Ignite Creation Date:
2025-12-26 @ 11:08 AM
Ignite Modification Date:
2025-12-29 @ 8:14 AM
Study NCT ID:
NCT03346512
Status:
COMPLETED
Last Update Posted:
2019-04-19
First Post:
2017-11-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Considerations on the Transfusion Threshold in Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D006348', 'term': 'Cardiac Surgical Procedures'}], 'ancestors': [{'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019616', 'term': 'Thoracic Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 852}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2016-06-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-18', 'studyFirstSubmitDate': '2017-11-15', 'studyFirstSubmitQcDate': '2017-11-15', 'lastUpdatePostDateStruct': {'date': '2019-04-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-06-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hemoglobin rate', 'timeFrame': 'Baseline (just before cardiac surgery)', 'description': 'Hemoglobin rate'}, {'measure': 'Hemoglobin rate', 'timeFrame': 'One day after surgery (J1)', 'description': 'Hemoglobin rate'}, {'measure': 'Hemoglobin rate', 'timeFrame': 'Two days after surgery (J2)', 'description': 'Hemoglobin rate'}, {'measure': 'Hemoglobin rate', 'timeFrame': 'Five days after surgery (J5)', 'description': 'Hemoglobin rate'}, {'measure': 'Hematocrit rate', 'timeFrame': 'Baseline (just before cardiac surgery)', 'description': 'Hematocrit rate'}, {'measure': 'Hematocrit rate', 'timeFrame': 'One day after surgery (J1)', 'description': 'Hematocrit rate'}, {'measure': 'Hematocrit rate', 'timeFrame': 'Two days after surgery (J2)', 'description': 'Hematocrit rate'}, {'measure': 'Hematocrit rate', 'timeFrame': 'Five days after surgery (J5)', 'description': 'Hematocrit rate'}, {'measure': 'International Normalized Ratio (INR)', 'timeFrame': 'Baseline (just before cardiac surgery)', 'description': 'Coagulation indicator'}, {'measure': 'International Normalized Ratio (INR)', 'timeFrame': 'One day after surgery (J1)', 'description': 'Coagulation indicator'}, {'measure': 'International Normalized Ratio (INR)', 'timeFrame': 'Two days after surgery (J2)', 'description': 'Coagulation indicator'}, {'measure': 'International Normalized Ratio (INR)', 'timeFrame': 'Five days after surgery (J5)', 'description': 'Coagulation indicator'}, {'measure': 'Creatinin rate', 'timeFrame': 'Baseline (just before cardiac surgery)', 'description': 'Renal function indicator'}, {'measure': 'Creatinin rate', 'timeFrame': 'One day after surgery (J1)', 'description': 'Renal function indicator'}, {'measure': 'Creatinin rate', 'timeFrame': 'Two days after surgery (J2)', 'description': 'Renal function indicator'}, {'measure': 'Creatinin rate', 'timeFrame': 'Five days after surgery (J5)', 'description': 'Renal function indicator'}, {'measure': 'Total amount of blood perfusions', 'timeFrame': 'Five days after surgery (J5)', 'description': 'Total amount of blood perfusions'}, {'measure': 'Liquid balance', 'timeFrame': 'One day after surgery', 'description': 'Ratio between total fluid intake (perfusion) and loss (blood and urine)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiac Surgery']}, 'descriptionModule': {'briefSummary': 'This is a retrospective observational study of the transfusion threshold in cardiac surgery.\n\nThere is controversy in the literature regarding the transfusion threshold to be adopted, especially in a patient who has undergone cardiac surgery. Some authors suggest that the transfusion should be done in a restrictive way when a certain threshold in hemoglobin is reached, in order to avoid the risks it implies, especially infectious.This threshold is very controversial and remains to be defined (variations in the literature from 7g / dL to 9g / dL). Other authors conclude that there is no superiority of a restrictive transfusion compared to a more liberal transfusion, with regard to the morbidity or medical costs.\n\nIt is therefore interesting to study, in a retrospective manner, the global and multidisciplinary management of patients who have undergone a cardiac surgery within the CHU Brugmann hospital, to analyze if they have been adequately transfused.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients having undergone cardiac surgery (other than the placement of a pacemaker or defibrillator) within the CHU Brugmann hospital between 2006 and 2015', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Patients having undergone cardiac surgery (other than the placement of a pacemaker or defibrillator) within the CHU Brugmann hospital between 2006 and 2015\n\nExclusion Criteria:\n\n* N/A'}, 'identificationModule': {'nctId': 'NCT03346512', 'briefTitle': 'Considerations on the Transfusion Threshold in Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Brugmann University Hospital'}, 'officialTitle': 'Considerations on the Transfusion Threshold in Cardiac Surgery', 'orgStudyIdInfo': {'id': 'CHUB-perfusion'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cardiac surgery', 'description': 'Patients having undergone cardiac surgery (other than the placement of a pacemaker or defibrillator) within the CHU Brugmann hospital between 2006 and 2015', 'interventionNames': ['Procedure: Cardiac surgery']}], 'interventions': [{'name': 'Cardiac surgery', 'type': 'PROCEDURE', 'description': 'Cardiac surgery', 'armGroupLabels': ['Cardiac surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1020', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'CHU Brugmann', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'overallOfficials': [{'name': 'Kenza Bradly, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Brugmann'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pierre Wauthy', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Head of clinic', 'investigatorFullName': 'Pierre Wauthy', 'investigatorAffiliation': 'Brugmann University Hospital'}}}}