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

NCT ID: NCT04718935

Last Updated: 2025-02-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-12-13
• Study Completion Date: 2024-04-30

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.

Conditions

Brain Injuries, Traumatic

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Research Foundation of Korea

OTHER

Sponsor Role: collaborator

SMG-SNU Boramae Medical Center

OTHER

Sponsor Role: collaborator

Kyungpook National University Hospital

OTHER

Sponsor Role: collaborator

Chonnam National University Hospital

OTHER

Sponsor Role: collaborator

Chungbuk National University Hospital

OTHER

Sponsor Role: collaborator

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

SNUEMSTBI21

Identifier Type: -

Identifier Source: org_study_id