Ignite Creation Date:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2025-12-31 @ 7:38 PM
Study NCT ID:
NCT01976234
Status:
COMPLETED
Last Update Posted:
2016-02-03
First Post:
2013-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stored RBC Transfusion and Immonomodulation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 181}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-02', 'studyFirstSubmitDate': '2013-09-30', 'studyFirstSubmitQcDate': '2013-10-29', 'lastUpdatePostDateStruct': {'date': '2016-02-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of infections', 'timeFrame': '28 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Infections']}, 'referencesModule': {'references': [{'pmid': '22395349', 'type': 'RESULT', 'citation': 'Juffermans NP, Vlaar AP, Prins DJ, Goslings JC, Binnekade JM. The age of red blood cells is associated with bacterial infections in critically ill trauma patients. Blood Transfus. 2012 Jul;10(3):290-5. doi: 10.2450/2012.0068-11. Epub 2012 Feb 22.'}]}, 'descriptionModule': {'briefSummary': 'Transfusion of RBC is associated with post operative infections. Our hypothesis is that stored blood could be related with increased post operative infection risk. Surgical patients transfused during the operation or immediately after will be included in our study. Patients will receive fresh or old blood during the whole recovery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients transfused during or in 24h after surgical operation\n\nExclusion Criteria:\n\n* Patients transfused during the 30 days before the operation\n* Immunodepressed patients\n* Infections during the 30 days before operations\n* Emergency surgery'}, 'identificationModule': {'nctId': 'NCT01976234', 'briefTitle': 'Stored RBC Transfusion and Immonomodulation', 'organization': {'class': 'OTHER', 'fullName': 'Università degli Studi di Ferrara'}, 'officialTitle': 'Infective Complication After Surgery and Transfusion of Allogenic RBC Fresh or Stored', 'orgStudyIdInfo': {'id': '04121985'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Fresh group', 'description': 'Fresh group will receive RBC stored for less than 14 days', 'interventionNames': ['Other: Fresh RBC']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Old group', 'description': 'Old group will receive RBC stored for 14 days or more', 'interventionNames': ['Other: Old RBC']}], 'interventions': [{'name': 'Fresh RBC', 'type': 'OTHER', 'description': 'Patients will receive fresh blood only', 'armGroupLabels': ['Fresh group']}, {'name': 'Old RBC', 'type': 'OTHER', 'otherNames': ['Patients will receive blood stored for 14 days or more'], 'armGroupLabels': ['Old group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44121', 'city': 'Ferrara', 'state': 'Ferrara', 'country': 'Italy', 'facility': "Sant'Anna Hospital", 'geoPoint': {'lat': 44.83804, 'lon': 11.62057}}], 'overallOfficials': [{'name': 'Savino Spadaro', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Università degli Studi di Ferrara'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Università degli Studi di Ferrara', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Researcher', 'investigatorFullName': 'Savino Spadaro', 'investigatorAffiliation': 'Università degli Studi di Ferrara'}}}}