Clinical trial NCT04718935: Nutritional and Metabolic Biomarkers in Prediction of Outcomes After Traumatic Brain Injury: a Patient Cohort Study
Official title: Nutritional and Metabolic Biomarkers in Prediction of Outcomes After Traumatic Brain Injury: a Patient Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Injuries, Traumatic
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: National Research Foundation of Korea
name: SMG-SNU Boramae Medical Center
name: Kyungpook National University Hospital
name: Chonnam National University Hospital
name: Chungbuk National University Hospital
First posted: 2021-01-22
Enrollment: 1200
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Cases will be consecutive adult patients with EMS-treated traumatic brain injury and transport to the 5 emergency departments of participating hospitals.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Survival of traumatic brain injury patient
timeFrame: 6 months after traumatic brain injury
measure: Functional outcome of traumatic brain injury patient
timeFrame: 6 months after traumatic brain injury
measure: Quality of life of traumatic brain injury patient
timeFrame: 6 months after traumatic brain injury
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References: