Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2026-02-28 @ 6:47 PM
Study NCT ID:
NCT02852993
Status:
COMPLETED
Last Update Posted:
2016-08-02
First Post:
2016-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Survival After Blood Transfusion in the French Administrative Regions of Burgundy and Franche-Comté
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16099}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-01', 'studyFirstSubmitDate': '2016-07-29', 'studyFirstSubmitQcDate': '2016-08-01', 'lastUpdatePostDateStruct': {'date': '2016-08-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-08-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survival', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Erythrocyte Transfusion', 'Survival'], 'conditions': ['Erythrocyte Transfusion for All Conditions']}, 'referencesModule': {'references': [{'pmid': '26935140', 'type': 'RESULT', 'citation': 'Desmarets M, Bardiaux L, Benzenine E, Dussaucy A, Binda D, Tiberghien P, Quantin C, Monnet E. Effect of storage time and donor sex of transfused red blood cells on 1-year survival in patients undergoing cardiac surgery: an observational study. Transfusion. 2016 May;56(5):1213-22. doi: 10.1111/trf.13537. Epub 2016 Mar 2.'}]}, 'descriptionModule': {'briefSummary': 'Red blood cell transfusion (RBC) is the main symptomatic treatment for severe anemia. RBC transfusion has proven its efficacy regarding mortality and morbidity, but it is not without side effects. The infectious side effects of transfusion are largely considered under control, non-infectious side effects are taking center stage. Seeking explanations for the beneficial and deleterious effects of RBC transfusions is necessary to ensure the safe and optimal use of this precious resource.\n\nThe investigators aim to study the impact of donor and RBC characteristics on patient survival.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The eligible patients consisted of all adult patients transfused for the first time (defined as patients with no known history of RBC unit use in the transfusion register), at the university hospitals of Besançon or Dijon, between January 2007 and December 2011.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18 and over\n* Erythrocyte Transfusion between 2007 and 2011\n* Performed at the University Hospital of Besançon or Dijon\n\nExclusion Criteria:\n\n* Transfusion of any blood product prior to January 1st, 2007'}, 'identificationModule': {'nctId': 'NCT02852993', 'acronym': 'STeF-BFC', 'briefTitle': 'Survival After Blood Transfusion in the French Administrative Regions of Burgundy and Franche-Comté', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Besancon'}, 'officialTitle': 'Survival After Blood Transfusion in the French Administrative Regions of Burgundy and Franche-Comté', 'orgStudyIdInfo': {'id': 'P/2013/176'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Transfused patients', 'description': 'A cohort of patients receiving erythrocyte transfusion for the first time at the CHU Besançon or CHU Dijon during the study period.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '25030', 'city': 'Besançon', 'country': 'France', 'facility': "Centre d'Investigation Clinique, CHU de Besançon", 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'zip': '21079', 'city': 'Dijon', 'country': 'France', 'facility': "Département d'information Médicale, CHU Dijon", 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}], 'overallOfficials': [{'name': 'Maxime Desmarets, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Centre d'Investigation Clinique; CHU Besançon"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Besancon', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centre Hospitalier Universitaire Dijon', 'class': 'OTHER'}, {'name': 'Etablissement Français du Sang', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}