Brain Injuries, TraumaticPATOSTBINCT04718935
Nutritional and Metabolic Biomarkers in Prediction of Outcomes After Traumatic Brain Injury: a Patient Cohort Study
An observational study of Brain Injuries, Traumatic, run by Seoul National University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Brain Injuries, Traumatic
- How many people
- 1,200 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Dec 2018to 30 Apr 2024
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cases will be consecutive adult patients with EMS-treated traumatic brain injury and transport to the 5 emergency departments of participating hospitals.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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:
- Establishment of a prospective registry for traumatic brain injury patients
- Identification of nutritional and metabolic biomarkers related to prognosis of traumatic brain injury patients
- Development of a prognosis prediction model using nutritional and metabolic biomarkers
- Development of identification model for high-risk population of disabilities after traumatic brain injury
Read the 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
- Medical subject headings
- Brain Injuries, Traumatic
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival of traumatic brain injury patient
survival, cause of death
Measured: 6 months after traumatic brain injury
Functional outcome of traumatic brain injury patient
Glasgow Outcome Scale
Measured: 6 months after traumatic brain injury
Quality of life of traumatic brain injury patient
EQ-5D
Measured: 6 months after traumatic brain injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start13 Dec 2018
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Injuries, TraumaticStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Foundation of Korea, SMG-SNU Boramae Medical Center, Kyungpook National University Hospital, Chonnam National University Hospital, Chungbuk National University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04718935
- Sponsor's protocol ID
- SNUEMSTBI21
- Acronym
- PATOSTBI
- Status last verified
- Apr 2024
- First submitted
- 20 Jan 2021
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional and Metabolic Biomarkers in Prediction of Outcomes After Traumatic Brain Injury: a Patient Cohort Study
- ClinicalTrials.gov ID
- NCT04718935
- Acronym / sponsor ID
- PATOSTBI / SNUEMSTBI21
- Conditions
- Brain Injuries, Traumatic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- National Research Foundation of Korea, SMG-SNU Boramae Medical Center, Kyungpook National University Hospital, Chonnam National University Hospital, Chungbuk National University Hospital
- Study start
- 13 Dec 2018 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 22 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Establishment of a prospective registry for traumatic brain injury patients
- Identification of nutritional and metabolic biomarkers related to prognosis of traumatic brain injury patients
- Development of a prognosis prediction model using nutritional and metabolic biomarkers
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cases will be consecutive adult patients with EMS-treated traumatic brain injury and transport to the 5 emergency departments of participating hospitals.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Survival of traumatic brain injury patient
Time frame: 6 months after traumatic brain injury
survival, cause of death
Functional outcome of traumatic brain injury patient
Time frame: 6 months after traumatic brain injury
Glasgow Outcome Scale
Quality of life of traumatic brain injury patient
Time frame: 6 months after traumatic brain injury
EQ-5D
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Injuries, Traumatic, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival of traumatic brain injury patient (time frame: 6 months after traumatic brain injury). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2025.