Ignite Creation Date:
2025-12-26 @ 10:36 AM
Ignite Modification Date:
2025-12-29 @ 2:29 PM
Study NCT ID:
NCT01308528
Status:
COMPLETED
Last Update Posted:
2017-07-19
First Post:
2011-03-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prophylactic Use of Sodium Enoxaparin for Venous Thromboembolism in High-Risk Abdominal Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054556', 'term': 'Venous Thromboembolism'}], 'ancestors': [{'id': 'D013923', 'term': 'Thromboembolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000711671', 'term': 'enoxaparin sodium'}, {'id': 'D017984', 'term': 'Enoxaparin'}], 'ancestors': [{'id': 'D006495', 'term': 'Heparin, Low-Molecular-Weight'}, {'id': 'D006493', 'term': 'Heparin'}, {'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 243}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-18', 'studyFirstSubmitDate': '2011-03-01', 'studyFirstSubmitQcDate': '2011-03-02', 'lastUpdatePostDateStruct': {'date': '2017-07-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-03-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of Sodium enoxaparin to demonstrate non-inferiority', 'timeFrame': '10 Days', 'description': 'Evaluation of Prophylactic use of Sodium enoxaparin to demonstrate non-inferiority for Venous Thromboembolism in High-Risk Surgery in Abdominal'}], 'secondaryOutcomes': [{'measure': 'Safety of sodium enoxaparine', 'timeFrame': '10 days', 'description': 'comparision between Endocris (sodium enoxaparin - Cristalia Prod. Quim. Farm.) versus Clexane (sodium enoxaparine - Sanofi-Aventis) in High-Risk Abdominal Surgery.'}, {'measure': 'Compare the incidence of venous thromboembolism and pulmonar embolism', 'timeFrame': '10 days', 'description': 'Compare the incidence of venous thromboembolism and pulmonar embolism between 2 groups after 30 days of surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Venous Thromboembolism'], 'conditions': ['Venous Thromboembolism']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the safety and security and efficacy of sodium enoxaparin Cristália Produtos Químicos Farmaceuticos Ltda - Endocris with Clexane (Sanofi-Aventis) to prevent Venous Thromboembolism in Patients With High-Risk to Develop Thromboembolic Disease Undergoing Geral Abdominal Surgery.', 'detailedDescription': 'This study is a requirement of Anvisa to add a new indication for off-label drug'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women aged above 18 years undergoing abdominal surgery with general high risk for developing venous thromboembolism;\n* Who have provided their consent by signing the consent form.\n\nExclusion Criteria:\n\n* Clinical evidence of Venous thromboembolism (VTE) in the selection;\n* treatment requirement with anticoagulant Low Molecular Weight Heparin, Unfracted Heparin, oral anticoagulant\n* suspicion or history of coagulumpathia\n* Heparin, enoxaparin allergy or hypersensitiviy known to heparin, enoxaparin, but not restrict to thrombocytopenia and/or induce thombose by heparin ou enoxaparin (thrombocytopenia induce by heparin \\[TIH\\], thrombocytopenia associate with heparin \\[TAH\\] or thrombotic thrombocytopenia syndrome induce by heparin \\[STTIH\\]\n* Active bleeding that can be increased by enoxaparin.\n* Previous history of known intracranial hemorrhage\n* Artery-venous malformation or a suspicion or known cerebral aneurism\n* Spinal, Epidural ou lumbar puncture analgesia in the last 24 hours previous of the first dose of the administration of the enoxaparin.\n* erosive diseases of the digestive tract especially gastroduodenal\n* Uncontrolled hypertension (systolic blood pressure \\[BP\\]\\> 180mmHg or diastolic BP\\> 100 mm Hg) at randomization or clinical hypertensive urgency;\n* bacterial endocarditis\n* heart valve prosthesis\n* characterized by severe renal insufficiency creatinine clearance \\<30 ml / min\n* Intra-arterial thrombolic therapy\n* Thrombolic therapy within 24 hours.\n* Low Molecular Weight Heparin or Unfraction Heparin treatment with prophylactic dose over 48 hours before surgery or oral anticoagulant within 5 days before surgery\n* disturbance of consciousness and coma\n* Less than 6 months of expectative time life\n* Chemical dependency\n* Patient with anesthetic risk ASA III or ASA IV\n* morbid obesity with Body Mass Index ≥ 40\n* Chronic use of corticosteroids\n* History of allergy to Unfraction Heparin, Low molecular weight heparin or pork products.\n* History of severe allergic episode, systemic anaphylaxis, or major urticarial disease Steven-Johnson\n* Participation in another clinical study within 12 months prior to inclusion\n* Potentially fertile woman without β-HCG negative harvested until 48 hours before operation or not using acceptable contraception for participation in this study\n* Changes the security checks up to 48 h before randomization:\n\n * Hemoglobin \\<10 mg / dL;\n * ALT or AST ≥ 2.5 times ULN;\n * Platelet count \\<100.000/mL;\n * INR ≥ 1.5;\n* Any condition which in the opinion of the investigator, could lead to increased risk for the patient or who makes it inappropriate for this study.'}, 'identificationModule': {'nctId': 'NCT01308528', 'briefTitle': 'Prophylactic Use of Sodium Enoxaparin for Venous Thromboembolism in High-Risk Abdominal Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cristália Produtos Químicos Farmacêuticos Ltda.'}, 'officialTitle': 'A Non-Inferiority Study of Enoxaparin Cristalia in Relation With Enoxaparin Sanofi-Aventis for Prophylaxis Against Venous Thromboembolism in Patients With High-Risk to Develop Thromboembolic Disease Undergoing Geral Abdominal Surgery', 'orgStudyIdInfo': {'id': 'CRT062'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sodium enoxaparin', 'description': 'Endocris - 40 mg/0,4mL', 'interventionNames': ['Drug: Sodium enoxaparin']}, {'type': 'EXPERIMENTAL', 'label': 'sodium enoxaparin Clexane', 'description': 'Clexane - 40 mg/ 0,4mL', 'interventionNames': ['Drug: Sodium Enoxaparin clexane']}], 'interventions': [{'name': 'Sodium enoxaparin', 'type': 'DRUG', 'otherNames': ['Endocris'], 'description': '40 mg/mL', 'armGroupLabels': ['Sodium enoxaparin']}, {'name': 'Sodium Enoxaparin clexane', 'type': 'DRUG', 'otherNames': ['clexane'], 'description': 'clexane 40 mg/ 0,4 mL', 'armGroupLabels': ['sodium enoxaparin Clexane']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Brasília', 'state': 'Federal District', 'country': 'Brazil', 'facility': 'Hospital Regional da Asa Norte', 'geoPoint': {'lat': -15.77972, 'lon': -47.92972}}, {'zip': '92425-900', 'city': 'Canoas', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Huning Instituto de Oftalmologia e Pesquisa HIOP/HRPC', 'geoPoint': {'lat': -29.91778, 'lon': -51.18361}}, {'zip': '90035-903', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Hospital de Clínicas de Porto Alegre', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'zip': '90610-000', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Hospital São Lucas da PUCRS', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'zip': '13083-970', 'city': 'Campinas', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Fundação de Desenvolvimento da Unicamp - FUNCAMP', 'geoPoint': {'lat': -22.90556, 'lon': -47.06083}}, {'zip': '14015-130', 'city': 'Ribeirão Preto', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital das Clínicas de Riberião Preto', 'geoPoint': {'lat': -21.1775, 'lon': -47.81028}}, {'zip': '09190615', 'city': 'Santo André', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital Estadual Mario Covas', 'geoPoint': {'lat': -23.66389, 'lon': -46.53833}}, {'zip': '09780000', 'city': 'São Bernardo do Campo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Centro Multidisciplinar de Estudos Clínicos', 'geoPoint': {'lat': -23.69389, 'lon': -46.565}}, {'zip': '15090-000', 'city': 'São Jósé Do Rio Preto', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Fundação Faculdade Regional de Medicina de São José do Rio Preto'}], 'overallOfficials': [{'name': 'Gilson R de Araujo, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Regional da Asa Norte'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cristália Produtos Químicos Farmacêuticos Ltda.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}