Ignite Creation Date:
2025-12-24 @ 4:36 PM
Ignite Modification Date:
2026-01-05 @ 5:36 PM
Study NCT ID:
NCT02473666
Status:
COMPLETED
Last Update Posted:
2020-11-12
First Post:
2015-05-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patient Blood Management - Use and Outcome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006470', 'term': 'Hemorrhage'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 250000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2019-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-10', 'studyFirstSubmitDate': '2015-05-11', 'studyFirstSubmitQcDate': '2015-06-11', 'lastUpdatePostDateStruct': {'date': '2020-11-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-06-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of transfusions per participant', 'timeFrame': 'participants will be followed form date of hospital entry until date of discharge or date of death up to 3 years', 'description': 'Participant wich had transfusion will be identified and the administrative, financial and clinical data will be compared to participants without transfusions'}], 'secondaryOutcomes': [{'measure': 'Percentage of transfusion of any blood product per participant', 'timeFrame': 'participants will be followed form date of hospital entry until date of discharge or date of death up to 3 years', 'description': 'Count of any blood products per case, QM Data'}, {'measure': 'Cost of any blood product per participant', 'timeFrame': 'participants will be followed form date of hospital entry until date of discharge or date of death up to 3 years', 'description': 'costs per case'}, {'measure': 'Survey of Patient Blood Management System', 'timeFrame': 'participants will be followed form date of hospital entry until date of discharge or date of death up to 3 years', 'description': 'clinical, financial,and administrative data of all participants will be reviewed on the focus on transfusions'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Patient Blood Management', 'Red Blood Cells', 'Platelet'], 'conditions': ['Hemorrhage']}, 'descriptionModule': {'briefSummary': 'Study the influence of transfusion related Patient Blood Management Program actions on transfusion-related outcome measures and cost.', 'detailedDescription': 'At the University Hospital of Zurich, an in-house designed monitoring and feedback system was introduced which electronically registers each transfusion of any allogeneic blood product, be it red blood cells, plasma or platelets as well as corresponding laboratory data. Results are reported quarterly to Department heads. The investigator analyzes whether the introduction of this monitoring and feedback system as part of a patient blood management Program has a significant influence on use of allogeneic blood product transfusions and transfusion-related costs, without compromising patient outcome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All cases of all in hospital patients. Area of Focus: Transfusions of blood products.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Only case records, all discharged patients of the University Hospital of Zürich\n\nExclusion Criteria:\n\n* Not discharged from our Hospital.'}, 'identificationModule': {'nctId': 'NCT02473666', 'acronym': 'PBM-USZ', 'briefTitle': 'Patient Blood Management - Use and Outcome', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Patient Blood Management - Use and Outcome', 'orgStudyIdInfo': {'id': 'KEK 2015-0175'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'All Health Conditions.', 'description': 'All Health Conditions. Area of Focus: Transfusions of blood products.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '8091', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'University Hospital Zurich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Donat R Spahn, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IFA University Hospital Zurich'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}