About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial 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.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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.
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
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
Locations
Sponsors and contacts
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