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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04718935
Other study ID # SNUEMSTBI21
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
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