The Value of Combined Detection of Different Blood Biomarkers in the Diagnosis and Treatments of Traumatic Brain Injury

NCT06854835 | Not Yet Recruiting

• 1 other identifier: XJTU1AF2020LSYY-G-269-01
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

TBI, as a potential risk factor, causes a 1.5 times higher risk of neurodegenerative disease to up to 30-70% of TBI patients with neurological symptoms. Brain trauma is an important global medical, public health and social problem. Early diagnosis and effective treatment can effectively reduce the disability rate of patients and the incidence of neurological sequelae, and has increasingly become the focus of the international scientific research community. Exploring blood-based biomarkers has potential clinical value, which can greatly help clinicians to evaluate patients' conditions and develop reasonable plans, and then improve the clinical management and treatment of patients with craniocerebral trauma. Further research work is needed to be done to identify the most effective and efficient biomarker or combination marker strategies for integration into clinical treatment.

Conditions

Brain Injuries, Traumatic; Biomarkers

Outcome Measures

Primary Outcomes (3)

• Full Outline of Unresponsiveness, FOUR

  The FOUR is an questionnaire which has four main assessments: eye opening, exercise, brain stem reflex, and respiratory function. Each item has a full score of 4 and a total score of 16. Brainstem reflex and respiratory function of FOUR are more sensitive than the GCS language score for predicting mortality risk in ICU patients. The total score was 0 to 16, with lower scores indicating a greater probability of death and disability.

  On admission (within 24 hours), 3 days of admission and at discharge (up to 24 weeks)

• Glasgow Outcome Scale-Extended, GOS-E

  GOS-E is a clinical assessment tool for assessing function and quality of life in patients with head trauma. This is an expanded version of the Glasgow Rating Scale, designed to provide a more comprehensive assessment to better understand the patient's recovery. The GOS-E scores were divided into the following categories: 1= death, 2= vegetative state, 3= severe disability, 4= moderate to severe disability, 5= moderate disability, 6= mild disability, 7= good recovery, and 8= complete recovery

  On admission (within 24 hours), 3 days of admission and at discharge (up to 24 weeks)

• Head MRI

  The MRI scan sequence includes the following: 1. 3-pl (positioning image requires preservation of the whole brain, including overhead scalp to all cerebellum) (check the parameters before scanning) 2. T2-FLAIR (predict brain conditions, if abnormal lesions, stop scanning immediately) 3. ESWAN 4. T1-weighted 3D-MPRAGE 5. DTI 6. Resting State (BOLD) (positioning line is parallel to AC-PC line) 7. ASL 8. Axial-T1

  On admission (within 24 hours), 3 days of admission and at discharge (up to 24 weeks)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Eighty voluntary TBI patients were recruited prospectively in strict accordance with the inclusion and exclusion criteria. Patients with TBI were divided into three groups: mild to moderate and severe according to GCS scores. At the same time, 80 limb fracture control group matched by gender, age and education were recruited.

You may qualify if:

• Age: 18-65 years old
• Time of injury: patients with acute traumatic brain injury within 24h
• Glasgow Coma Scale (Glasgow Coma Scale, GCS) score: 13 to 15 for patients with mild traumatic brain injury, 9 to 12 for moderate traumatic brain injury, and 3 to 8 for patients with severe traumatic brain injury
• No other system damage has occurred
• Admitted to hospital for the first diagnosis after the injury

You may not qualify if:

• With a history of neurological or psychiatric disorders
• Traumatic brain injury occurred before the injury
• History of alcohol or substance abuse
• Mild brain trauma is a complication of other injuries (systemic trauma, facial trauma, or spinal cord trauma) or other causes (psychological trauma, language impairment)
• Patients without visits, and incomplete data during treatment

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Central Study Contacts

Zhuonan Wang

CONTACT

15332359525; wangzhuonan@xjtu.edu.cn

Jiawen Hu

CONTACT

15291910551; hujiawen@stu.xjtu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2025
• First Posted: March 3, 2025
• Study Start: March 15, 2025
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: March 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share