Seoul National University Hospital
Seoul, 110-744, South Korea
NCT Number: NCT04718935
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:
1. Establishment of a prospective registry for traumatic brain injury patients 2. Identification of nutritional and metabolic biomarkers related to prognosis of traumatic brain injury patients 3. Development of a prognosis prediction model using nutritional and metabolic biomarkers 4. Development of identification model for high-risk population of disabilities after traumatic brain injury
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Notify Me19 year and older
All sexes
Observational
Seoul, 110-744, South Korea
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 6 months after traumatic brain injury
survival, cause of death
Time frame: 6 months after traumatic brain injury
Glasgow Outcome Scale
Time frame: 6 months after traumatic brain injury
EQ-5D
Seoul National University Hospital
Other
Acronym: PATOSTBI
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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