Nutritional and Metabolic Biomarkers in Prediction of Outcomes After Traumatic Brain Injury: a Patient Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,200
- 试验地点
- 1
- 主要终点
- Survival of traumatic brain injury patient
研究概览
简要总结
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
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Survival of traumatic brain injury patient
时间窗: 6 months after traumatic brain injury
survival, cause of death
Quality of life of traumatic brain injury patient
时间窗: 6 months after traumatic brain injury
EQ-5D
Functional outcome of traumatic brain injury patient
时间窗: 6 months after traumatic brain injury
Glasgow Outcome Scale
次要结局
未报告次要终点