NCT06429774

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

Comparative Effectiveness of Intervention in Multi-level Hospitals for Acute Traumatic Brain Injury: a Prospective, Multicenter, Observational Cohort Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 2,000 (estimated)
• Sponsor: Beijing Tiantan Hospital · Academic / Other
• Sex: All
• Age: 1 Year – 89 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Traumatic brain injury (TBI) is associated with significant morbidity, mortality, and disability, profoundly impacting public health. This study aims to establish a database for acute craniocerebral trauma within the Beijing-Tianjin-Hebei region, and compiles indicators of hospital treatment capabilities and patient data, including neuroimaging, clinical progression, and rehabilitation prognoses.The study is bifurcated into two segments: the initial phase surveys the current status of acute treatment outcomes for TBI inpatients across hospitals in the Beijing-Tianjin-Hebei region and conducts a comparative effectiveness analysis to identify the clinical interventions to optimize. Subsequent phases build on the former by applying optimized treatment strategies to improve efficacy and establish collaborative optimized treatment protocols. This is a prospective, multicenter, observational study designed to enroll 2,000 patients under the age of 90 years with traumatic brain injury in the presence of clinical symptoms confirmed by computed tomography or magnetic resonance imaging.The primary outcome is the Extended Glasgow Outcome Score within 12 months. Secondary outcomes include 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). The objective of this study is anticipated to the Beijing-Tianjin-Hebei region a 20 percent increase in the number of cases treated by optimized clinical practice guidelines and a 10 percent decrement in mortality and disability rates among TBI patients in the region.

Conditions

• Traumatic Brain Injury

Interventions

Type	Name	Description
OTHER	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.
OTHER	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).
OTHER	Peripheral blood test	Collect peripheral blood samples from patients.
OTHER	Hematoma test	Collect hematoma fluid, dura mater, and hematoma outer membrane samples from patients.

Timeline

• Start date: 2024-08-01
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2024-05-28
• Last updated: 2024-09-04

Locations

64 sites across 1 country: China