Ignite Creation Date:
2025-12-24 @ 10:13 PM
Ignite Modification Date:
2026-02-23 @ 9:37 AM
Study NCT ID:
NCT02423135
Status:
COMPLETED
Last Update Posted:
2015-04-22
First Post:
2014-10-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Detection of Autologous DEHP (DiEthylHexyl Phthalate)-Free Blood Transfusion in Anti-doping
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'releaseDate': '2015-09-23', 'unreleaseDateUnknown': True}, {'resetDate': '2015-10-28', 'releaseDate': '2015-09-28'}], 'estimatedResultsFirstSubmitDate': '2015-09-23'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D065227', 'term': 'Transfusion Reaction'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001804', 'term': 'Blood Transfusion, Autologous'}], 'ancestors': [{'id': 'D001803', 'term': 'Blood Transfusion'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-17', 'studyFirstSubmitDate': '2014-10-13', 'studyFirstSubmitQcDate': '2015-04-17', 'lastUpdatePostDateStruct': {'date': '2015-04-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-04-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurement of blood parameters profile, iron metabolism and genomic compounds', 'timeFrame': '1 month', 'description': 'Blood profiling such as measurement of concentration of different blood cells and hemoglobin will be measured up to 15 days after blood-reinfusion. Concentration of free-iron, ferritin and hepcidin will be measured in plasma and serum up to 15 days after blood re-infusion.\n\nConcentration of circulating microRNAs will be measured in plasma also up to 15 days after blood re-infusion. All measures are compared.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Transfusion Reaction']}, 'referencesModule': {'references': [{'pmid': '26822428', 'type': 'DERIVED', 'citation': 'Leuenberger N, Barras L, Nicoli R, Robinson N, Baume N, Lion N, Barelli S, Tissot JD, Saugy M. Hepcidin as a new biomarker for detecting autologous blood transfusion. Am J Hematol. 2016 May;91(5):467-72. doi: 10.1002/ajh.24313. Epub 2016 Apr 6.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the proposed project is to perform a clinical study in which volunteers will receive autologous blood transfusions in DEHP-free blood bags.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have to fill the swiss blood donation formulary\n\nExclusion Criteria:\n\n* Anemia\n* Cardiovascular disease\n* Neurologic disease\n* Not performed a blood donation for 5 weeks ago the start of the study.\n* Immunological disease'}, 'identificationModule': {'nctId': 'NCT02423135', 'briefTitle': 'Detection of Autologous DEHP (DiEthylHexyl Phthalate)-Free Blood Transfusion in Anti-doping', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Vaudois'}, 'officialTitle': 'Detection of Autologous DEHP (DiEthylHexyl Phthalate)-Free Blood Transfusion Using a Combination of Multiple Biomarkers in Different Matrices.', 'orgStudyIdInfo': {'id': 'Protocol 06/14'}, 'secondaryIdInfos': [{'id': '12C14NL', 'type': 'OTHER_GRANT', 'domain': 'World Anti-doping Agency'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Blood bags without DEHP', 'description': 'Intervention : Autologous blood transfusion', 'interventionNames': ['Biological: Autologous blood transfusion']}, {'type': 'EXPERIMENTAL', 'label': 'Blood bags with DEHP', 'description': 'Intervention : Autologous blood transfusion', 'interventionNames': ['Biological: Autologous blood transfusion']}], 'interventions': [{'name': 'Autologous blood transfusion', 'type': 'BIOLOGICAL', 'description': 'Volunteers make a blood donation and after 36 days of storage this blood is re-infused in the same volunteers.', 'armGroupLabels': ['Blood bags with DEHP', 'Blood bags without DEHP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1066', 'city': 'Épalinges', 'state': 'Canton of Vaud', 'country': 'Switzerland', 'facility': 'Swiss Laboratory for Doping Analyses', 'geoPoint': {'lat': 46.54896, 'lon': 6.66831}}], 'overallOfficials': [{'name': 'Nicolas Leuenberger, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Swiss Laboratory for Doping Analyses'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Vaudois', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr, PhD', 'investigatorFullName': 'Nicolas Leuenberger', 'investigatorAffiliation': 'Centre Hospitalier Universitaire Vaudois'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2015-09-23', 'type': 'RELEASE'}, {'type': 'UNRELEASE', 'dateUnknown': True}, {'date': '2015-09-28', 'type': 'RELEASE'}, {'date': '2015-10-28', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Nicolas Leuenberger, Dr, PhD, Centre Hospitalier Universitaire Vaudois'}}}}