Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2025-12-26 @ 2:13 AM
Study NCT ID:
NCT01267305
Status:
COMPLETED
Last Update Posted:
2014-04-29
First Post:
2010-12-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Impact of Different Anticoagulant Therapy on Hemorrhage and Coagulation After Thoracic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D004938', 'term': 'Esophageal Neoplasms'}, {'id': 'D054556', 'term': 'Venous Thromboembolism'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013923', 'term': 'Thromboembolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077425', 'term': 'Fondaparinux'}, {'id': 'D017762', 'term': 'Nadroparin'}], 'ancestors': [{'id': 'D009844', 'term': 'Oligosaccharides'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D006495', 'term': 'Heparin, Low-Molecular-Weight'}, {'id': 'D006493', 'term': 'Heparin'}, {'id': 'D006025', 'term': 'Glycosaminoglycans'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 362}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-28', 'studyFirstSubmitDate': '2010-12-25', 'studyFirstSubmitQcDate': '2010-12-25', 'lastUpdatePostDateStruct': {'date': '2014-04-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-12-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'TEG values', 'timeFrame': 'three days after surgery', 'description': '1.5ml aterial blood sample will be obtained daily for TEG , and the vulues of TEG,such as R,K,Alpha angle,MA,G,CI ,will be measured'}], 'secondaryOutcomes': [{'measure': 'bleeding quantity of chest drainage', 'timeFrame': 'three days after surgery', 'description': 'all drain from chest tube are gathered and hematocrits are measured to calculate the quantities of bleeding'}, {'measure': 'incidence rate of deep venous thromboembolism（DVT)', 'timeFrame': 'after surgery up to 7 days', 'description': 'incidence of DVT is measured by vascular ultrasonography'}, {'measure': 'inhospital mortality', 'timeFrame': 'after surgery up to 28 days', 'description': 'the number of death in the period of hospital stay'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['esophagectomy', 'lung resection', 'venous thromboembolism', 'low molecular weight heparin', 'chest drainage', 'TEG'], 'conditions': ['Lung Neoplasms', 'Esophageal Neoplasms', 'Venous Thromboembolism']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether the use of different dose of LMWH compared with fondaparinux for thromboprophylaxis is efficacious and safety after thoracic surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* clinical diagnosis of esophageal carcinoma and planned for esophagectomy\n* clinical diagnosis of lung carcinoma and planned for lung resection\n* general anesthesia combined with epidural anesthesia\n\nExclusion Criteria:\n\n* blood clotting disfunction before surgery\n* anticoagulating or antiplatelet history before surgery\n* low blood platelets count\n* hemorrhagic disease\n* cerebral hemorrhage\n* cerebral,spinal,ophthalmologic operation history\n* peptic ulcer\n* bleeding\\>400ml in operation\n* bleeding\\>100ml/h after operation\n* blood transfusion in or after operation\n* severe renal or liver disfunction\n* severe hypertension'}, 'identificationModule': {'nctId': 'NCT01267305', 'briefTitle': 'The Impact of Different Anticoagulant Therapy on Hemorrhage and Coagulation After Thoracic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Zhongshan Hospital'}, 'officialTitle': 'The Impact of Different Anticoagulant Therapy on Hemorrhage and Coagulation After Thoracic Surgery', 'orgStudyIdInfo': {'id': 'SICUTEG-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'lung lmwh1', 'description': 'use LMWH once daily after lung resection', 'interventionNames': ['Drug: Nadroparin Calcium']}, {'type': 'EXPERIMENTAL', 'label': 'lung lmwh2', 'description': 'use LMWH twice daily after lung resection', 'interventionNames': ['Drug: Nadroparin Calcium']}, {'type': 'EXPERIMENTAL', 'label': 'lung Fondaparinux', 'description': 'use Fondaparinux once daily after lung resection', 'interventionNames': ['Drug: Fondaparinux']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'eso lmwh1', 'description': 'use LMWH once daily after esophagectomy', 'interventionNames': ['Drug: Nadroparin Calcium']}, {'type': 'EXPERIMENTAL', 'label': 'eso lmwh2', 'description': 'use LMWH twice daily after esophagectomy', 'interventionNames': ['Drug: Nadroparin Calcium']}, {'type': 'EXPERIMENTAL', 'label': 'eso Fondaparinux', 'description': 'use Fondaparinux once daily after esophagectomy', 'interventionNames': ['Drug: Fondaparinux']}], 'interventions': [{'name': 'Fondaparinux', 'type': 'DRUG', 'otherNames': ['ARIXTRA', 'H20080111'], 'description': '2.5mg IH qd(8AM) after operation', 'armGroupLabels': ['eso Fondaparinux', 'lung Fondaparinux']}, {'name': 'Nadroparin Calcium', 'type': 'DRUG', 'otherNames': ['Fraxiparine'], 'description': '4100AxaIU IH qd(8AM) after operation', 'armGroupLabels': ['eso lmwh1', 'lung lmwh1']}, {'name': 'Nadroparin Calcium', 'type': 'DRUG', 'otherNames': ['Fraxiparine'], 'description': '4100AxaIU IH q12h(8Am,8Pm) after operation', 'armGroupLabels': ['eso lmwh2', 'lung lmwh2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'country': 'China', 'facility': 'Zhongshan Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Lizhen Xuan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai Zhongshan Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Zhongshan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'department of anesthesiology and surgical intensive care unit', 'investigatorFullName': 'Ming Zhong', 'investigatorAffiliation': 'Shanghai Zhongshan Hospital'}}}}