Nutritional and Metabolic Biomarkers in Prediction of Outcomes After Traumatic Brain Injury: A Patient Cohort Study

Study Overview
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Brief Summary
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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 Study Objectives: Establishment of a prospective registry for traumatic brain injury patients Identification of nutritional and metabolic biomarkers related to prognosis of traumatic brain injury patients Development of a prognosis prediction model using nutritional and metabolic biomarkers Development of identification model for high-risk population of disabilities after traumatic brain injury

Detailed Description
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Study design: Multicenter observational cohort study, 5 tertiary teaching hospital emergency departments in Korea Study period: July 2018 to December 2023 (66 months) Study population: Traumatic brain injury patients aged over 18. Cases 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. During 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). Data collection: Following data will be collected Clinical data: Basic demographic and clinical outcomes will be retrieved from medical records. Survey data: Comorbidity, symptom, result of neurologic examination, socioeconomic status (occupation, income etc) data will be collected. Blood 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. Follow-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. Ethics 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.

Official Title
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Nutritional and Metabolic Biomarkers in Prediction of Outcomes After Traumatic Brain Injury: A Patient Cohort Study

Conditions
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Brain Injuries, Traumatic

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged over 18 years old 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) Visiting emergency department of the participating hospital within 72 hours after trauma With confirmed intracranial damage such as cerebral hemorrhage or diffuse axial injury by imaging Exclusion Criteria: People who do not consent to personal information and blood supply for research. With penetrating brain injury Patients with known neurological disease, psychiatric disorder. Pregnant patient 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. Patients who were transported after surgery at the other hospital.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival of traumatic brain injury patient | survival, cause of death | 6 months after traumatic brain injury | 
| Functional outcome of traumatic brain injury patient | Glasgow Outcome Scale | 6 months after traumatic brain injury | 
| Quality of life of traumatic brain injury patient | EQ-5D | 6 months after traumatic brain injury |