Brain Injuries, Traumatic
Conditions
Brief summary
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
Detailed description
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.
Interventions
None listed
Sponsors
National Research Foundation of Korea
SMG-SNU Boramae Medical Center
Kyungpook National University Hospital
Chonnam National University Hospital
Chungbuk National University Hospital
Seoul National University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survival of traumatic brain injury patient | 6 months after traumatic brain injury | survival, cause of death |
| Functional outcome of traumatic brain injury patient | 6 months after traumatic brain injury | Glasgow Outcome Scale |
| Quality of life of traumatic brain injury patient | 6 months after traumatic brain injury | EQ-5D |
Countries
South Korea
Outcome results
None listed