Comparative Effectiveness of Intervention in Multi-level Hospitals for Acute Traumatic Brain Injury(Metric-TBI)

Condition(s) studied

Investigational drug(s) / intervention(s)

Neurological function: Neurological function will be examined using Glasgow Coma Scale (GCS) and Extended Glasgow Outcome Scale (GOSE).The GOSE was created as an advancement from the original GOS. The GOSE score categorizes the prognosis of patients with traumatic brain injury into eight categories.The 8 categories are: Dead, Vegetative State, Lower Severe Disability, Upper Severe Disability, Lower Moderate Disability, Upper Moderate Disability, Lower Good Recovery, and Upper Good Recovery.

Mental State, cognitive function, and life quality assessment: Mental State, cognitive function, and life quality will be examined using the Generalized Anxiety Disorder-7 (GAD-7), Patient Health Questionnaire-9(PHQ-9), Rivermead post-concussion symptoms questionnaire(RPQ), PTSD Checklist-5 Version(PCL-5)，Six-Item Screener（SIS） and 12-Item Short-Form Health Survey version 2(SF-12v2).

Peripheral blood test: Collect peripheral blood samples from patients.

Hematoma test: Collect hematoma fluid, dura mater, and hematoma outer membrane samples from patients.

Study summary

A prospective, multicenter, observational cohort study is designed to compare the effectiveness of intervention in multi-grade hospitals for acute traumatic brain injury and to optimize clinical outcomes.

Eligibility

Primary outcome measure(s)

• Difference in the Extended Glasgow Outcome Score — From discharge up to 12 months postoperatively
  The Extended Glasgow Outcome Scores(GOSE) range from 1 to 8, with higher scores indicating a better outcome. The summary of the scale is below:1.Dead;2. Vegetative State;3. Lower Severe Disability;4. Upper Severe Disability;5. Lower Moderate Disability;6. Upper Moderate Disability;7. Lower Good Recovery;8.Upper Good Recovery.Therefore, a score of 1 represents the worst outcome (death), and a score of 8 represents the best outcome (upper good recovery). The rates of death or severe disability (GOSE scores 1-3) due to traumatic brain injury in the short term (at discharge) and in the long term (3, 6, and 12 months post-discharge) give an indication of the extent to which a patient recovers from different treatments.

Trial sites (64)

+ 24 more sites — see the full list on the official registry below.

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