Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-26 @ 2:33 AM
Study NCT ID:
NCT01461902
Status:
COMPLETED
Last Update Posted:
2015-02-02
First Post:
2011-10-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Vasospasm in Pediatric Traumatic Brain Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-30', 'studyFirstSubmitDate': '2011-10-26', 'studyFirstSubmitQcDate': '2011-10-27', 'lastUpdatePostDateStruct': {'date': '2015-02-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vasospasm detection by Transcranial Doppler Ultrasound', 'timeFrame': '8 days', 'description': 'Daily transcranial doppler ultrasound performed in pediatric traumatic head injury patients.'}], 'secondaryOutcomes': [{'measure': 'Detection of biomarkers in pediatric traumatic brain injury', 'timeFrame': '2 days', 'description': 'Detection of a defined set of protein biomarkers from biological samples collected upon enrollment, 12, 24, and 48 hours.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['traumatic brain injury', 'brain injury', 'head injury', 'vasospasm'], 'conditions': ['Brain Injury']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess for vasospasm using Transcranial Doppler (TCD) and brain injury biomarkers, and evaluate neurocognitive outcome data in pediatric traumatic brain injury (TBI) patients who have experienced a mild to severe head injury.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '5 Days', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Pediatric patients who have been admitted for a traumatic brain injury to Duke University Hospital.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. admission to Duke University Children's Hospital;\n2. age 5 days to 15 years;\n3. a diagnosis of a TBI with a GCS 3-15;\n4. capable of adequate TCD ultrasound examination;\n5. and presence of intravenous or arterial access (blood) and/or an EVD for cerebrospinal fluid (CSF) and/or Foley catheter/ability to void unassisted (urine) biomarker collection unless they are excluded based on the exclusion criteria.\n\nExclusion Criteria:\n\n* the presence of previously diagnosed significant neurodevelopmental delay,\n* a diagnosis of non-traumatic intracranial hemorrhage and\n* parents/legal guardians who do not speak or understand English."}, 'identificationModule': {'nctId': 'NCT01461902', 'acronym': 'PTBI', 'briefTitle': 'Vasospasm in Pediatric Traumatic Brain Injury', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Measuring Vasospasm, Biomarkers, and Neurocognitive Outcomes in Pediatric Traumatic Brain Injury', 'orgStudyIdInfo': {'id': 'Pro00027860'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pediatric Traumatic Brain Injury', 'description': 'Children from 5 days to 15 years of age who have been admitted to the hospital with a traumatic brain injury.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Karin Reuter-Rice, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University School of Nursing and School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}