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

NCT04718935 | Completed

• 1 other identifier: SNUEMSTBI21
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

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. 1.Establishment of a prospective registry for traumatic brain injury patients
2. 2.Identification of nutritional and metabolic biomarkers related to prognosis of traumatic brain injury patients
3. 3.Development of a prognosis prediction model using nutritional and metabolic biomarkers
4. 4.Development of identification model for high-risk population of disabilities after traumatic brain injury

Conditions

Brain Injuries, Traumatic

Outcome Measures

Primary Outcomes (3)

• Survival of traumatic brain injury patient

  survival, cause of death

  6 months after traumatic brain injury

• Functional outcome of traumatic brain injury patient

  Glasgow Outcome Scale

  6 months after traumatic brain injury

• Quality of life of traumatic brain injury patient

  EQ-5D

  6 months after traumatic brain injury

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seoul National University Hospital: lead
• National Research Foundation of Korea: collaborator
• SMG-SNU Boramae Medical Center: collaborator
• Kyungpook National University Hospital: collaborator
• Chonnam National University Hospital: collaborator
• Chungbuk National University Hospital: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Biospecimen

Retention: SAMPLES WITH DNA

To investigate biomarkers, 20ml of blood is collected from study subjects. Blood is collected first in 2 SST tubes that do not contain anticoagulant, and then blood is collected in 1 EDTA tube containing anticoagulant. Leave blood sample at room temperature for 1 hour and then centrifuge for 10 minutes. Finally, the sample separated by serum, plasma, and buffy coat is stored frozen.

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2021
• First Posted: January 22, 2021
• Study Start: December 13, 2018
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: February 28, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)