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Completed

NCT Number: NCT04718935

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

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

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Hospital

Seoul, 110-744, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Survival of traumatic brain injury patient

    Time frame: 6 months after traumatic brain injury

    survival, cause of death

  2. Functional outcome of traumatic brain injury patient

    Time frame: 6 months after traumatic brain injury

    Glasgow Outcome Scale

  3. Quality of life of traumatic brain injury patient

    Time frame: 6 months after traumatic brain injury

    EQ-5D

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

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

Registry information

Acronym: PATOSTBI

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Jan 22, 2021
Registry last updated
Feb 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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