Ignite Creation Date:
2025-12-24 @ 10:45 PM
Ignite Modification Date:
2025-12-25 @ 8:15 PM
Study NCT ID:
NCT04718935
Status:
COMPLETED
Last Update Posted:
2025-02-28
First Post:
2021-01-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Nutritional and Metabolic Biomarkers in Prediction of Outcomes After Traumatic Brain Injury: a Patient Cohort Study
Sponsor:
Seoul National University Hospital
Organization:
Study Overview
Official Title:
Nutritional and Metabolic Biomarkers in Prediction of Outcomes After Traumatic Brain Injury: a Patient Cohort Study
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PATOSTBI
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
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: