Ignite Creation Date:
2025-12-25 @ 1:16 AM
Ignite Modification Date:
2026-01-03 @ 8:40 PM
Study NCT ID:
NCT04164693
Status:
COMPLETED
Last Update Posted:
2024-06-24
First Post:
2019-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Short-term Postoperative Anticoagulant Therapy to Prevente Thrombosis in Arterovenous Fistula
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D001164', 'term': 'Arteriovenous Fistula'}], 'ancestors': [{'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001165', 'term': 'Arteriovenous Malformations'}, {'id': 'D054079', 'term': 'Vascular Malformations'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D016157', 'term': 'Vascular Fistula'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D005402', 'term': 'Fistula'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006495', 'term': 'Heparin, Low-Molecular-Weight'}, {'id': 'D014859', 'term': 'Warfarin'}], 'ancestors': [{'id': 'D006493', 'term': 'Heparin'}, {'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D015110', 'term': '4-Hydroxycoumarins'}, {'id': 'D003374', 'term': 'Coumarins'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The enrolled patients will be randomly assigned to either the anticoagulant group or the control group. Patients in the anticoagulant group will receive a low-dose subcutaneous injection of low molecular weight heparin for the prevention of AVF thrombosis, starting 12-24 hours after the surgery. For patients weighing less than 80kg, enoxaparin sodium 4000IU will be administered once daily, while for those weighing over 80kg, enoxaparin sodium 4000IU will be administered every 12 hours. After discharge, these patients will be switched to oral low-dose warfarin for anticoagulation, with a daily dose of 1.25mg (half tablet) on dialysis days and 2.5mg/day on non-dialysis days. Patients with significantly excessive body weight may be considered for a daily dose of 2.5mg, with a total treatment duration of 4 weeks. Patients in the control group will not receive anticoagulants postoperatively, but both groups will routinely receive antiplatelet therapy.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 287}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-21', 'studyFirstSubmitDate': '2019-11-09', 'studyFirstSubmitQcDate': '2019-11-13', 'lastUpdatePostDateStruct': {'date': '2024-06-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood flow of arteriovenous fistula', 'timeFrame': 'up to 12 months', 'description': 'Blood flow of arteriovenous fistula during hemodialysis from 6 months after operation'}, {'measure': 'arteriovenous fistula dysfunction or occlusion', 'timeFrame': 'up to 12 months', 'description': 'The proportion of arteriovenous fistula dysfunction or occlusion'}, {'measure': 'Active bleeding events', 'timeFrame': 'up to 12 months', 'description': 'such as,bleeding of surgical wound, intracranial, digestive tract and urinary tract, ecchymosis and ecchymosis of skin.'}, {'measure': 'arteriovenous fistula dysfunction or occlusion', 'timeFrame': 'up to 12 months', 'description': 'The time of arteriovenous fistula dysfunction or occlusion'}, {'measure': 'AVF Maturation Failure AVF Maturation Failure AVF Maturation Failure AVF Maturation Failure AVF maturation failure', 'timeFrame': 'up to 2 months', 'description': 'AVF maturation failure two months postoperatively'}], 'secondaryOutcomes': [{'measure': 'coagulation index', 'timeFrame': 'up to 12 months', 'description': 'Change of coagulation index'}, {'measure': 'Platelet', 'timeFrame': 'up to 12 months', 'description': 'Changes of platelet indexes'}, {'measure': 'Number of hospitalization', 'timeFrame': 'up to 12 months', 'description': 'Number of hospitalization due to arteriovenous fistula thrombosis.'}, {'measure': 'Death', 'timeFrame': 'up to 12 months', 'description': 'Death from any cause'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['manitenance hemodialysis', 'arteriovenous fistula', 'anticoagulant therapy', 'fistula function', 'bleeding risk'], 'conditions': ['Thrombosis']}, 'descriptionModule': {'briefSummary': 'Many guidelines at home and abroad advocate that arteriovenous fistula should be the first choice of permanent vascular access, but it is easy to form thrombus in a short time after arteriovenous fistula molding, resulting in internal fistula stenosis or occlusion. In this study, the investigators plan to screen the patients with arteriovenous fistula in the blood purification center of our hospital. Through the study design of random grouping and open label, the investigators will discuss the use of low molecular weight heparin or warfarin to prevent thrombosis in a short period of time after arteriovenous fistula operation. According to the research results, the investigators will understand efficacy and safety of short-term postoperative anticoagulant therapy to prevente thrombosis in arterovenous fistula.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* After AVF formation or balloon dilation surgery, there were no significant signs of oozing or bleeding at the surgical incision and operative site observed within 12-24 hours.\n* The patient is willing to accept short-term anticoagulant therapy after the surgery, bear related risks, and sign an informed consent form.\n* The patient is willing to cooperate with this study, undergo data collection related to the research, and relevant clinical examinations.\n\nExclusion Criteria.\n\n* Age \\>80 years;\n* Concurrent hematologic diseases that can affect coagulation function;\n* Concurrent comorbidities that can affect the patient's bleeding or coagulation functions, such as liver cirrhosis;\n* Concurrent active bleeding disorders, such as active gastrointestinal ulcers or active lupus;\n* History of major organ bleeding (e.g., intracranial or gastrointestinal) or surgery within the past six months;\n* Unwillingness to participate in this study."}, 'identificationModule': {'nctId': 'NCT04164693', 'acronym': 'EASOAT', 'briefTitle': 'Efficacy and Safety of Short-term Postoperative Anticoagulant Therapy to Prevente Thrombosis in Arterovenous Fistula', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital of Chongqing Medical University'}, 'officialTitle': 'Efficacy and Safety of Short-term Postoperative Anticoagulant Therapy to Prevente Thrombosis in Arterovenous Fistula', 'orgStudyIdInfo': {'id': 'The First ChongQingMU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'anticoagulant group', 'description': 'Patients in the anticoagulant group received low-dose subcutaneous injection of low molecular weight heparin for prevention of AVF thrombosis, starting 12-24 hours after surgery. For patients weighing less than 80kg, enoxaparin sodium 4000IU was administered once daily, while for those weighing over 80kg, enoxaparin sodium 4000IU was administered every 12 hours. After discharge, these patients were switched to oral low-dose warfarin for anticoagulation, with a daily dose of 1.25mg (half tablet) on dialysis days, and 2.5mg/day on non-dialysis days. Patients with significantly excessive body weight may be considered for a daily dose of 2.5mg, with a total treatment duration of 4 weeks.', 'interventionNames': ['Drug: Low molecular weight heparin']}, {'type': 'OTHER', 'label': 'control group', 'description': 'Patients in the control group did not receive anticoagulants postoperatively, but both groups routinely received antiplatelet therapy.', 'interventionNames': ['Other: non anticoagulant therapy group']}], 'interventions': [{'name': 'Low molecular weight heparin', 'type': 'DRUG', 'otherNames': ['warfarin sodium tablets'], 'description': 'patients began to use low molecular weight heparin or warfarin sodium tablets.', 'armGroupLabels': ['anticoagulant group']}, {'name': 'non anticoagulant therapy group', 'type': 'OTHER', 'description': 'no anticoagulant was used after operation.', 'armGroupLabels': ['control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '400016', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'country': 'China', 'facility': 'The First Affiliated Hospital of Chongqing Medical University', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}], 'overallOfficials': [{'name': 'Hua Gan, Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'First Affiliated Hospital of Chongqing Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'First Affiliated Hospital of Chongqing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Yunfeng Xia', 'investigatorAffiliation': 'First Affiliated Hospital of Chongqing Medical University'}}}}