Ignite Creation Date:
2025-12-24 @ 11:07 PM
Ignite Modification Date:
2026-02-23 @ 9:01 PM
Study NCT ID:
NCT02320669
Status:
COMPLETED
Last Update Posted:
2024-04-09
First Post:
2014-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phase 3 Triiodothyronine Supplementation for Infants After Cardiopulmonary Bypass
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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': 'D014284', 'term': 'Triiodothyronine'}], 'ancestors': [{'id': 'D013970', 'term': 'Thyronines'}, {'id': 'D013963', 'term': 'Thyroid Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D013974', 'term': 'Thyroxine'}, {'id': 'D024322', 'term': 'Amino Acids, Aromatic'}, {'id': 'D000598', 'term': 'Amino Acids, Cyclic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'michael.portman@seattlechildrens.org', 'phone': '206-987-1014', 'title': 'Michael A Portman', 'organization': 'Seattle Childrens hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '30 days after receiving study medication', 'description': 'Definitions were adopted from Pediatric Heart Network criteria', 'eventGroups': [{'id': 'EG000', 'title': 'Triostat', 'description': 'Active Medication - Synthetic Thyroid Hormone\n\nTriostat: Bolus of Triiodothyronine followed by infusion for 48 hours', 'otherNumAtRisk': 110, 'deathsNumAtRisk': 110, 'otherNumAffected': 17, 'seriousNumAtRisk': 110, 'deathsNumAffected': 6, 'seriousNumAffected': 11}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo Control\n\nPlacebo: Bolus of Placebo followed by infusion for 48 hours', 'otherNumAtRisk': 110, 'deathsNumAtRisk': 110, 'otherNumAffected': 20, 'seriousNumAtRisk': 110, 'deathsNumAffected': 3, 'seriousNumAffected': 11}], 'otherEvents': [{'term': 'Cardiac Arrhythmia', 'notes': 'Postoperative arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 110, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 110, 'numAffected': 20}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}], 'seriousEvents': [{'term': 'Sentinel', 'notes': 'Sentinel including cardiac arrest and ECMO', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time To Extubation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Triostat', 'description': 'Active Medication - Synthetic Thyroid Hormone\n\nTriostat: Bolus of Triiodothyronine followed by infusion for 48 hours'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo Control\n\nPlacebo: Bolus of Placebo followed by infusion for 48 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '46.9', 'groupId': 'OG000', 'lowerLimit': '25.9', 'upperLimit': '71.6'}, {'value': '48.0', 'groupId': 'OG001', 'lowerLimit': '31.0', 'upperLimit': '65.4'}]}]}], 'analyses': [{'pValue': '<.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.083', 'ciLowerLimit': '.82', 'ciUpperLimit': '1.432', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '30 days', 'description': 'time on mechanical ventilation after aortic cross clamp removal', 'unitOfMeasure': 'hours', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'modified intention to treat'}, {'type': 'SECONDARY', 'title': 'ICU Length of Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Triiodothyronine', 'description': 'treatment group'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo group'}], 'classes': [{'categories': [{'measurements': [{'value': '3.5', 'groupId': 'OG000', 'lowerLimit': '2.3', 'upperLimit': '4.8'}, {'value': '2.9', 'groupId': 'OG001', 'lowerLimit': '2.4', 'upperLimit': '3.8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '30 days', 'description': 'Length of stay in the ICU', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Children under age 5 mos undergoing cardiopulmonary bypass'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Triiodothyronine', 'description': 'Active Medication - Synthetic Thyroid Hormone Triostat: Bolus of Triiodothyronine followed by infusion for 48 hours'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo Control Placebo: Bolus of Placebo followed by infusion for 48 hours'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '110'}, {'groupId': 'FG001', 'numSubjects': '110'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '104'}, {'groupId': 'FG001', 'numSubjects': '107'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'BG000'}, {'value': '110', 'groupId': 'BG001'}, {'value': '220', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Triostat', 'description': 'Active Medication - Synthetic Thyroid Hormone\n\nTriostat: Bolus of Triiodothyronine followed by infusion for 48 hours'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo Control\n\nPlacebo: Bolus of Placebo followed by infusion for 48 hours'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '110', 'groupId': 'BG000'}, {'value': '110', 'groupId': 'BG001'}, {'value': '220', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '1.4', 'groupId': 'BG000', 'lowerLimit': '.2', 'upperLimit': '3.6'}, {'value': '1.4', 'groupId': 'BG001', 'lowerLimit': '0.2', 'upperLimit': '3.6'}, {'value': '1.4', 'groupId': 'BG002', 'lowerLimit': '0.2', 'upperLimit': '3.6'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'months', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '136', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '110', 'groupId': 'BG000'}, {'value': '110', 'groupId': 'BG001'}, {'value': '220', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-09-30', 'size': 606246, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-02-17T12:30', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 220}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2019-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-11', 'studyFirstSubmitDate': '2014-12-05', 'resultsFirstSubmitDate': '2023-02-17', 'studyFirstSubmitQcDate': '2014-12-15', 'lastUpdatePostDateStruct': {'date': '2024-04-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-03-11', 'studyFirstPostDateStruct': {'date': '2014-12-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time To Extubation', 'timeFrame': '30 days', 'description': 'time on mechanical ventilation after aortic cross clamp removal'}], 'secondaryOutcomes': [{'measure': 'ICU Length of Stay', 'timeFrame': '30 days', 'description': 'Length of stay in the ICU'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Congenital Heart Defects']}, 'referencesModule': {'references': [{'pmid': '35093535', 'type': 'RESULT', 'citation': 'Portman MA, Slee AE, Roth SJ, Radman M, Olson AK, Mainwaring RD, Kamerkar A, Nuri M, Hastings L; TRICC Investigators. Triiodothyronine Supplementation in Infants Undergoing Cardiopulmonary Bypass: A Randomized Controlled Trial. Semin Thorac Cardiovasc Surg. 2023 Spring;35(1):105-112. doi: 10.1053/j.semtcvs.2022.01.005. Epub 2022 Jan 31.'}]}, 'descriptionModule': {'briefSummary': 'This is a study to determine the safety and efficacy of liothyronine sodium/triiodothyronine (Triostat), a synthetic thyroid hormone, when given to infants with congenital heart disease during cardiopulmonary bypass surgery. Funding Source - FDA OOPD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Informed consent obtained\n2. Male and female patients \\<5 months (152 days) of age\n3. Patients undergoing cardiopulmonary bypass\n\nExclusion Criteria:\n\n1. Known thyroid disease (Down Syndrome is not an exclusion criterion unless patient has thyroid disease)\n2. Trisomy 13 and 18\n3. Prolonged preoperative ventilator support which would not be impacted by cardiac surgery (Lung disease: bronchopulmonary dysplasia, hypoplastic lungs associated with diaphragmatic hernia)\n4. Any other condition as determined by the PI causing prolonged ventilator support which is unlikely to respond favorably to cardiac surgery\n5. Prior participation in the clinical trial'}, 'identificationModule': {'nctId': 'NCT02320669', 'acronym': 'TRICC-2', 'briefTitle': 'Phase 3 Triiodothyronine Supplementation for Infants After Cardiopulmonary Bypass', 'organization': {'class': 'OTHER', 'fullName': "Seattle Children's Hospital"}, 'officialTitle': 'Phase 3 Triiodothyronine Supplementation for Infants After Cardiopulmonary Bypass', 'orgStudyIdInfo': {'id': '14798'}, 'secondaryIdInfos': [{'id': 'R01FD004362-01A2', 'link': 'https://reporter.nih.gov/quickSearch/R01FD004362-01A2', 'type': 'FDA'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Triostat', 'description': 'Active Medication - Synthetic Thyroid Hormone', 'interventionNames': ['Drug: Triostat']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo Control', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Triostat', 'type': 'DRUG', 'otherNames': ['triiodothyronine'], 'description': 'Bolus of Triiodothyronine followed by infusion for 48 hours', 'armGroupLabels': ['Triostat']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Bolus of Placebo followed by infusion for 48 hours', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': "Los Angeles Children's Hospital", 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': "Lucille Packard Children's Hospital", 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': "Seattle Children's Hospital", 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Michael Portman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Seattle Children's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Seattle Children's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Michael Portman', 'investigatorAffiliation': "Seattle Children's Hospital"}}}}