Ignite Creation Date:
2025-12-24 @ 11:17 PM
Ignite Modification Date:
2025-12-25 @ 8:56 PM
Study NCT ID:
NCT03491956
Status:
UNKNOWN
Last Update Posted:
2021-03-17
First Post:
2018-04-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Double Filtration Plasmapheresis (DFPP) and Lipid Metabolism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-16', 'studyFirstSubmitDate': '2018-04-02', 'studyFirstSubmitQcDate': '2018-04-02', 'lastUpdatePostDateStruct': {'date': '2021-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'lipid levels', 'timeFrame': '1 year', 'description': 'reduce in lipid levels'}], 'secondaryOutcomes': [{'measure': 'Platelet RNA sequencing', 'timeFrame': '1 year', 'description': 'whether the RNA sequencing of platelet changed ?'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['DFPP and Platelet Function']}, 'referencesModule': {'references': [{'pmid': '34307504', 'type': 'DERIVED', 'citation': 'Zhang XM, Gu YH, Deng H, Xu ZQ, Zhong ZY, Lyu XJ, Jin HM, Yang XH. Plasma Purification Treatment Relieves the Damage of Hyperlipidemia to PBMCs. Front Cardiovasc Med. 2021 Jul 7;8:691336. doi: 10.3389/fcvm.2021.691336. eCollection 2021.'}]}, 'descriptionModule': {'briefSummary': 'Little clinic trials showed that Double Filtration Plasmapheresis (DFPP) could improve lipid metabolism, however, whether DFPP can improve platelet function and recover Endothelial function is unknown. In this study, we try to confirm the hypothesis that DFPP can improve endothelial function in hyperlipidemia patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. hyperlipidemia\n\nExclusion Criteria:\n\n1. Severe liver and kidney dysfunction\n2. Severe cardiopulmonary insufficiency\n3. tumor\n4. pregnancy'}, 'identificationModule': {'nctId': 'NCT03491956', 'briefTitle': 'Double Filtration Plasmapheresis (DFPP) and Lipid Metabolism', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Pudong Hospital'}, 'officialTitle': 'Double Filtration Plasmapheresis (DFPP) Improves Lipid Profile and Platelet Function in Hyperlipidemia Patients', 'orgStudyIdInfo': {'id': 'ShanghaiPudongH2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'DFPP group', 'description': 'self contrast (before and after DFPP)', 'interventionNames': ['Device: DFPP']}], 'interventions': [{'name': 'DFPP', 'type': 'DEVICE', 'description': 'Lipid levels,platelet function，and platelet RNA sequencing in hyperlipidemia patients before and after DFPP', 'armGroupLabels': ['DFPP group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '201399', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Huimin Jin, doctor', 'role': 'CONTACT'}], 'facility': 'Shanghai Pudong Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Huimin Jin, doctor', 'role': 'CONTACT', 'email': 'hmjgli@163.com', 'phone': '13917232915'}], 'overallOfficials': [{'name': 'Bo Yu, doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai Pudong Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Pudong Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jin HM, MD', 'investigatorAffiliation': 'Shanghai Pudong Hospital'}}}}