Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Brain Injuries, Traumatic
Design
Observational Model: CohortTime Perspective: Prospective

Participation Requirements

Age
Between 19 years and 125 years
Gender
Both males and females

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 b...

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.

Tracking Information

NCT #
NCT04718935
Collaborators
  • National Research Foundation of Korea
  • SMG-SNU Boramae Medical Center
  • Kyungpook National University Hospital
  • Chonnam National University Hospital
  • Chungbuk National University Hospital
Investigators
Not Provided