and / or a life expectancy \\<6 months\n5. concomitant antiplatelet therapy (aspirin, clopidogrel, ticlopidine, dipyridamole, sulfinpyrazone, dextran 40, or other anticoagulants\n6. and continued concomitant NSAIDs, salicylates, corticosteroids\n7. 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)\n8. Refusal to participate in the study, or to sing informed consent\n9. Pregnancy or lactation\n10. HIV infection\n11. platelet count \\<20,000 platelets / dl\n12. renal clearance below 30ml / min\n13. portal vein thrombosis or peripheral thrombosis diagnosed at admission\n14. presence of procoagulant factor previously known'}, 'identificationModule': {'nctId': 'NCT02802605', 'acronym': 'BEMI-2015', 'briefTitle': 'Safety and Efficacy of Bemiparin in the Prevention of Thrombotic Events in Hospitalized Cirrhotic Patients', 'organization': {'class': 'OTHER', 'fullName': 'Instituto de Investigación Marqués de Valdecilla'}, 'officialTitle': 'Randomized and Controlled Trial on the Safety and Efficacy of Bemiparin in the Prevention of Thrombotic Events in Hospitalized Cirrhotic Patients', 'orgStudyIdInfo': {'id': 'BEMI-2015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bemiparin', 'description': 'Bemiparin 3.500 U, once a day during hospitalization', 'interventionNames': ['Drug: Bemiparin']}, {'type': 'NO_INTERVENTION', 'label': 'No drug', 'description': 'Clinical practice as usual'}], 'interventions': [{'name': 'Bemiparin', 'type': 'DRUG', 'description': 'Bemiparin subcutaneus administration', 'armGroupLabels': ['Bemiparin']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto de Investigación Marqués de Valdecilla', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}