Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 10:03 PM
Study NCT ID:
NCT04415658
Status:
COMPLETED
Last Update Posted:
2024-01-10
First Post:
2020-05-27
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Intravenous Thyroxine for Heart-Eligible Organ Donors
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-11-09', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D001926', 'term': 'Brain Death'}, {'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003128', 'term': 'Coma'}, {'id': 'D014474', 'term': 'Unconsciousness'}, {'id': 'D003244', 'term': 'Consciousness Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D003643', 'term': 'Death'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013974', 'term': 'Thyroxine'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D013963', 'term': 'Thyroid Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'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'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dharr@wustl.edu', 'phone': '3143622999', 'title': 'Dr. Rajat Dhar', 'organization': 'Washington University in St. Louis School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Not blinded, open-label use of levothyroxine permitted in control group after 12 hours (only 50 donors in that group received open-label, plus three who crossed-over to levothyroxine immediately after randomization)'}}, 'adverseEventsModule': {'timeFrame': '1 week', 'description': 'Serious adverse event defined as donor instability resulting in cardiac arrest or premature donor loss.\n\nAdverse events were collected for each arm combining all study periods, i.e. from study onset through end of donor management (organ recovery). These were not collected for each period (i.e. first 12 hours versus open-label period) separately.', 'eventGroups': [{'id': 'EG000', 'title': 'Thyroxine', 'description': 'Intravenous thyroxine infusion\n\nThyroxine: Infusion prepared by mixing 500 μg of drug in 500-ml of normal saline (i.e. concentration of 1 μg/ml) and enclosing the bag in an opaque sleeve. Infusion started at 30 μg/hour (30 ml/hour) for twelve hours.\n\nDonors were followed till organ recovery or end of management.', 'otherNumAtRisk': 419, 'deathsNumAtRisk': 419, 'otherNumAffected': 51, 'seriousNumAtRisk': 419, 'deathsNumAffected': 419, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Saline Placebo', 'description': 'Intravenous saline infusion\n\nSaline: The placebo will be a 500-ml bag of normal saline (without active drug) also enclosed in an opaque sleeve. This infusion will also be started at 30 ml/hour for twelve hours.\n\nDonors were followed till organ recovery or end of management.', 'otherNumAtRisk': 419, 'deathsNumAtRisk': 419, 'otherNumAffected': 16, 'seriousNumAtRisk': 419, 'deathsNumAffected': 419, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 419, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 419, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 419, 'numEvents': 26, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 419, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 419, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 419, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ventricular ectopy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 419, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 419, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ventricular tachycardia', 'notes': 'not including unstable/leading to arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 419, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 419, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Misc/Other', 'notes': 'includes rash, electrolyte disturbance, respiratory distress, pulmonary edema, hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 419, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 419, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Cardiac arrest / donor loss', 'notes': 'Hemodynamic instability resulting in cardiac arrest and/or donor loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 419, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 419, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Heart Transplanted', 'denoms': [{'units': 'Participants', 'counts': [{'value': '419', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Thyroxine', 'description': 'Intravenous thyroxine infusion\n\nThyroxine: Infusion prepared by mixing 500 μg of drug in 500-ml of normal saline (i.e. concentration of 1 μg/ml) and enclosing the bag in an opaque sleeve. Infusion started at 30 μg/hour (30 ml/hour) for twelve hours.'}, {'id': 'OG001', 'title': 'Saline Placebo', 'description': 'Intravenous saline infusion\n\nSaline: The placebo will be a 500-ml bag of normal saline (without active drug) also enclosed in an opaque sleeve. This infusion will also be started at 30 ml/hour for twelve hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '230', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.57', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.01', 'ciLowerLimit': '0.97', 'ciUpperLimit': '1.07', 'groupDescription': '80% power to detect a 10% increase in hearts transplanted', 'statisticalMethod': 'Chi-squared, Corrected', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'One week', 'description': 'Whether heart is transplanted into living recipient', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Graft Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}]}, {'units': 'hearts', 'counts': [{'value': '230', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Thyroxine', 'description': 'Intravenous thyroxine infusion\n\nThyroxine: Infusion prepared by mixing 500 μg of drug in 500-ml of normal saline (i.e. concentration of 1 μg/ml) and enclosing the bag in an opaque sleeve. Infusion started at 30 μg/hour (30 ml/hour) for twelve hours.'}, {'id': 'OG001', 'title': 'Saline Placebo', 'description': 'Intravenous saline infusion\n\nSaline: The placebo will be a 500-ml bag of normal saline (without active drug) also enclosed in an opaque sleeve. This infusion will also be started at 30 ml/hour for twelve hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '224', 'groupId': 'OG000'}, {'value': '213', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.9', 'ciLowerLimit': '-2.3', 'ciUpperLimit': '6.0', 'groupDescription': 'Non-inferiority analysis for thyroxine vs saline', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Six percent margin, assuming 96% graft survival in control group'}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': '30 days', 'description': '30-day graft survival of hearts transplanted from study donors, obtained from SRTR recipient registry', 'unitOfMeasure': 'hearts', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'hearts', 'denomUnitsSelected': 'hearts', 'populationDescription': 'Only out of those hearts that were transplanted (not all study participants)'}, {'type': 'SECONDARY', 'title': 'Time Till Off Vasopressors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '404', 'groupId': 'OG000'}, {'value': '385', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Thyroxine', 'description': 'Intravenous thyroxine infusion\n\nThyroxine: Infusion prepared by mixing 500 μg of drug in 500-ml of normal saline (i.e. concentration of 1 μg/ml) and enclosing the bag in an opaque sleeve. Infusion started at 30 μg/hour (30 ml/hour) for twelve hours.'}, {'id': 'OG001', 'title': 'Saline Placebo', 'description': 'Intravenous saline infusion\n\nSaline: The placebo will be a 500-ml bag of normal saline (without active drug) also enclosed in an opaque sleeve. This infusion will also be started at 30 ml/hour for twelve hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000', 'lowerLimit': '19', 'upperLimit': '31'}, {'value': '25', 'groupId': 'OG001', 'lowerLimit': '19', 'upperLimit': '38'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '72 hours', 'description': 'Time in hours from randomization to when weaned off vasopressors (except vasopressin)', 'unitOfMeasure': 'hours', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'out of those who began study infusion on vasopressors'}, {'type': 'SECONDARY', 'title': 'Weaned Off Vasopressors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '404', 'groupId': 'OG000'}, {'value': '388', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Thyroxine', 'description': 'Intravenous thyroxine infusion\n\nThyroxine: Infusion prepared by mixing 500 μg of drug in 500-ml of normal saline (i.e. concentration of 1 μg/ml) and enclosing the bag in an opaque sleeve. Infusion started at 30 μg/hour (30 ml/hour) for twelve hours.'}, {'id': 'OG001', 'title': 'Saline Placebo', 'description': 'Intravenous saline infusion\n\nSaline: The placebo will be a 500-ml bag of normal saline (without active drug) also enclosed in an opaque sleeve. This infusion will also be started at 30 ml/hour for twelve hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '143', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 hours', 'description': 'Weaned off vasopressors within twelve hours', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'out of those who began the study infusion still on vasopressors (i.e. some had been weaned off prior to infusion)'}, {'type': 'SECONDARY', 'title': 'Time to Order Echo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '409', 'groupId': 'OG000'}, {'value': '385', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Thyroxine', 'description': 'Intravenous thyroxine infusion\n\nThyroxine: Infusion prepared by mixing 500 μg of drug in 500-ml of normal saline (i.e. concentration of 1 μg/ml) and enclosing the bag in an opaque sleeve. Infusion started at 30 μg/hour (30 ml/hour) for twelve hours.'}, {'id': 'OG001', 'title': 'Saline Placebo', 'description': 'Intravenous saline infusion\n\nSaline: The placebo will be a 500-ml bag of normal saline (without active drug) also enclosed in an opaque sleeve. This infusion will also be started at 30 ml/hour for twelve hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000', 'lowerLimit': '11', 'upperLimit': '13'}, {'value': '13', 'groupId': 'OG001', 'lowerLimit': '12', 'upperLimit': '14'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '72 hours', 'description': 'Time till hemodynamic stability permits ordering initial echocardiogram', 'unitOfMeasure': 'hours', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Ejection Fraction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '350', 'groupId': 'OG000'}, {'value': '336', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Thyroxine', 'description': 'Intravenous thyroxine infusion\n\nThyroxine: Infusion prepared by mixing 500 μg of drug in 500-ml of normal saline (i.e. concentration of 1 μg/ml) and enclosing the bag in an opaque sleeve. Infusion started at 30 μg/hour (30 ml/hour) for twelve hours.'}, {'id': 'OG001', 'title': 'Saline Placebo', 'description': 'Intravenous saline infusion\n\nSaline: The placebo will be a 500-ml bag of normal saline (without active drug) also enclosed in an opaque sleeve. This infusion will also be started at 30 ml/hour for twelve hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '59', 'spread': '11', 'groupId': 'OG000'}, {'value': '58', 'spread': '12', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '72 hours', 'description': 'Left ventricular ejection fraction measured on first echocardiography', 'unitOfMeasure': 'percentage of ejection fraction', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'only those who had echocardiography performed after study start'}, {'type': 'SECONDARY', 'title': 'Lungs Transplanted', 'denoms': [{'units': 'Participants', 'counts': [{'value': '419', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Thyroxine', 'description': 'Intravenous thyroxine infusion\n\nThyroxine: Infusion prepared by mixing 500 μg of drug in 500-ml of normal saline (i.e. concentration of 1 μg/ml) and enclosing the bag in an opaque sleeve. Infusion started at 30 μg/hour (30 ml/hour) for twelve hours.'}, {'id': 'OG001', 'title': 'Saline Placebo', 'description': 'Intravenous saline infusion\n\nSaline: The placebo will be a 500-ml bag of normal saline (without active drug) also enclosed in an opaque sleeve. This infusion will also be started at 30 ml/hour for twelve hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '163', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '72 hours', 'description': 'Whether the lungs were transplanted into a living recipient', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Total Organs Transplanted', 'denoms': [{'units': 'Participants', 'counts': [{'value': '419', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Thyroxine', 'description': 'Intravenous thyroxine infusion\n\nThyroxine: Infusion prepared by mixing 500 μg of drug in 500-ml of normal saline (i.e. concentration of 1 μg/ml) and enclosing the bag in an opaque sleeve. Infusion started at 30 μg/hour (30 ml/hour) for twelve hours.'}, {'id': 'OG001', 'title': 'Saline Placebo', 'description': 'Intravenous saline infusion\n\nSaline: The placebo will be a 500-ml bag of normal saline (without active drug) also enclosed in an opaque sleeve. This infusion will also be started at 30 ml/hour for twelve hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '5'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'One week', 'description': 'Total number of organs transplanted (incl. lungs, liver, kidneys, heart, pancreas)', 'unitOfMeasure': 'organs', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Thyroxine', 'description': 'Intravenous thyroxine infusion\n\nThyroxine: Infusion prepared by mixing 500 μg of drug in 500-ml of normal saline (i.e. concentration of 1 μg/ml) and enclosing the bag in an opaque sleeve. Infusion started at 30 μg/hour (30 ml/hour) for twelve hours.'}, {'id': 'FG001', 'title': 'Saline Placebo', 'description': 'Intravenous saline infusion\n\nSaline: The placebo will be a 500-ml bag of normal saline (without active drug) also enclosed in an opaque sleeve. This infusion will also be started at 30 ml/hour for twelve hours.'}], 'periods': [{'title': 'Initial Study Period (12 Hours)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '419'}, {'groupId': 'FG001', 'numSubjects': '419'}]}, {'type': 'Started Assigned Infusion', 'achievements': [{'groupId': 'FG000', 'numSubjects': '411'}, {'groupId': 'FG001', 'numSubjects': '384'}]}, {'type': 'Per-Protocol', 'comment': 'Received assigned intervention for at least six hours', 'achievements': [{'groupId': 'FG000', 'numSubjects': '351'}, {'groupId': 'FG001', 'numSubjects': '374'}]}, {'type': 'Cross-over', 'comment': 'Crossed-over to other intervention within 12 hours', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Stopped Infusion Early', 'achievements': [{'groupId': 'FG000', 'numSubjects': '86'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'comment': 'Refers to completing donor care, with organ allocation outcomes available', 'achievements': [{'groupId': 'FG000', 'numSubjects': '333'}, {'groupId': 'FG001', 'numSubjects': '416'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '86'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}, {'title': 'Open-Label (T4 Beyond 12 Hours)', 'milestones': [{'type': 'STARTED', 'comment': 'Total number of donors eligible to receive open-label', 'achievements': [{'groupId': 'FG000', 'numSubjects': '333'}, {'groupId': 'FG001', 'numSubjects': '416'}]}, {'type': 'COMPLETED', 'comment': 'number who received thyroxine infusion beyond initial 12-hour study period', 'achievements': [{'groupId': 'FG000', 'numSubjects': '209'}, {'groupId': 'FG001', 'numSubjects': '50'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '124'}, {'groupId': 'FG001', 'numSubjects': '366'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '419', 'groupId': 'BG000'}, {'value': '419', 'groupId': 'BG001'}, {'value': '838', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Thyroxine', 'description': 'Intravenous thyroxine infusion\n\nThyroxine: Infusion prepared by mixing 500 μg of drug in 500-ml of normal saline (i.e. concentration of 1 μg/ml) and enclosing the bag in an opaque sleeve. Infusion started at 30 μg/hour (30 ml/hour) for twelve hours.'}, {'id': 'BG001', 'title': 'Saline Placebo', 'description': 'Intravenous saline infusion\n\nSaline: The placebo will be a 500-ml bag of normal saline (without active drug) also enclosed in an opaque sleeve. This infusion will also be started at 30 ml/hour for twelve hours.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '419', 'groupId': 'BG000'}, {'value': '419', 'groupId': 'BG001'}, {'value': '838', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '36', 'spread': '11', 'groupId': 'BG000'}, {'value': '36', 'spread': '10', 'groupId': 'BG001'}, {'value': '36', 'spread': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '403', 'groupId': 'BG000'}, {'value': '400', 'groupId': 'BG001'}, {'value': '803', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '127', 'groupId': 'BG000'}, {'value': '153', 'groupId': 'BG001'}, {'value': '280', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '276', 'groupId': 'BG000'}, {'value': '247', 'groupId': 'BG001'}, {'value': '523', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'missing data for 16 in T4 and 19 in NS group'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White, non-Hispanic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '403', 'groupId': 'BG000'}, {'value': '397', 'groupId': 'BG001'}, {'value': '800', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '252', 'groupId': 'BG000'}, {'value': '278', 'groupId': 'BG001'}, {'value': '530', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'denoms': [{'units': 'Participants', 'counts': [{'value': '403', 'groupId': 'BG000'}, {'value': '397', 'groupId': 'BG001'}, {'value': '800', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '124', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '403', 'groupId': 'BG000'}, {'value': '397', 'groupId': 'BG001'}, {'value': '800', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '123', 'groupId': 'BG002'}]}]}, {'title': 'Asian, Pacific-Islander, other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '403', 'groupId': 'BG000'}, {'value': '397', 'groupId': 'BG001'}, {'value': '800', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Missing data on 16 in T4 and 22 in NS group'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '419', 'groupId': 'BG000'}, {'value': '419', 'groupId': 'BG001'}, {'value': '838', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '419', 'groupId': 'BG000'}, {'value': '419', 'groupId': 'BG001'}, {'value': '838', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Blood Group', 'classes': [{'title': 'O', 'denoms': [{'units': 'Participants', 'counts': [{'value': '419', 'groupId': 'BG000'}, {'value': '419', 'groupId': 'BG001'}, {'value': '838', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '224', 'groupId': 'BG000'}, {'value': '214', 'groupId': 'BG001'}, {'value': '438', 'groupId': 'BG002'}]}]}, {'title': 'A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '419', 'groupId': 'BG000'}, {'value': '419', 'groupId': 'BG001'}, {'value': '838', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '134', 'groupId': 'BG000'}, {'value': '148', 'groupId': 'BG001'}, {'value': '282', 'groupId': 'BG002'}]}]}, {'title': 'B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '419', 'groupId': 'BG000'}, {'value': '419', 'groupId': 'BG001'}, {'value': '838', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}]}]}, {'title': 'AB', 'denoms': [{'units': 'Participants', 'counts': [{'value': '419', 'groupId': 'BG000'}, {'value': '419', 'groupId': 'BG001'}, {'value': '838', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Cause of Death', 'classes': [{'title': 'Anoxia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '403', 'groupId': 'BG000'}, {'value': '397', 'groupId': 'BG001'}, {'value': '800', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '162', 'groupId': 'BG000'}, {'value': '195', 'groupId': 'BG001'}, {'value': '357', 'groupId': 'BG002'}]}]}, {'title': 'Stroke / Cerebrovascular', 'denoms': [{'units': 'Participants', 'counts': [{'value': '403', 'groupId': 'BG000'}, {'value': '397', 'groupId': 'BG001'}, {'value': '800', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '87', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '166', 'groupId': 'BG002'}]}]}, {'title': 'Trauma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '403', 'groupId': 'BG000'}, {'value': '397', 'groupId': 'BG001'}, {'value': '800', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '143', 'groupId': 'BG000'}, {'value': '117', 'groupId': 'BG001'}, {'value': '260', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '403', 'groupId': 'BG000'}, {'value': '397', 'groupId': 'BG001'}, {'value': '800', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'missing demographic data for 16 in T4 and 22 in NS group'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-12-01', 'size': 1352729, 'label': 'Study Protocol: Appendix (Data Forms)', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_003.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-12-07T15:48', 'hasProtocol': True}, {'date': '2021-11-01', 'size': 865886, 'label': 'Study Protocol and Statistical Analysis Plan: Study Protocol and SAP', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_005.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-11-22T12:08', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 838}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2022-12-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-18', 'studyFirstSubmitDate': '2020-05-27', 'resultsFirstSubmitDate': '2023-10-18', 'studyFirstSubmitQcDate': '2020-05-29', 'lastUpdatePostDateStruct': {'date': '2024-01-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-12-18', 'studyFirstPostDateStruct': {'date': '2020-06-04', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-01-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Total Organs Transplanted', 'timeFrame': 'One week', 'description': 'Total number of organs transplanted (incl. lungs, liver, kidneys, heart, pancreas)'}], 'primaryOutcomes': [{'measure': 'Heart Transplanted', 'timeFrame': 'One week', 'description': 'Whether heart is transplanted into living recipient'}, {'measure': 'Graft Function', 'timeFrame': '30 days', 'description': '30-day graft survival of hearts transplanted from study donors, obtained from SRTR recipient registry'}], 'secondaryOutcomes': [{'measure': 'Time Till Off Vasopressors', 'timeFrame': '72 hours', 'description': 'Time in hours from randomization to when weaned off vasopressors (except vasopressin)'}, {'measure': 'Weaned Off Vasopressors', 'timeFrame': '12 hours', 'description': 'Weaned off vasopressors within twelve hours'}, {'measure': 'Time to Order Echo', 'timeFrame': '72 hours', 'description': 'Time till hemodynamic stability permits ordering initial echocardiogram'}, {'measure': 'Ejection Fraction', 'timeFrame': '72 hours', 'description': 'Left ventricular ejection fraction measured on first echocardiography'}, {'measure': 'Lungs Transplanted', 'timeFrame': '72 hours', 'description': 'Whether the lungs were transplanted into a living recipient'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Organ donor'], 'conditions': ['Brain Death', 'Heart Failure']}, 'referencesModule': {'references': [{'pmid': '30689222', 'type': 'BACKGROUND', 'citation': 'Dhar R, Stahlschmidt E, Yan Y, Marklin G. A randomized trial comparing triiodothyronine (T3) with thyroxine (T4) for hemodynamically unstable brain-dead organ donors. Clin Transplant. 2019 Mar;33(3):e13486. doi: 10.1111/ctr.13486. Epub 2019 Feb 12.'}, {'pmid': '31802716', 'type': 'BACKGROUND', 'citation': 'Dhar R, Stahlschmidt E, Marklin G. A Randomized Trial of Intravenous Thyroxine for Brain-Dead Organ Donors With Impaired Cardiac Function. Prog Transplant. 2020 Mar;30(1):48-55. doi: 10.1177/1526924819893295. Epub 2019 Dec 5.'}, {'pmid': '38048188', 'type': 'BACKGROUND', 'citation': 'Dhar R, Marklin GF, Klinkenberg WD, Wang J, Goss CW, Lele AV, Kensinger CD, Lange PA, Lebovitz DJ. Intravenous Levothyroxine for Unstable Brain-Dead Heart Donors. N Engl J Med. 2023 Nov 30;389(22):2029-2038. doi: 10.1056/NEJMoa2305969.'}, {'pmid': '34838132', 'type': 'DERIVED', 'citation': 'Dhar R, Klinkenberg D, Marklin G. A multicenter randomized placebo-controlled trial of intravenous thyroxine for heart-eligible brain-dead organ donors. Trials. 2021 Nov 27;22(1):852. doi: 10.1186/s13063-021-05797-2.'}]}, 'descriptionModule': {'briefSummary': 'This randomized controlled trial will evaluate whether intravenous thyroxine infusion given to brain-dead organ donors who are eligible to donate hearts for 12 hours will result in more hearts transplanted than saline placebo', 'detailedDescription': 'Background: Brain death frequently induces hemodynamic instability and cardiac stunning. Impairments in cardiac performance are major contributors to hearts from otherwise eligible organ donors not being transplanted. Deficiencies in pituitary hormones (including thyroid stimulating hormone) may contribute to hemodynamic instability and replacement of thyroid hormone has been proposed as a means of improving stability and increasing hearts available for transplantation. Intravenous thyroxine is commonly used in donor management. However, small controlled trials have not been able to demonstrate efficacy.\n\nMethods: This multicenter study will involve organ procurement organizations (OPOs) across the country. A total of 800 heart-eligible brain dead organ donors who require vasopressor support will be randomly assigned to intravenous thyroxine for at least 12-hours or saline placebo. The primary study hypothesis is that thyroxine treatment results in more hearts transplanted. Additional outcome measures are time to achieve hemodynamic stability (weaning off vasopressors) and improvement in cardiac ejection fraction on echocardiography.\n\nDiscussion: This will be the largest randomized controlled study to evaluate the efficacy of thyroid hormone treatment for organ donor management. By collaborating across multiple OPOs, it will be able to enroll an adequate number of donors and be powered to definitively answer the critical question of whether treatment increases hearts transplanted and/or provides other hemodynamic benefits.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '55 Years', 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Declared dead by neurologic criteria (brain dead)\n* Authorization for organ donation and research\n* On one or more vasopressors and/or inotropes\n\nExclusion Criteria:\n\n* Brain death declared more than 24 hours prior\n* Only vasopressor is vasopressin\n* Weight \\< 45 kg (100 lbs)\n* Known coronary artery disease or history of myocardial infarction\n* Known valvular heart disease\n* Prior sternotomy or cardiac surgery\n* Donor at VA hospital\n* Received intravenous or oral thyroxine within past month\n* Known HIV+ status\n* Other reason donor is unable to receive study drug (determined by on-site personnel)'}, 'identificationModule': {'nctId': 'NCT04415658', 'briefTitle': 'Intravenous Thyroxine for Heart-Eligible Organ Donors', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'A Multicenter Randomized Placebo-Controlled Trial of Intravenous Thyroxine for Heart-Eligible Brain Dead Organ Donors', 'orgStudyIdInfo': {'id': 'ODRC-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Thyroxine', 'description': 'Intravenous thyroxine infusion', 'interventionNames': ['Drug: Thyroxine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Saline Placebo', 'description': 'Intravenous saline infusion', 'interventionNames': ['Drug: Saline']}], 'interventions': [{'name': 'Thyroxine', 'type': 'DRUG', 'description': 'Infusion prepared by mixing 500 μg of drug in 500-ml of normal saline (i.e. concentration of 1 μg/ml) and enclosing the bag in an opaque sleeve. Infusion started at 30 μg/hour (30 ml/hour) for twelve hours.', 'armGroupLabels': ['Thyroxine']}, {'name': 'Saline', 'type': 'DRUG', 'description': 'The placebo will be a 500-ml bag of normal saline (without active drug) also enclosed in an opaque sleeve. This infusion will also be started at 30 ml/hour for twelve hours.', 'armGroupLabels': ['Saline Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85013', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Donor Network of Arizona', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '92108', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Lifesharing', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '80230', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Donor Alliance', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '32751', 'city': 'Maitland', 'state': 'Florida', 'country': 'United States', 'facility': 'OurLegacy', 'geoPoint': {'lat': 28.62778, 'lon': -81.36312}}, {'zip': '52317', 'city': 'North Liberty', 'state': 'Iowa', 'country': 'United States', 'facility': 'Iowa Donor Network', 'geoPoint': {'lat': 41.74918, 'lon': -91.59795}}, {'zip': '66205', 'city': 'Westwood', 'state': 'Kansas', 'country': 'United States', 'facility': 'Midwest Transplant Network', 'geoPoint': {'lat': 39.04056, 'lon': -94.6169}}, {'zip': '70433', 'city': 'Covington', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Louisiana Organ Procurement Agency', 'geoPoint': {'lat': 30.47549, 'lon': -90.10042}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Mid-America Transplant Services', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '44128', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Lifebanc', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '73132', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'LifeShare of Oklahoma', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Southwest Transplant Alliance', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Organ Sharing Alliance', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '84107', 'city': 'Murray', 'state': 'Utah', 'country': 'United States', 'facility': 'DonorConnect', 'geoPoint': {'lat': 40.66689, 'lon': -111.88799}}, {'zip': '98006', 'city': 'Bellevue', 'state': 'Washington', 'country': 'United States', 'facility': 'LifeCenter Northwest', 'geoPoint': {'lat': 47.61038, 'lon': -122.20068}}], 'overallOfficials': [{'name': 'Rajat Dhar, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Researchers within the study consortium only'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Mid-America Transplant', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Rajat Dhar', 'investigatorAffiliation': 'Washington University School of Medicine'}}}}