Ignite Creation Date:
2025-12-24 @ 10:45 PM
Ignite Modification Date:
2025-12-25 @ 8:15 PM
Study NCT ID:
NCT04718935
Status:
COMPLETED
Last Update Posted:
2025-02-28
First Post:
2021-01-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Nutritional and Metabolic Biomarkers in Prediction of Outcomes After Traumatic Brain Injury: a Patient Cohort Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}], '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': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'To investigate biomarkers, 20ml of blood is collected from study subjects. Blood is collected first in 2 SST tubes that do not contain anticoagulant, and then blood is collected in 1 EDTA tube containing anticoagulant. Leave blood sample at room temperature for 1 hour and then centrifuge for 10 minutes. Finally, the sample separated by serum, plasma, and buffy coat is stored frozen.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1200}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-25', 'studyFirstSubmitDate': '2021-01-20', 'studyFirstSubmitQcDate': '2021-01-20', 'lastUpdatePostDateStruct': {'date': '2025-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survival of traumatic brain injury patient', 'timeFrame': '6 months after traumatic brain injury', 'description': 'survival, cause of death'}, {'measure': 'Functional outcome of traumatic brain injury patient', 'timeFrame': '6 months after traumatic brain injury', 'description': 'Glasgow Outcome Scale'}, {'measure': 'Quality of life of traumatic brain injury patient', 'timeFrame': '6 months after traumatic brain injury', 'description': 'EQ-5D'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Brain Injuries, Traumatic']}, 'descriptionModule': {'briefSummary': 'To identify nutritional and metabolic biomarkers that are related to the prognosis of traumatic brain injury patients, and to develop a prognosis prediction model using biomarkers\n\nStudy Objectives:\n\n1. Establishment of a prospective registry for traumatic brain injury patients\n2. Identification of nutritional and metabolic biomarkers related to prognosis of traumatic brain injury patients\n3. Development of a prognosis prediction model using nutritional and metabolic biomarkers\n4. Development of identification model for high-risk population of disabilities after traumatic brain injury', 'detailedDescription': 'Study design: Multicenter observational cohort study, 5 tertiary teaching hospital emergency departments in Korea\n\nStudy period: July 2018 to December 2023 (66 months)\n\nStudy population: Traumatic brain injury patients aged over 18.\n\nCases will be consecutive adult patients with EMS-treated traumatic brain injury and transport to the 5 emergency departments of participating hospitals within 72 hours after the trauma and confirmed cerebral hemorrhage or diffuse axial injury by radiological examination. A prospective traumatic brain injury patient cohort will be developed and all survived traumatic brain injury cases will be followed at 1-month and 6-month after ED discharge by telephone.\n\nDuring the study period, the investigators aim to recruit a total 1,200 cases (600 cases between July 2018 and June 2020, 600 cases between March 2021 and June 2023).\n\nData collection: Following data will be collected\n\nClinical data: Basic demographic and clinical outcomes will be retrieved from medical records.\n\nSurvey data: Comorbidity, symptom, result of neurologic examination, socioeconomic status (occupation, income etc) data will be collected.\n\nBlood samples: The investigators aim to develop nutritional and metabolic biomarkers of traumatic brain injury. The investigators also plan to further develop traumatic brain injury biomarkers using proteomics.\n\nFollow-ups: All survived traumatic brain injury cases will be followed-up at 1-month and 6-month after ED discharge and their survival, disability, and quality of life outcomes will be collected by telephone.\n\nEthics Statements: All 5 hospitals participating in the study were IRB approved(Seoul National University Hospital(IRB No: 1806-078-951), SMG-SNU Boramae Medical Center(IRB No: 30-2018-85), Kyungpook National University Hospital(IRB No: 2018-10-014-007), Chonnam National University Hospital(IRB No: CNUH-2018-297), Chungbuk National University Hospital(IRB No: 2018-09-018)). All study patients was registered in cohort after acquisition of consent.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Cases will be consecutive adult patients with EMS-treated traumatic brain injury and transport to the 5 emergency departments of participating hospitals.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged over 18 years old\n* Traumatic brain injury patient transported by EMS ambulance to the emergency department of the participating hospital or transporting from another hospital emergency room (EMS treated traumatic brain injury)\n* Visiting emergency department of the participating hospital within 72 hours after trauma\n* With confirmed intracranial damage such as cerebral hemorrhage or diffuse axial injury by imaging\n\nExclusion Criteria:\n\n* People who do not consent to personal information and blood supply for research.\n* With penetrating brain injury\n* Patients with known neurological disease, psychiatric disorder.\n* Pregnant patient\n* Patients with a terminal condition known to have no further treatment plans due to malignancy. The terminal condition had to be checked by a doctor or recorded in medical records.\n* Patients who were transported after surgery at the other hospital.'}, 'identificationModule': {'nctId': 'NCT04718935', 'acronym': 'PATOSTBI', 'briefTitle': 'Nutritional and Metabolic Biomarkers in Prediction of Outcomes After Traumatic Brain Injury: a Patient Cohort Study', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Nutritional and Metabolic Biomarkers in Prediction of Outcomes After Traumatic Brain Injury: a Patient Cohort Study', 'orgStudyIdInfo': {'id': 'SNUEMSTBI21'}}, 'contactsLocationsModule': {'locations': [{'zip': '110-744', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Research Foundation of Korea', 'class': 'OTHER'}, {'name': 'SMG-SNU Boramae Medical Center', 'class': 'OTHER'}, {'name': 'Kyungpook National University Hospital', 'class': 'OTHER'}, {'name': 'Chonnam National University Hospital', 'class': 'OTHER'}, {'name': 'Chungbuk National University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}