Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2026-01-05 @ 2:47 PM
Study NCT ID:
NCT04925167
Status:
COMPLETED
Last Update Posted:
2024-03-26
First Post:
2021-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Argatroban Applicated in Anticoagulation of V-V ECMO
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012131', 'term': 'Respiratory Insufficiency'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C031942', 'term': 'argatroban'}, {'id': 'D006493', 'term': 'Heparin'}], 'ancestors': [{'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-24', 'studyFirstSubmitDate': '2021-06-11', 'studyFirstSubmitQcDate': '2021-06-11', 'lastUpdatePostDateStruct': {'date': '2024-03-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'incidence of ECMO related thrombotic events', 'timeFrame': '14 days', 'description': 'the incidence of ECMO related thrombotic events, such as membrane oxygenator or tube thrombosis.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Respiratory Failure']}, 'descriptionModule': {'briefSummary': 'Unfractionated heparin is most common in the anticoagulation management of V-V ECMO. However, many side effects of unfractionated heparin, such as HIT, antithrombin deficiency, etc seriously affects the prognosis of patients. Argatroban is kind of direct thrombin inhibitors, which could be used used as an alternative anticoagulant of unfractionated heparin when HIT or antithrombin deficiency, etc. At present, there is no power enough evidence for the application of argatroban in V-V ECMO. This study aims to evaluat the safety and effectiveness of argatroban in the anticoagulation management of V-V ECMO compared with unfractionated heparin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age older than 18 years old; received V-V ECMO because of sevever respiratory failure\n\nExclusion Criteria:\n\n* anticoagulant contraindications; Confirmed or suspected, or previously diagnosed with heparin induced thrombocytopenia; Cerebral infarction or suspected patients; Patients with severe liver dysfunction; Allergic to heparin or argatroban; hemophilia; Unwilling or unable to complete the study.'}, 'identificationModule': {'nctId': 'NCT04925167', 'briefTitle': 'Safety and Efficacy of Argatroban Applicated in Anticoagulation of V-V ECMO', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Chao Yang Hospital'}, 'officialTitle': 'Safety and Efficacy of Argatroban Applicated in Anticoagulation of V-V ECMO: A Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'Argatroban in V-V ECMO'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'argatroban group', 'description': 'Patients received argatroban for anticoagulation during V-V ECMO.', 'interventionNames': ['Drug: Argatroban']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'UFH group', 'description': 'Patients received UFH for anticoagulation during V-V ECMO.', 'interventionNames': ['Drug: unfractionated heparin']}], 'interventions': [{'name': 'Argatroban', 'type': 'DRUG', 'otherNames': ['Novastan'], 'description': 'Argatroban continuous intravenous injection maintained APTT at 1.5 times of baseline.', 'armGroupLabels': ['argatroban group']}, {'name': 'unfractionated heparin', 'type': 'DRUG', 'description': 'unfractionated heparin continuous intravenous injection maintained APTT at 1.5 times of baseline.', 'armGroupLabels': ['UFH group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100020', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Bing Sun', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Bing Sun, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing Chao Yang Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': '1 year after the study completed.', 'ipdSharing': 'YES', 'description': 'Study protocal, statistical analysis plan, informed consent form and clinical study report will be shared.', 'accessCriteria': 'Contact PI by email with reasonable reasons.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Chao Yang Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Bing Sun', 'investigatorAffiliation': 'Beijing Chao Yang Hospital'}}}}