Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2026-02-18 @ 1:38 AM
Study NCT ID:
NCT04261205
Status:
COMPLETED
Last Update Posted:
2020-11-16
First Post:
2019-11-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Efficacy and Tolerance of Plasmapheresis by Double Cascade Filtration in a University Centre
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051437', 'term': 'Renal Insufficiency'}], 'ancestors': [{'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2020-11-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-13', 'studyFirstSubmitDate': '2019-11-27', 'studyFirstSubmitQcDate': '2020-02-05', 'lastUpdatePostDateStruct': {'date': '2020-11-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Apheresis by DFPP and biological efficiency', 'timeFrame': 'over a period of one year', 'description': 'quantification of the purification carried out (volume)'}], 'secondaryOutcomes': [{'measure': 'Clinical side effects', 'timeFrame': 'within 1 hour of all session', 'description': 'catheter dysfunction'}, {'measure': 'Biological side effects', 'timeFrame': 'within 1 hour of all session', 'description': 'Bleeding rate'}, {'measure': 'variation of Hb, platelet and albumin before and after session', 'timeFrame': 'within 1 hour of all session', 'description': '% of Hb, platelet and albumin'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic hemodialysis'], 'conditions': ['Kidney Failure']}, 'descriptionModule': {'briefSummary': 'A study is being carried out to evaluate the biological, technical and clinical/biological efficacy of this technique, the practice of which is standardized in the department, in order to evaluate our practices and to improve them if necessary. As part of this study, the investigators will ask all patients scheduled for this procedure to participate in this observational prospective study without changing usual practices.', 'detailedDescription': 'The objective of the study is to conduct a prospective evaluation of the practice of apheresis by Double Filtration System Cascade system in a university centre in current practice with evaluation of the technical and biological effectiveness as the main objective and clinical and biological tolerance as the secondary objective for all consecutive sessions performed in a university centre over a period of 1 year.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients over 18 years of age who consecutively benefit from plasmapheresis sessions by double cascade filtration system during hospitalization at the University Hospital of Nîmes, within the framework of the usual indications retained in the department for a period of 12 months.', 'eligibilityCriteria': 'Inclusion Criteria:\n\nOver 18 years of age I indication for plasmapheresis and hospitalized at Chu de Nimes.\n\nExclusion Criteria:\n\nUnder guardianship or curatorship Refusal to participate'}, 'identificationModule': {'nctId': 'NCT04261205', 'acronym': 'DFPPSURV', 'briefTitle': 'Evaluation of the Efficacy and Tolerance of Plasmapheresis by Double Cascade Filtration in a University Centre', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nīmes'}, 'officialTitle': 'Evaluation of the Efficacy and Tolerance of Plasmapheresis by Double Cascade Filtration in a University Centre', 'orgStudyIdInfo': {'id': 'Local/2017/0M-01'}}, 'contactsLocationsModule': {'locations': [{'zip': '30029', 'city': 'Nîmes', 'country': 'France', 'facility': 'CHU de Nîmes, Hôpital Universitaire Caremeau', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}], 'overallOfficials': [{'name': 'Olivier Moranne, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Nîmes'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nīmes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}