Ignite Creation Date:
2025-12-24 @ 9:18 PM
Ignite Modification Date:
2026-01-03 @ 4:57 PM
Study NCT ID:
NCT00676104
Status:
COMPLETED
Last Update Posted:
2013-12-20
First Post:
2008-05-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Discrete Hypothermia in the Management of Traumatic Brain Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D007035', 'term': 'Hypothermia'}], 'ancestors': [{'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D001832', 'term': 'Body Temperature Changes'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-19', 'studyFirstSubmitDate': '2008-05-08', 'studyFirstSubmitQcDate': '2008-05-09', 'lastUpdatePostDateStruct': {'date': '2013-12-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-05-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Perform a comparative analysis of outcome (Glasgow Outcome Score)', 'timeFrame': 'Day 1, day 2, day 3, day 7, day 14, day 21, day 28 and 1 month after injury'}], 'secondaryOutcomes': [{'measure': 'The effectiveness of the Discrete Cerebral Hypothermia System by CoolSystems in maintaining a significant gradient between the core and brain temperatures in study population.', 'timeFrame': 'within 3 days after injury'}, {'measure': 'Functional Independence Measure', 'timeFrame': 'Day 1, day 2, day 3, day 7, day 14, day 21, day 28 and 1 month after injury'}, {'measure': 'Mortality', 'timeFrame': 'Day 1, day 2, day 3, day 7, day 14, day 21, day 28 and 1 month after injury'}, {'measure': 'Confirm the effectiveness of the Discrete Cerebral System in reducing internal brain temperature', 'timeFrame': 'within 3 days after injury'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Traumatic Brain Injury', 'Trauma', 'Hypothermia'], 'conditions': ['Severe Traumatic Brain Injury']}, 'descriptionModule': {'briefSummary': 'The primary goal of this project is to demonstrate the feasibility and clinical benefits of a new rapid treatment for secondary treatment for secondary brain injury called Discrete Cerebral Hypothermia System by CoolSystems, Inc., Berkley, CA. This device induced hypothermia in the adult brain without significant whole body hypothermia. Discrete Cerebral Hypothermia System holds a great potential for protecting the brain from the devastating secondary complications of trauma without the associated deleterious system effects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient is treated for severe traumatic brain injury at Grady Health System, GCS \\< 8\n* Patient is \\>18 years of age\n* Patient requires an Intracranial Pressure (ICP) Probe (part of their routine treatment)\n* Patient is able to receive Discrete Cerebral Hypothermia within 48-hours of hospital admission\n* Patient and/or guardian must speak English (in order to ensure proper Informed Consent)\n* Patient and/or guardian/family must sign an Informed Consent\n\nExclusion Criteria:\n\n* Unwillingness or inability of patient and/or guardian/ family to sign an informed consent\n* Physical placement of cooling cap impedes routine treatment\n* Patient has a core body temperature of 36 degrees C or less at time of assessment'}, 'identificationModule': {'nctId': 'NCT00676104', 'briefTitle': 'Discrete Hypothermia in the Management of Traumatic Brain Injury', 'organization': {'class': 'OTHER', 'fullName': 'Emory University'}, 'officialTitle': 'Discrete Hypothermia in the Management of Traumatic Brain Injury', 'orgStudyIdInfo': {'id': '0584-2005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'interventionNames': ['Device: CoolSystems Discrete Cerebral Hypothermia System']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control', 'interventionNames': ['Device: CoolSystems Discrete Cerebral Hypothermia System']}], 'interventions': [{'name': 'CoolSystems Discrete Cerebral Hypothermia System', 'type': 'DEVICE', 'description': 'The CoolSystems Discrete Cerebral Hypothermia System (DCHS) will be removed from the patients head after 48 hours.', 'armGroupLabels': ['Control', 'Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30303', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University School of Medicine, Grady Health System campus', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}], 'overallOfficials': [{'name': 'Odette A Harris, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emory University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emory University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Designated Investigator', 'investigatorFullName': 'Monique Surles', 'investigatorAffiliation': 'Emory University'}}}}