Ignite Creation Date:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2025-12-26 @ 3:15 AM
Study NCT ID:
NCT02575820
Status:
WITHDRAWN
Last Update Posted:
2016-05-13
First Post:
2015-10-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Old Blood and Postoperative Complications
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011183', 'term': 'Postoperative Complications'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Sample size was too small to evaluate the clinical implications.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2015-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-12', 'studyFirstSubmitDate': '2015-10-11', 'studyFirstSubmitQcDate': '2015-10-14', 'lastUpdatePostDateStruct': {'date': '2016-05-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-10-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality', 'timeFrame': 'postoperative 7 days'}, {'measure': 'Sepsis', 'timeFrame': 'postoperative 7 days'}, {'measure': 'Wound infection', 'timeFrame': 'postoperative 7 days'}, {'measure': 'Postoperative delirium', 'timeFrame': 'postoperative 7 days'}, {'measure': 'Postoperative bleeding', 'timeFrame': 'postoperative 7 days'}], 'secondaryOutcomes': [{'measure': 'Transfusion related lung injury', 'timeFrame': 'postoperative 7 days'}, {'measure': 'Pulmonary edema', 'timeFrame': 'postoperative 7 days'}, {'measure': 'Pulmonary effusion', 'timeFrame': 'postoperative 7 days'}, {'measure': 'Myocardial ischemia', 'timeFrame': 'postoperative 7 days'}, {'measure': 'Pulmonary thromboembolism', 'timeFrame': 'postoperative 7 days'}, {'measure': 'Renal failure', 'timeFrame': 'postoperative 7 days'}, {'measure': 'Hepatic failure', 'timeFrame': 'postoperative 7 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Orthopedics', 'Postoperative Complications', 'Red Blood Cells']}, 'descriptionModule': {'briefSummary': "The investigators sought to examine the effects of 'old' red blood cells on mortality and morbidity of patients who undergoing revision hip replacement arthroplasty. The investigators hypothesis is that patients have an increased risk of mortality and infection after 'old' red blood cells transfusions compared with those who received 'new' transfusions."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who underwent revision total hip replacement', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who underwent revision total hip replacement\n\nExclusion Criteria:\n\n* Patients who were not given red blood cells\n* Patients who were given two units of which one unit was old and one was new'}, 'identificationModule': {'nctId': 'NCT02575820', 'briefTitle': 'Old Blood and Postoperative Complications', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'The Effects of Old Red Blood Cell Transfusion on Morbidity in Patients Undergoing Revision Total Hip Arthroplasty: Retrospective Study', 'orgStudyIdInfo': {'id': 'B-1510/318-112'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'RBC_old', 'description': 'shelf life of red blood cells of 15 or higher days', 'interventionNames': ['Procedure: Old red blood cells transfusion']}, {'label': 'RBC_new', 'description': 'shelf life of red blood cells 14 or lower days', 'interventionNames': ['Procedure: New red blood cells transfusion']}], 'interventions': [{'name': 'Old red blood cells transfusion', 'type': 'PROCEDURE', 'description': 'Red blood cells (shelf life \\> 14 days) transfusion during the operation (total hip replacement arthroplasty)', 'armGroupLabels': ['RBC_old']}, {'name': 'New red blood cells transfusion', 'type': 'PROCEDURE', 'description': 'Red blood cells (shelf life =\\< 14 days) transfusion during the operation (total hip replacement arthroplasty)', 'armGroupLabels': ['RBC_new']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13620', 'city': 'Seongnam-si', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Hyun-Jung Shin', 'investigatorAffiliation': 'Seoul National University Bundang Hospital'}}}}