Ignite Creation Date:
2025-12-24 @ 4:25 PM
Ignite Modification Date:
2026-02-17 @ 10:09 PM
Study NCT ID:
NCT02996266
Status:
TERMINATED
Last Update Posted:
2023-09-21
First Post:
2016-12-05
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Impact of Fever Prevention in Brain Injured Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United Kingdom']}, 'conditionBrowseModule': {'meshes': [{'id': 'D005334', 'term': 'Fever'}, {'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D002543', 'term': 'Cerebral Hemorrhage'}, {'id': 'D013345', 'term': 'Subarachnoid Hemorrhage'}], 'ancestors': [{'id': 'D001832', 'term': 'Body Temperature Changes'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D020300', 'term': 'Intracranial Hemorrhages'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007036', 'term': 'Hypothermia, Induced'}, {'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D017679', 'term': 'Cryotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kirsten.hammitt@bd.com', 'phone': '9733077325', 'title': 'Director, Global Clinical Affairs - Urology and Critical Care', 'organization': 'Becton, Dickinson and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Data for all AEs was collected from randomization, up to 30 days. Data for Major Adverse Events was collected from randomization, up to 1 year.', 'description': 'In this study, an MAE was defined as one of the following: Pneumonia, Sepsis, Malignant cerebral edema, or Death.\n\nAll Adverse Events were analyzed using the As Treated (AT) population. This is the same as the Intent to Treat (ITT) population but based on the actual treatment received, not based on randomization, if there are patients who received the treatment other than that which they were randomized to.', 'eventGroups': [{'id': 'EG000', 'title': 'Fever Prevention', 'description': 'Fever will be prevented using a surface targeted temperature management system\n\nTargeted Temperature Management: Prophylactic normothermia', 'otherNumAtRisk': 331, 'deathsNumAtRisk': 339, 'otherNumAffected': 122, 'seriousNumAtRisk': 331, 'deathsNumAffected': 75, 'seriousNumAffected': 150}, {'id': 'EG001', 'title': 'Standard Care', 'description': 'Standard care in which fever may spontaneously develop\n\nStandard Care: No intervention to control temperature unless fever occurs', 'otherNumAtRisk': 336, 'deathsNumAtRisk': 338, 'otherNumAffected': 48, 'seriousNumAtRisk': 336, 'deathsNumAffected': 77, 'seriousNumAffected': 132}], 'otherEvents': [{'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 331, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 336, 'numAffected': 7}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 331, 'numAffected': 73}, {'groupId': 'EG001', 'numAtRisk': 336, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Hypernatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 331, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 336, 'numAffected': 23}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 331, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 336, 'numAffected': 13}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}], 'seriousEvents': [{'term': 'Brain Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 331, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 336, 'numAffected': 29}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 331, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 336, 'numAffected': 48}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 331, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 336, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Cerebral Vasoconstriction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 331, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 336, 'numAffected': 26}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Pneumonia Aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 331, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 336, 'numAffected': 28}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Fever Burden', 'denoms': [{'units': 'Participants', 'counts': [{'value': '339', 'groupId': 'OG000'}, {'value': '338', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fever Prevention', 'description': 'Fever will be prevented using a surface targeted temperature management system\n\nTargeted Temperature Management: Prophylactic normothermia'}, {'id': 'OG001', 'title': 'Standard Care', 'description': 'Standard care in which fever may spontaneously develop\n\nStandard Care: No intervention to control temperature unless fever occurs'}], 'classes': [{'categories': [{'measurements': [{'value': '0.37', 'spread': '0.961', 'groupId': 'OG000'}, {'value': '0.73', 'spread': '1.075', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 14 days', 'description': 'Daily average fever burden (°C-hour)', 'unitOfMeasure': '°C-hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat'}, {'type': 'SECONDARY', 'title': 'Primary Neurologic Outcome: Modified Rankin Scale Short-Term', 'denoms': [{'units': 'Participants', 'counts': [{'value': '339', 'groupId': 'OG000'}, {'value': '338', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fever Prevention', 'description': 'Fever will be prevented using a surface targeted temperature management system\n\nTargeted Temperature Management: Prophylactic normothermia'}, {'id': 'OG001', 'title': 'Standard Care', 'description': 'Standard care in which fever may spontaneously develop\n\nStandard Care: No intervention to control temperature unless fever occurs'}], 'classes': [{'categories': [{'measurements': [{'value': '3.7', 'spread': '1.41', 'groupId': 'OG000'}, {'value': '3.6', 'spread': '1.43', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3-months post injury', 'description': 'Modified Rankin Scale is a 6-category outcome measurement with 0 = no limitations, no symptoms and 6 = death.', 'unitOfMeasure': 'mRS score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat'}, {'type': 'SECONDARY', 'title': 'Other Neurologic Outcomes: NIH Stroke Scale Short-Term', 'denoms': [{'units': 'Participants', 'counts': [{'value': '339', 'groupId': 'OG000'}, {'value': '338', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fever Prevention', 'description': 'Fever will be prevented using a surface targeted temperature management system\n\nTargeted Temperature Management: Prophylactic normothermia'}, {'id': 'OG001', 'title': 'Standard Care', 'description': 'Standard care in which fever may spontaneously develop\n\nStandard Care: No intervention to control temperature unless fever occurs'}], 'classes': [{'categories': [{'measurements': [{'value': '6.3', 'spread': '6.30', 'groupId': 'OG000'}, {'value': '6.7', 'spread': '8.22', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3-months post injury', 'description': 'NIH Stroke Scale is a systematic, quantitative assessment tool to measure stroke-related neurological deficit. Scores range from 0 to 42, with higher scores indicating worse outcome.', 'unitOfMeasure': 'NIHSS Score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat'}, {'type': 'SECONDARY', 'title': 'Other Neurologic Outcomes: Barthel Index Short-Term', 'denoms': [{'units': 'Participants', 'counts': [{'value': '339', 'groupId': 'OG000'}, {'value': '338', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fever Prevention', 'description': 'Fever will be prevented using a surface targeted temperature management system\n\nTargeted Temperature Management: Prophylactic normothermia'}, {'id': 'OG001', 'title': 'Standard Care', 'description': 'Standard care in which fever may spontaneously develop\n\nStandard Care: No intervention to control temperature unless fever occurs'}], 'classes': [{'categories': [{'measurements': [{'value': '61.0', 'spread': '36.35', 'groupId': 'OG000'}, {'value': '59.6', 'spread': '38.14', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3-months post injury', 'description': 'Barthel Index is an assessment of functional independence. Scores range from 0 to 100, with lower scores indicating worse outcome.', 'unitOfMeasure': 'Barthel Index Score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat'}, {'type': 'SECONDARY', 'title': 'Other Neurologic Outcomes: Glasgow Outcome Scale Extended Short-Term', 'denoms': [{'units': 'Participants', 'counts': [{'value': '339', 'groupId': 'OG000'}, {'value': '338', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fever Prevention', 'description': 'Fever will be prevented using a surface targeted temperature management system\n\nTargeted Temperature Management: Prophylactic normothermia'}, {'id': 'OG001', 'title': 'Standard Care', 'description': 'Standard care in which fever may spontaneously develop\n\nStandard Care: No intervention to control temperature unless fever occurs'}], 'classes': [{'categories': [{'measurements': [{'value': '3.4', 'spread': '1.98', 'groupId': 'OG000'}, {'value': '3.6', 'spread': '1.96', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3-months post injury', 'description': 'Glasgow Outcome Scale assesses functional outcome after acute brain injury. Scores range from 1-8, with lower scores indicating worse outcome.', 'unitOfMeasure': 'Glasgow Outcome Scale Extended Score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat'}, {'type': 'SECONDARY', 'title': 'Other Neurologic Outcomes: Montreal Cognitive Assessment Short-Term', 'denoms': [{'units': 'Participants', 'counts': [{'value': '339', 'groupId': 'OG000'}, {'value': '338', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fever Prevention', 'description': 'Fever will be prevented using a surface targeted temperature management system\n\nTargeted Temperature Management: Prophylactic normothermia'}, {'id': 'OG001', 'title': 'Standard Care', 'description': 'Standard care in which fever may spontaneously develop\n\nStandard Care: No intervention to control temperature unless fever occurs'}], 'classes': [{'categories': [{'measurements': [{'value': '17.6', 'spread': '9.42', 'groupId': 'OG000'}, {'value': '19.1', 'spread': '9.62', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3-months post injury', 'description': 'Montreal Cognitive Assessment assesses for cognitive impairment. Scores range from 0-30, with lower scores indicating worse outcome.', 'unitOfMeasure': 'MOCA Score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat'}, {'type': 'SECONDARY', 'title': 'Primary Neurologic Outcome: Modified Rankin Scale Mid-Term', 'denoms': [{'units': 'Participants', 'counts': [{'value': '339', 'groupId': 'OG000'}, {'value': '338', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fever Prevention', 'description': 'Fever will be prevented using a surface targeted temperature management system\n\nTargeted Temperature Management: Prophylactic normothermia'}, {'id': 'OG001', 'title': 'Standard Care', 'description': 'Standard care in which fever may spontaneously develop\n\nStandard Care: No intervention to control temperature unless fever occurs'}], 'classes': [{'categories': [{'measurements': [{'value': '3.5', 'spread': '1.50', 'groupId': 'OG000'}, {'value': '3.4', 'spread': '1.60', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6-months post injury', 'description': 'Modified Rankin Scale is a 6-category outcome measurement with 0 = no limitations, no symptoms and 6 = death.', 'unitOfMeasure': 'mRS score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat'}, {'type': 'SECONDARY', 'title': 'Other Neurologic Outcomes: NIH Stroke Scale Mid-Term', 'denoms': [{'units': 'Participants', 'counts': [{'value': '339', 'groupId': 'OG000'}, {'value': '338', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fever Prevention', 'description': 'Fever will be prevented using a surface targeted temperature management system\n\nTargeted Temperature Management: Prophylactic normothermia'}, {'id': 'OG001', 'title': 'Standard Care', 'description': 'Standard care in which fever may spontaneously develop\n\nStandard Care: No intervention to control temperature unless fever occurs'}], 'classes': [{'categories': [{'measurements': [{'value': '4.9', 'spread': '5.05', 'groupId': 'OG000'}, {'value': '5.6', 'spread': '7.38', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6-months post injury', 'description': 'NIH Stroke Scale is a systematic, quantitative assessment tool to measure stroke-related neurological deficit. Scores range from 0 to 42, with higher scores indicating worse outcome.', 'unitOfMeasure': 'NIHSS Score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat'}, {'type': 'SECONDARY', 'title': 'Other Neurologic Outcomes: Barthel Index Mid-Term', 'denoms': [{'units': 'Participants', 'counts': [{'value': '339', 'groupId': 'OG000'}, {'value': '338', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fever Prevention', 'description': 'Fever will be prevented using a surface targeted temperature management system\n\nTargeted Temperature Management: Prophylactic normothermia'}, {'id': 'OG001', 'title': 'Standard Care', 'description': 'Standard care in which fever may spontaneously develop\n\nStandard Care: No intervention to control temperature unless fever occurs'}], 'classes': [{'categories': [{'measurements': [{'value': '65.4', 'spread': '35.96', 'groupId': 'OG000'}, {'value': '69.0', 'spread': '35.26', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6-months post injury', 'description': 'Barthel Index is an assessment of functional independence. Scores range from 0 to 100, with lower scores indicating worse outcome.', 'unitOfMeasure': 'Barthel Index Score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat'}, {'type': 'SECONDARY', 'title': 'Other Neurologic Outcomes: Glasgow Outcome Scale Extended Mid-Term', 'denoms': [{'units': 'Participants', 'counts': [{'value': '339', 'groupId': 'OG000'}, {'value': '338', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fever Prevention', 'description': 'Fever will be prevented using a surface targeted temperature management system\n\nTargeted Temperature Management: Prophylactic normothermia'}, {'id': 'OG001', 'title': 'Standard Care', 'description': 'Standard care in which fever may spontaneously develop\n\nStandard Care: No intervention to control temperature unless fever occurs'}], 'classes': [{'categories': [{'measurements': [{'value': '3.6', 'spread': '2.21', 'groupId': 'OG000'}, {'value': '3.6', 'spread': '2.22', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6-months post injury', 'description': 'Glasgow Outcome Scale assesses functional outcome after acute brain injury. Scores range from 1-8, with lower scores indicating worse outcome.', 'unitOfMeasure': 'Glasgow Outcome Scale Extended Score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat'}, {'type': 'SECONDARY', 'title': 'Other Neurologic Outcomes: Montreal Cognitive Assessment Mid-Term', 'denoms': [{'units': 'Participants', 'counts': [{'value': '339', 'groupId': 'OG000'}, {'value': '338', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fever Prevention', 'description': 'Fever will be prevented using a surface targeted temperature management system\n\nTargeted Temperature Management: Prophylactic normothermia'}, {'id': 'OG001', 'title': 'Standard Care', 'description': 'Standard care in which fever may spontaneously develop\n\nStandard Care: No intervention to control temperature unless fever occurs'}], 'classes': [{'categories': [{'measurements': [{'value': '19.1', 'spread': '8.93', 'groupId': 'OG000'}, {'value': '20.0', 'spread': '9.30', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6-months post injury', 'description': 'Montreal Cognitive Assessment assesses for cognitive impairment. Scores range from 0-30, with lower scores indicating worse outcome.', 'unitOfMeasure': 'MOCA Score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat'}, {'type': 'SECONDARY', 'title': 'Primary Neurologic Outcome: Modified Rankin Scale Long-Term', 'denoms': [{'units': 'Participants', 'counts': [{'value': '339', 'groupId': 'OG000'}, {'value': '338', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fever Prevention', 'description': 'Fever will be prevented using a surface targeted temperature management system\n\nTargeted Temperature Management: Prophylactic normothermia'}, {'id': 'OG001', 'title': 'Standard Care', 'description': 'Standard care in which fever may spontaneously develop\n\nStandard Care: No intervention to control temperature unless fever occurs'}], 'classes': [{'categories': [{'measurements': [{'value': '3.5', 'spread': '1.58', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '1.64', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12-months post injury', 'description': 'Modified Rankin Scale is a 6-category outcome measurement with 0 = no limitations, no symptoms and 6 = death.', 'unitOfMeasure': 'mRS score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat'}, {'type': 'SECONDARY', 'title': 'Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '331', 'groupId': 'OG000'}, {'value': '336', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fever Prevention', 'description': 'Fever will be prevented using a surface targeted temperature management system\n\nTargeted Temperature Management: Prophylactic normothermia'}, {'id': 'OG001', 'title': 'Standard Care', 'description': 'Standard care in which fever may spontaneously develop\n\nStandard Care: No intervention to control temperature unless fever occurs'}], 'classes': [{'title': 'Any Adverse Event during the Acute Phase', 'categories': [{'measurements': [{'value': '933', 'groupId': 'OG000'}, {'value': '764', 'groupId': 'OG001'}]}]}, {'title': 'Any Adverse Event after the acute phase', 'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}]}, {'title': 'Serious Adverse Event during the acute phase', 'categories': [{'measurements': [{'value': '287', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}]}]}, {'title': 'Serious Adverse Event after the acute phase', 'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From date of randomization until hospital discharge, assessed up to 30 days', 'description': 'An untoward medical occurrence, unintended disease or injury, or unanticipated complication', 'unitOfMeasure': 'Adverse Events', 'reportingStatus': 'POSTED', 'populationDescription': 'As Treated'}, {'type': 'SECONDARY', 'title': 'Major Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '331', 'groupId': 'OG000'}, {'value': '336', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fever Prevention', 'description': 'Fever will be prevented using a surface targeted temperature management system\n\nTargeted Temperature Management: Prophylactic normothermia'}, {'id': 'OG001', 'title': 'Standard Care', 'description': 'Standard care in which fever may spontaneously develop\n\nStandard Care: No intervention to control temperature unless fever occurs'}], 'classes': [{'title': 'MAE through 3 months', 'categories': [{'measurements': [{'value': '213', 'groupId': 'OG000'}, {'value': '201', 'groupId': 'OG001'}]}]}, {'title': 'MAE through 6 months', 'categories': [{'measurements': [{'value': '228', 'groupId': 'OG000'}, {'value': '227', 'groupId': 'OG001'}]}]}, {'title': 'MAE through 12 months', 'categories': [{'measurements': [{'value': '235', 'groupId': 'OG000'}, {'value': '241', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From date of randomization until end of study, assessed up to 12 months', 'description': 'MAEs defined as one of the following: pneumonia, sepsis, malignant cerebral edema, death', 'unitOfMeasure': 'Major Adverse Events', 'reportingStatus': 'POSTED', 'populationDescription': 'As Treated'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '331', 'groupId': 'OG000'}, {'value': '336', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fever Prevention', 'description': 'Fever will be prevented using a surface targeted temperature management system\n\nTargeted Temperature Management: Prophylactic normothermia'}, {'id': 'OG001', 'title': 'Standard Care', 'description': 'Standard care in which fever may spontaneously develop\n\nStandard Care: No intervention to control temperature unless fever occurs'}], 'classes': [{'categories': [{'measurements': [{'value': '112', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From date of randomization until hospital discharge, assessed up to 30 days', 'description': 'Healthcare associated infection', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'As Treated'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Shivering', 'denoms': [{'units': 'Participants', 'counts': [{'value': '339', 'groupId': 'OG000'}, {'value': '338', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fever Prevention', 'description': 'Fever will be prevented using a surface targeted temperature management system\n\nTargeted Temperature Management: Prophylactic normothermia'}, {'id': 'OG001', 'title': 'Standard Care', 'description': 'Standard care in which fever may spontaneously develop\n\nStandard Care: No intervention to control temperature unless fever occurs'}], 'classes': [{'categories': [{'measurements': [{'value': '283', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 14 days', 'description': 'Shivering greater than or equal to 1 on the Bedside Shivering Assessment Scale (BSAS). BSAS scores range from 0-3 with 0 indicating no shivering noted and 3 indicating severe shivering involving gross movements of the trunk and upper and lower extremities.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Hospital Length of Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '339', 'groupId': 'OG000'}, {'value': '338', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fever Prevention', 'description': 'Fever will be prevented using a surface targeted temperature management system\n\nTargeted Temperature Management: Prophylactic normothermia'}, {'id': 'OG001', 'title': 'Standard Care', 'description': 'Standard care in which fever may spontaneously develop\n\nStandard Care: No intervention to control temperature unless fever occurs'}], 'classes': [{'categories': [{'measurements': [{'value': '25.3', 'spread': '17.56', 'groupId': 'OG000'}, {'value': '22.9', 'spread': '16.04', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From date of randomization until hospital discharge, assessed up to 90 days', 'description': 'Overall hospitalization duration', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'ICU Length of Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '339', 'groupId': 'OG000'}, {'value': '338', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fever Prevention', 'description': 'Fever will be prevented using a surface targeted temperature management system\n\nTargeted Temperature Management: Prophylactic normothermia'}, {'id': 'OG001', 'title': 'Standard Care', 'description': 'Standard care in which fever may spontaneously develop\n\nStandard Care: No intervention to control temperature unless fever occurs'}], 'classes': [{'categories': [{'measurements': [{'value': '335.096', 'spread': '294.5559', 'groupId': 'OG000'}, {'value': '312.949', 'spread': '287.0900', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From date of randomization until ICU discharge', 'description': 'ICU Duration', 'unitOfMeasure': 'Hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '339', 'groupId': 'OG000'}, {'value': '338', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fever Prevention', 'description': 'Fever will be prevented using a surface targeted temperature management system\n\nTargeted Temperature Management: Prophylactic normothermia'}, {'id': 'OG001', 'title': 'Standard Care', 'description': 'Standard care in which fever may spontaneously develop\n\nStandard Care: No intervention to control temperature unless fever occurs'}], 'classes': [{'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '7-day (or hospital discharge); 3-, 6-, and 12-months', 'description': 'Mortality', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Fever Prevention', 'description': 'Fever will be prevented using a surface targeted temperature management system\n\nTargeted Temperature Management: Prophylactic normothermia'}, {'id': 'FG001', 'title': 'Standard Care', 'description': 'Standard care in which fever may spontaneously develop\n\nStandard Care: No intervention to control temperature unless fever occurs'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '339'}, {'groupId': 'FG001', 'numSubjects': '338'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '211'}, {'groupId': 'FG001', 'numSubjects': '222'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '128'}, {'groupId': 'FG001', 'numSubjects': '116'}]}]}], 'preAssignmentDetails': 'Subjects screen failed after signing consent (n=9):\n\nDisease-specific criteria (Not met) = 3 Fever at time of study = 1 Fever for more than one hour or one instance prior to study enrollment = 3 Fever at time of randomization = 1 Aneurysmal SAH confirmed within 24 hours of symptom onset = 1'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '339', 'groupId': 'BG000'}, {'value': '338', 'groupId': 'BG001'}, {'value': '677', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Fever Prevention', 'description': 'Fever will be prevented using a surface targeted temperature management system\n\nTargeted Temperature Management: Prophylactic normothermia'}, {'id': 'BG001', 'title': 'Standard Care', 'description': 'Standard care in which fever may spontaneously develop\n\nStandard Care: No intervention to control temperature unless fever occurs'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '339', 'groupId': 'BG000'}, {'value': '338', 'groupId': 'BG001'}, {'value': '677', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '61.0', 'spread': '13.22', 'groupId': 'BG000'}, {'value': '60.4', 'spread': '13.86', 'groupId': 'BG001'}, {'value': '60.7', 'spread': '13.54', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '339', 'groupId': 'BG000'}, {'value': '338', 'groupId': 'BG001'}, {'value': '677', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '177', 'groupId': 'BG000'}, {'value': '168', 'groupId': 'BG001'}, {'value': '345', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '162', 'groupId': 'BG000'}, {'value': '170', 'groupId': 'BG001'}, {'value': '332', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '339', 'groupId': 'BG000'}, {'value': '338', 'groupId': 'BG001'}, {'value': '677', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '307', 'groupId': 'BG000'}, {'value': '312', 'groupId': 'BG001'}, {'value': '619', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '339', 'groupId': 'BG000'}, {'value': '338', 'groupId': 'BG001'}, {'value': '677', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '68', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '134', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '124', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '204', 'groupId': 'BG000'}, {'value': '189', 'groupId': 'BG001'}, {'value': '393', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Austria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '339', 'groupId': 'BG000'}, {'value': '338', 'groupId': 'BG001'}, {'value': '677', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}]}, {'title': 'South Korea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '339', 'groupId': 'BG000'}, {'value': '338', 'groupId': 'BG001'}, {'value': '677', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '112', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '339', 'groupId': 'BG000'}, {'value': '338', 'groupId': 'BG001'}, {'value': '677', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '223', 'groupId': 'BG000'}, {'value': '224', 'groupId': 'BG001'}, {'value': '447', 'groupId': 'BG002'}]}]}, {'title': 'Switzerland', 'denoms': [{'units': 'Participants', 'counts': [{'value': '339', 'groupId': 'BG000'}, {'value': '338', 'groupId': 'BG001'}, {'value': '677', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}, {'title': 'Germany', 'denoms': [{'units': 'Participants', 'counts': [{'value': '339', 'groupId': 'BG000'}, {'value': '338', 'groupId': 'BG001'}, {'value': '677', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'BMI', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '338', 'groupId': 'BG000'}, {'value': '336', 'groupId': 'BG001'}, {'value': '674', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '28.51', 'spread': '6.829', 'groupId': 'BG000'}, {'value': '28.60', 'spread': '6.827', 'groupId': 'BG001'}, {'value': '28.56', 'spread': '6.823', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Missing height and weight for 3 patients to calculate BMI.'}, {'title': 'Clinical Diagnosis', 'classes': [{'title': 'Intracerebral Hemmorrhage (ICH)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '339', 'groupId': 'BG000'}, {'value': '338', 'groupId': 'BG001'}, {'value': '677', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '111', 'groupId': 'BG000'}, {'value': '112', 'groupId': 'BG001'}, {'value': '223', 'groupId': 'BG002'}]}]}, {'title': 'Ischemic Stroke (IS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '339', 'groupId': 'BG000'}, {'value': '338', 'groupId': 'BG001'}, {'value': '677', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '128', 'groupId': 'BG000'}, {'value': '126', 'groupId': 'BG001'}, {'value': '254', 'groupId': 'BG002'}]}]}, {'title': 'Subarachnoid Hemorrhage (SAH)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '339', 'groupId': 'BG000'}, {'value': '338', 'groupId': 'BG001'}, {'value': '677', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Baseline Severity', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '338', 'groupId': 'BG000'}, {'value': '338', 'groupId': 'BG001'}, {'value': '676', 'groupId': 'BG002'}]}], 'categories': [{'title': 'High (NIHSS ≥17, ICH ≥3, or WFNS ≥IV)', 'measurements': [{'value': '156', 'groupId': 'BG000'}, {'value': '158', 'groupId': 'BG001'}, {'value': '314', 'groupId': 'BG002'}]}, {'title': 'Low (NIHSS <17, ICH ≤2, or WFNS ≤III)', 'measurements': [{'value': '182', 'groupId': 'BG000'}, {'value': '180', 'groupId': 'BG001'}, {'value': '362', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Missing severity for 1 patient'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-03-09', 'size': 3601797, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-07-10T17:06', 'hasProtocol': True}, {'date': '2021-03-25', 'size': 597571, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-07-10T17:08', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 686}}, 'statusModule': {'whyStopped': 'Futility', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2022-05-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-25', 'studyFirstSubmitDate': '2016-12-05', 'resultsFirstSubmitDate': '2023-07-10', 'studyFirstSubmitQcDate': '2016-12-14', 'lastUpdatePostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-08-25', 'studyFirstPostDateStruct': {'date': '2016-12-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Hospital Length of Stay', 'timeFrame': 'From date of randomization until hospital discharge, assessed up to 90 days', 'description': 'Overall hospitalization duration'}, {'measure': 'ICU Length of Stay', 'timeFrame': 'From date of randomization until ICU discharge', 'description': 'ICU Duration'}, {'measure': 'Mortality', 'timeFrame': '7-day (or hospital discharge); 3-, 6-, and 12-months', 'description': 'Mortality'}], 'primaryOutcomes': [{'measure': 'Fever Burden', 'timeFrame': 'Up to 14 days', 'description': 'Daily average fever burden (°C-hour)'}], 'secondaryOutcomes': [{'measure': 'Primary Neurologic Outcome: Modified Rankin Scale Short-Term', 'timeFrame': '3-months post injury', 'description': 'Modified Rankin Scale is a 6-category outcome measurement with 0 = no limitations, no symptoms and 6 = death.'}, {'measure': 'Other Neurologic Outcomes: NIH Stroke Scale Short-Term', 'timeFrame': '3-months post injury', 'description': 'NIH Stroke Scale is a systematic, quantitative assessment tool to measure stroke-related neurological deficit. Scores range from 0 to 42, with higher scores indicating worse outcome.'}, {'measure': 'Other Neurologic Outcomes: Barthel Index Short-Term', 'timeFrame': '3-months post injury', 'description': 'Barthel Index is an assessment of functional independence. Scores range from 0 to 100, with lower scores indicating worse outcome.'}, {'measure': 'Other Neurologic Outcomes: Glasgow Outcome Scale Extended Short-Term', 'timeFrame': '3-months post injury', 'description': 'Glasgow Outcome Scale assesses functional outcome after acute brain injury. Scores range from 1-8, with lower scores indicating worse outcome.'}, {'measure': 'Other Neurologic Outcomes: Montreal Cognitive Assessment Short-Term', 'timeFrame': '3-months post injury', 'description': 'Montreal Cognitive Assessment assesses for cognitive impairment. Scores range from 0-30, with lower scores indicating worse outcome.'}, {'measure': 'Primary Neurologic Outcome: Modified Rankin Scale Mid-Term', 'timeFrame': '6-months post injury', 'description': 'Modified Rankin Scale is a 6-category outcome measurement with 0 = no limitations, no symptoms and 6 = death.'}, {'measure': 'Other Neurologic Outcomes: NIH Stroke Scale Mid-Term', 'timeFrame': '6-months post injury', 'description': 'NIH Stroke Scale is a systematic, quantitative assessment tool to measure stroke-related neurological deficit. Scores range from 0 to 42, with higher scores indicating worse outcome.'}, {'measure': 'Other Neurologic Outcomes: Barthel Index Mid-Term', 'timeFrame': '6-months post injury', 'description': 'Barthel Index is an assessment of functional independence. Scores range from 0 to 100, with lower scores indicating worse outcome.'}, {'measure': 'Other Neurologic Outcomes: Glasgow Outcome Scale Extended Mid-Term', 'timeFrame': '6-months post injury', 'description': 'Glasgow Outcome Scale assesses functional outcome after acute brain injury. Scores range from 1-8, with lower scores indicating worse outcome.'}, {'measure': 'Other Neurologic Outcomes: Montreal Cognitive Assessment Mid-Term', 'timeFrame': '6-months post injury', 'description': 'Montreal Cognitive Assessment assesses for cognitive impairment. Scores range from 0-30, with lower scores indicating worse outcome.'}, {'measure': 'Primary Neurologic Outcome: Modified Rankin Scale Long-Term', 'timeFrame': '12-months post injury', 'description': 'Modified Rankin Scale is a 6-category outcome measurement with 0 = no limitations, no symptoms and 6 = death.'}, {'measure': 'Adverse Events', 'timeFrame': 'From date of randomization until hospital discharge, assessed up to 30 days', 'description': 'An untoward medical occurrence, unintended disease or injury, or unanticipated complication'}, {'measure': 'Major Adverse Events', 'timeFrame': 'From date of randomization until end of study, assessed up to 12 months', 'description': 'MAEs defined as one of the following: pneumonia, sepsis, malignant cerebral edema, death'}, {'measure': 'Number of Participants With Infection', 'timeFrame': 'From date of randomization until hospital discharge, assessed up to 30 days', 'description': 'Healthcare associated infection'}, {'measure': 'Number of Subjects With Shivering', 'timeFrame': 'Up to 14 days', 'description': 'Shivering greater than or equal to 1 on the Bedside Shivering Assessment Scale (BSAS). BSAS scores range from 0-3 with 0 indicating no shivering noted and 3 indicating severe shivering involving gross movements of the trunk and upper and lower extremities.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Targeted Temperature Management'], 'conditions': ['Fever', 'Ischemic Stroke', 'Intracerebral Hemorrhage', 'Subarachnoid Hemorrhage']}, 'referencesModule': {'references': [{'pmid': '39320879', 'type': 'DERIVED', 'citation': 'Greer DM, Helbok R, Badjatia N, Ko SB, Guanci MM, Sheth KN; INTREPID Study Group. Fever Prevention in Patients With Acute Vascular Brain Injury: The INTREPID Randomized Clinical Trial. JAMA. 2024 Nov 12;332(18):1525-1534. doi: 10.1001/jama.2024.14745.'}, {'pmid': '33761119', 'type': 'DERIVED', 'citation': 'Greer DM, Ritter J, Helbok R, Badjatia N, Ko SB, Guanci M, Sheth KN. Impact of Fever Prevention in Brain-Injured Patients (INTREPID): Study Protocol for a Randomized Controlled Trial. Neurocrit Care. 2021 Oct;35(2):577-589. doi: 10.1007/s12028-021-01208-1. Epub 2021 Mar 24.'}, {'pmid': '32562686', 'type': 'DERIVED', 'citation': 'Cronberg T, Greer DM, Lilja G, Moulaert V, Swindell P, Rossetti AO. Brain injury after cardiac arrest: from prognostication of comatose patients to rehabilitation. Lancet Neurol. 2020 Jul;19(7):611-622. doi: 10.1016/S1474-4422(20)30117-4.'}]}, 'descriptionModule': {'briefSummary': 'This study will assess the impact of fever prevention on fever burden and short- and long-term neurologic outcomes in brain injured patients. Half of the subjects will undergo fever prevention using a targeted temperature management system and half of the subjects will be treated for fever should it develop.', 'detailedDescription': 'Multiple studies demonstrate that fever / elevated temperature is associated with poor outcomes in brain injured patients; however, there are no conclusive studies that demonstrate that fever prevention/controlled normothermia is associated with better outcomes. This study will be conducted to assess the impact of advanced temperature control to prevent fever in brain injured patients. The fever prevention group will use the Arctic Sun Temperature Management System and will be compared to standard care patients in whom fever may spontaneously develop. If fever develops in a patient in the standard care group, they will be treated with standard fever care measures according to a step-wise algorithm, consisting primarily of intermittent antipyretics (e.g., acetaminophen) and cooling blankets and, when necessary, advanced targeted temperature management devices.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Admitted with a primary neurological diagnosis of ischemic stroke, intracerebral hemorrhage, or subarachnoid hemorrhage\n2. Prior to onset of acute symptoms, was considered functionally independent (mRS 0-2)\n3. Meets disease-specific criteria\n\nExclusion Criteria:\n\n1. Fever (≥38°C) prior to study enrollment\n2. Pre-existing neurological, psychiatric, or other condition that would confound neurological assessment or would make it difficult to accurately assess neurologic and/or functional outcome\n3. Has a pre-morbid condition with poor likelihood of survival to 6 months\n4. Has a pre-morbid mRS ≥3\n5. Diagnosed with brain death\n6. Is undergoing therapeutic hypothermia therapy\n7. Has sustained neurological injury felt to be catastrophic with little chance of recovery\n8. Has a skin condition in which the use of the ArcticGel Pads is contraindicated (i.e., skin that has signs of ulceration, burns, hives, or rash)\n9. Has poor skin integrity or poor tissue perfusion\n10. Participation in a concurrent investigational / interventional study (medical device or drug)'}, 'identificationModule': {'nctId': 'NCT02996266', 'acronym': 'INTREPID', 'briefTitle': 'Impact of Fever Prevention in Brain Injured Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'C. R. Bard'}, 'officialTitle': 'Impact of Fever Prevention in Brain Injured Patients', 'orgStudyIdInfo': {'id': 'BMD-1111'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fever Prevention', 'description': 'Fever will be prevented using a surface targeted temperature management system', 'interventionNames': ['Device: Targeted Temperature Management']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Care', 'description': 'Standard care in which fever may spontaneously develop', 'interventionNames': ['Other: Standard Care']}], 'interventions': [{'name': 'Targeted Temperature Management', 'type': 'DEVICE', 'otherNames': ['Arctic Sun 5000 Temperature Management System'], 'description': 'Prophylactic normothermia', 'armGroupLabels': ['Fever Prevention']}, {'name': 'Standard Care', 'type': 'OTHER', 'description': 'No intervention to control temperature unless fever occurs', 'armGroupLabels': ['Standard Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of Southern California', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University Hospital', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Hospital', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80113', 'city': 'Englewood', 'state': 'Colorado', 'country': 'United States', 'facility': 'Swedish Medical Center', 'geoPoint': {'lat': 39.64777, 'lon': -104.98776}}, {'zip': '06520', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale New Haven Hospital', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '40241', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Norton Neuroscience Institute', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '70112', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Tulane Medical Center', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland Medical Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02118', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston University Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '01655', 'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'University of Massachusetts Worcester', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Hospital', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '49506', 'city': 'Grand Rapids', 'state': 'Michigan', 'country': 'United States', 'facility': 'Spectrum Health Hospitals', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '87131', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'The University of New Mexico Health Science Center', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mount Sinai Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University, New York - 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