Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2026-01-05 @ 5:25 PM
Study NCT ID:
NCT02149069
Status:
UNKNOWN
Last Update Posted:
2015-08-03
First Post:
2014-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Blood Management Program in the Post - Operative Period.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2016-08-25', 'releaseDate': '2016-07-14'}, {'resetDate': '2016-11-04', 'releaseDate': '2016-09-19'}, {'resetDate': '2018-10-26', 'releaseDate': '2018-02-01'}, {'resetDate': '2025-07-10', 'releaseDate': '2025-06-23'}], 'estimatedResultsFirstSubmitDate': '2016-07-14'}}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2016-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-07-31', 'studyFirstSubmitDate': '2014-05-26', 'studyFirstSubmitQcDate': '2014-05-28', 'lastUpdatePostDateStruct': {'date': '2015-08-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-05-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of therapeutic appropriateness for Red Cells - Plasma - Platelets transfusion: comparison between prospective vs. retrospective data in ASMN ,Reggio Emilia (Italy)', 'timeFrame': '24 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Excessive Amount of Blood / Fluid Transfusion']}, 'descriptionModule': {'briefSummary': 'A care path in the field of transfusion medicine was creates at ASMN - IRCCS addressed to patients undergoing complex surgical procedures.', 'detailedDescription': 'This pathway is called Blood Management Program (BMP).\n\nThe implementation of this process should improve transfusion therapy in the peri-operative period in order to:\n\n* correct the transfusional approach to surgical patients\n* optimize the management of transfusional resources (red blood cells, plasma, platelets)\n* optimize the management of plasma derivatives, drugs and techniques designed to limit the use of homologous blood'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients undergoing complex surgical procedures', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-All patients undergoing complex surgical procedures\n\nExclusion Criteria:'}, 'identificationModule': {'nctId': 'NCT02149069', 'briefTitle': 'Blood Management Program in the Post - Operative Period.', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Azienda USL Reggio Emilia - IRCCS'}, 'officialTitle': 'Blood Management Program: Appropriateness of Transfusion Therapy in the Post - Operative Period.', 'orgStudyIdInfo': {'id': 'BMP - TRASFU1'}}, 'contactsLocationsModule': {'locations': [{'zip': '42123', 'city': 'Reggio Emilia', 'state': 'Emilia-Romagna', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Pamela Berni, Biology', 'role': 'CONTACT', 'email': 'pamela.berni@asmn.re.it', 'phone': '+39-0522-295057'}, {'name': 'Di Bartolomeo Erminia, Physician', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'IRCCS-Arcispedale Santa Maria Nuova', 'geoPoint': {'lat': 44.69825, 'lon': 10.63125}}], 'centralContacts': [{'name': 'Berni Pamela, Doctor', 'role': 'CONTACT', 'email': 'pamela.berni@asmn.re.it', 'phone': '0039-0522-295601'}], 'overallOfficials': [{'name': 'Erminia Di Bartolomeo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ASMN-IRCCS'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda USL Reggio Emilia - IRCCS', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Data Manager', 'investigatorFullName': 'PAMELABERNI', 'investigatorAffiliation': 'Azienda USL Reggio Emilia - IRCCS'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2016-07-14', 'type': 'RELEASE'}, {'date': '2016-08-25', 'type': 'RESET'}, {'date': '2016-09-19', 'type': 'RELEASE'}, {'date': '2016-11-04', 'type': 'RESET'}, {'date': '2018-02-01', 'type': 'RELEASE'}, {'date': '2018-10-26', 'type': 'RESET'}, {'date': '2025-06-23', 'type': 'RELEASE'}, {'date': '2025-07-10', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Azienda USL Reggio Emilia - IRCCS'}}}}