Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-27 @ 3:55 PM
Study NCT ID:
NCT01211366
Status:
COMPLETED
Last Update Posted:
2012-02-13
First Post:
2010-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Cell Salvage Post-operatively in Infants to Decrease Use of Allogeneic Blood Product Transfusions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 106}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-02-10', 'studyFirstSubmitDate': '2010-09-28', 'studyFirstSubmitQcDate': '2010-09-28', 'lastUpdatePostDateStruct': {'date': '2012-02-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-09-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of volume of allogeneic blood products and crystalloid/colloid infusions between groups', 'timeFrame': '2 years', 'description': 'To compare the volume of allogeneic blood products and crystalloid/colloid infusions between patients randomized to receive washed intra-operative cell salvage vs our current standard for volume replacement for the first 24 hours post-op'}], 'secondaryOutcomes': [{'measure': 'comparison of bleeding, use of coagulant products, and inflammatory markers between groups', 'timeFrame': '2 years', 'description': 'To compare measures of bleeding (MT drainage, Hgb, platelet counts) , the use of coagulant products (FFP, platelets, cryoprecipitate) and inflammatory/immunomodulatory markers \\[C-reactive protein (CRP) and IL-6/IL-10 ratio\\]between patients randomized to receive washed intra-operative cell salvage vs our current standard of care for volume replacement.'}, {'measure': 'comparison of clinical outcomes between groups', 'timeFrame': '2 years', 'description': 'To compare clinical outcome measures (ventilator days, PCICU duration, thrombosis, bacterial infections and mortality) between patients randomized to receive washed intra-operative cell salvage vs our current standard of care for volume replacement.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['cell saver', 'allogeneic RBCs', 'washed cells', 'PRBC transfusion'], 'conditions': ['Transfusion']}, 'descriptionModule': {'briefSummary': 'Transfusion of washed intra-operative cell salvage post-operatively in the PCICU can be performed safely without increased risk of bleeding or release of inflammatory mediators. This will reduce the need for allogeneic blood products as well as crystalloid and colloid infusions and thus decrease the length of ventilation and intensive care duration for these infants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. Weight \\< or = 20Kg;\n* 2\\. Cardiac surgery with CPB at URMC;\n* 3\\. informed consent\n\nExclusion Criteria:\n\n* 1\\. weight \\> 21 Kg;\n* inability to obtain consent;\n* non-English speaking'}, 'identificationModule': {'nctId': 'NCT01211366', 'acronym': 'cell salvage', 'briefTitle': 'Use of Cell Salvage Post-operatively in Infants to Decrease Use of Allogeneic Blood Product Transfusions', 'organization': {'class': 'OTHER', 'fullName': 'University of Rochester'}, 'officialTitle': 'Post-operative Infusion of Intra-operative Cell Salvage Reduces Allogeneic Blood Product Transfusions and Volume Resuscitation in Pediatric Cardiac Surgery and Improves Clinical Outcomes', 'orgStudyIdInfo': {'id': '32600'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional Transfusion', 'description': 'Infants will receive PRBCs, crystalloid, and colloid for hemodynamic instability per the usual routine at the discretion of the attending intensive care physician', 'interventionNames': ['Other: Conventional volume infusion']}, {'type': 'EXPERIMENTAL', 'label': 'Cell Saver', 'description': 'Infants will receive washed cell-saver RBCs for hemodynamic instability in the first 24 hours post-operative period as long as Hgb is \\< 13 gm/dL and cell-saver is available.', 'interventionNames': ['Other: Cell Saver RBCs']}], 'interventions': [{'name': 'Cell Saver RBCs', 'type': 'OTHER', 'description': 'Use of cell saver RBCs to decrease the infusion of allogeneic PRBCs, crystalloid, and colloid in post-operative infants following CPB as needed for hemodynamic instability', 'armGroupLabels': ['Cell Saver']}, {'name': 'Conventional volume infusion', 'type': 'OTHER', 'description': 'Infusion of allogeneic PRBCs, crystalloid, and colloid as needed for hemodynamic instability', 'armGroupLabels': ['Conventional Transfusion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'University of Rochester Medical Center', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Rochester', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Pediatrics', 'investigatorFullName': 'jill cholette', 'investigatorAffiliation': 'University of Rochester'}}}}