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

Brain Injuries, Traumatic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04718935
• Other study ID #: SNUEMSTBI21
• Status: Recruiting
• Start date: December 13, 2018
• Est. completion date: February 2024

Study information

• Verified date: January 2022
• Source: Seoul National University Hospital
• Contact: Hanna Yoon, MD
• Phone: 82-10-6450-8617
• Email: hannayoon86[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: February 2024
• Est. primary completion date: February 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Wounds and Injuries

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (6)

Lead Sponsor	Collaborator
Seoul National University Hospital	Chonnam National University Hospital, Chungbuk National University Hospital, Kyungpook National University Hospital, National Research Foundation of Korea, SMG-SNU Boramae Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival of traumatic brain injury patient	survival, cause of death	6 months after traumatic brain injury
Primary	Functional outcome of traumatic brain injury patient	Glasgow Outcome Scale	6 months after traumatic brain injury
Primary	Quality of life of traumatic brain injury patient	EQ-5D	6 months after traumatic brain injury