Comparative Effectiveness of Intervention in Multi-level Hospitals for Acute Traumatic Brain Injury: a Prospective, Multicenter, Observational Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,000
- 试验地点
- 64
- 主要终点
- Difference in the Extended Glasgow Outcome Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Year 至 89 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient (1 years to 89 years) presenting with clinical symptoms of traumatic brain injury
- •Traumatic brain injury verified on cranial computed tomography or magnetic resonance imaging
- •Written informed consent from patients or their next of kin according to the patient's cognitive status
排除标准
- •patients ≥90 years of age
- •patients who did not accept follow-up visits or were unable to complete follow-up assessments
- •patients with incomplete information
- •patients who did not obtain written informed consent
- •patients with concomitant cancer or other serious illnesses
结局指标
主要结局
Difference in the Extended Glasgow Outcome Score
时间窗: 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.
次要结局
- Difference in the Post-Traumatic Stress Disorder Checklist-5 Scale in post-traumatic mental health recovery(From discharge up to 12 months postoperatively)
- Difference in life quality assessment(From discharge up to 12 months postoperatively)
- Difference in the Patient Health Questionnaire-9 Scale in post-traumatic mental health recovery(From discharge up to 12 months postoperatively)
- Difference in the Rivermead Post-Concussive Symptoms Questionnaire Scale in post-traumatic mental health recovery(From discharge up to 12 months postoperatively)
- Difference in the Generalized Anxiety Disorder-7 Scale in post-traumatic mental health recovery(From discharge up to 12 months postoperatively)
- Difference in cognitive function(From discharge up to 12 months postoperatively)
- Rate of complications and adverse events(From discharge up to 12 months postoperatively)
研究者
Weiming Liu
Professor
Beijing Tiantan Hospital