Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2026-02-25 @ 10:04 PM
Study NCT ID:
NCT02485366
Status:
WITHDRAWN
Last Update Posted:
2020-04-27
First Post:
2015-06-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rejuvenated, Washed Packed Red Blood Cells in Pediatric Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006330', 'term': 'Heart Defects, Congenital'}], 'ancestors': [{'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, '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': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Product unavailability', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2020-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2021-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-04-23', 'studyFirstSubmitDate': '2015-06-26', 'studyFirstSubmitQcDate': '2015-06-26', 'lastUpdatePostDateStruct': {'date': '2020-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-06-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in tissue oxygenation/perfusion during cardiac surgery, measured by whole blood lactate concentration', 'timeFrame': 'End of Surgery'}, {'measure': 'Change in ischemic organ injury during cardiac surgery, measured by urinary neutrophil gelatinase associated lipocalin (NGAL)', 'timeFrame': '2 hours'}, {'measure': 'Change in hemolysis during cardiac surgery, as measured by plasma free hemoglobin levels', 'timeFrame': 'end of bypass'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Rejuvenated packed red blood cells'], 'conditions': ['Heart Defects, Congenital']}, 'descriptionModule': {'briefSummary': 'Blood transfusion is nearly always needed during open heart surgery in children less than 15 kg (35 pounds). The purpose of the red blood cells in the blood is to deliver oxygen to the organs and tissues of the body. Stored blood undergoes some changes that may make it less effective in achieving this goal. The purpose of this study is to see if restoring important energy molecules (ATP and 2,3,DPG) in stored red blood cells before they are transfused, with a rejuvenating solution (Rejuvesol), offers any advantages to children over standard blood transfusion. This is a Food and Drug Administration (FDA) approved process that is described by the American Association of Blood Banks for prolonging blood storage but not used for everyday transfusions. The investigators want to use this process to improve blood transfused to children undergoing heart surgery.\n\nAlthough Rejuvesol has been previously approved by the FDA, it is not routinely used to prepare standard blood transfusions to children undergoing surgery. Use of Rejuvesol in this study is considered investigational. This is a pilot study and data will be collected for future protocol development.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* children greater than 2.5 kg and less than 15kg (i.e. requiring blood for CPB prime)\n* children undergoing cardiac surgery with cardiopulmonary bypass\n\nExclusion Criteria:\n\n* refusal of blood products\n* end-stage renal disease\n* planned avoidance of CPB\n* use of non- heparin anticoagulants\n* participation in an experimental drug or device protocol within 30 days\n* existing hemoglobinopathy\n* allergy requiring washed RBCs\n* immunocompromise requiring special blood product treatment.'}, 'identificationModule': {'nctId': 'NCT02485366', 'briefTitle': 'Rejuvenated, Washed Packed Red Blood Cells in Pediatric Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Rejuvenated, Washed Packed Red Blood Cells in Pediatric Cardiac Surgery', 'orgStudyIdInfo': {'id': 'Pro00021487'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rejuvenated PRBCs', 'description': 'The investigators will restore important energy molecules in stored red blood cells before they are transfused, with a rejuvenating solution (Rejuvesol).', 'interventionNames': ['Drug: Rejuvesol', 'Procedure: Cardiac surgery']}], 'interventions': [{'name': 'Rejuvesol', 'type': 'DRUG', 'description': 'Blood transfused during surgery will be treated with Rejuvesol.', 'armGroupLabels': ['Rejuvenated PRBCs']}, {'name': 'Cardiac surgery', 'type': 'PROCEDURE', 'description': 'The study interventions will take place during a routine admission for pediatric open heart surgery. The anesthetic technique for subjects undergoing cardiac surgery is standard care and the research study interventions will not change these practices in any way.', 'armGroupLabels': ['Rejuvenated PRBCs']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke Univerisity Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Andrew Lodge, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}