Ignite Creation Date:
2025-12-24 @ 2:52 PM
Ignite Modification Date:
2025-12-27 @ 10:10 AM
Study NCT ID:
NCT00894959
Status:
COMPLETED
Last Update Posted:
2013-02-25
First Post:
2009-05-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Sodium Heparin in Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 104}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-22', 'studyFirstSubmitDate': '2009-05-05', 'studyFirstSubmitQcDate': '2009-05-06', 'lastUpdatePostDateStruct': {'date': '2013-02-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-05-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of TTPA, Anti-Xa and ACT', 'timeFrame': 'Pre - Operative (T0) Pre Heparinization (T1) Top of Extracorporeal (T2) Period Intraoperative (T3) Termination Extracorporeal (T4) Postoperative'}, {'measure': 'Comparison of bleeding', 'timeFrame': 'Pre - Operative (T0) Pre Heparinization (T1) Top of Extracorporeal (T2) Period Intraoperative (T3) Termination Extracorporeal (T4) Postoperative'}], 'secondaryOutcomes': [{'measure': 'Adverse reactions', 'timeFrame': 'Pre - Operative (T0) Pre Heparinization (T1) Top of Extracorporeal (T2) Period Intraoperative (T3) Termination Extracorporeal (T4) Postoperative'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['heparin cardiac surgery'], 'conditions': ['Cardiac Surgery']}, 'descriptionModule': {'briefSummary': 'The objective of this study is verify, through a randomized, single-blind, multicentre, parallel and comparative study, the effectiveness of heparin sodium of porcine origin in patients undergoing heart surgery at that require the aid of cardiopulmonary bypass, through the control of hemostasis during and after surgery, based on the strengths of markers of coagulation TCA, TTPA, Anti-Xa, heparin bioavailable and loss of excessive blood (bleeding) at the end of the surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who agree with all aspects of the study and sign the FICT;\n* Patients of both sexes;\n* Patients aged above 18 years;\n* Patients with cardiac surgery and requiring movement; AND\n* Extracorporeal.\n\nExclusion Criteria:\n\n* Patients with hematological disorders that compromise the surgical changes (eg myeloproliferative syndromes, anemia Hb \\<11.0 g / dL,\n* Platelets \\< 150,000 mm3);\n* Patients with disorders of hemostasis (INR\\> 1.40) (rTTPA\\> 1.40);\n* Patients with renal dysfunction (creatinine\\> 1.50);\n* Patients with deep hyperthermia;\n* Liver disease (AST and ALT\\> 2 times that of the reference value);\n* Patients with a history of allergy to heparin or protamine;\n* Patients with history of heparin-induced thrombocytopenia;\n* Tables infection (eg endocarditis, infection of immune human (HIV), hepatitis B and C, septicemia and pneumonia);\n* Reoperations;\n* Use of antiplatelet (clopidogrel and ticlopidine) for less than 7 days;\n* Use of acetylsalicylic acid is less than 5 days;\n* Use of low molecular weight heparin for less than 24 hours; OR\n* Use of non-fractioned heparin for less than 12 hours.'}, 'identificationModule': {'nctId': 'NCT00894959', 'briefTitle': 'Efficacy and Safety of Sodium Heparin in Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Azidus Brasil'}, 'officialTitle': 'Randomized Clinical Trial of Sodium Heparin Effectiveness and Security in Patients Submitted to Heart Surgery Using Bypass', 'orgStudyIdInfo': {'id': 'HEPSBCCV0109_BLA1'}, 'secondaryIdInfos': [{'id': 'Heparin Blausiegel 1'}, {'id': '(Version 8)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Heparin Sodium Blausiegel 1', 'interventionNames': ['Biological: Heparin sodium Blausiegel 1']}, {'type': 'EXPERIMENTAL', 'label': 'Active Comparator', 'description': 'heparin sodium - APP 5.000 USP', 'interventionNames': ['Biological: Heparin sodium APP']}], 'interventions': [{'name': 'Heparin sodium Blausiegel 1', 'type': 'BIOLOGICAL', 'description': 'Heparin sodium Blausiegel 1 5.000 UI', 'armGroupLabels': ['1']}, {'name': 'Heparin sodium APP', 'type': 'BIOLOGICAL', 'description': 'Heparin sodium APP 5.000 USP', 'armGroupLabels': ['Active Comparator']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13270000', 'city': 'Valinhos', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'LAL clinica pesquisa e desenvolvimento ltda', 'geoPoint': {'lat': -22.97056, 'lon': -46.99583}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azidus Brasil', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Alexandre Frederico', 'oldOrganization': 'LAL Clínica Pesquisa e Desenvolvimento Ltda'}}}}