NCT04718935

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,200 (actual)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Brain Injuries, Traumatic

Timeline

• Start date: 2018-12-13
• Primary completion: 2024-04-30
• Completion: 2024-04-30
• First posted: 2021-01-22
• Last updated: 2025-02-28

Locations

1 site across 1 country: South Korea