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

Recruiting

• Conditions: Traumatic Brain Injury

• Registration Number: NCT06429774
• Lead Sponsor: Beijing Tiantan Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2024-05-16
• Study First Submitted QC: 2024-05-23
• Study First Posted: 2024-05-28
• Status Verified: 2024-08
• Study Start: 2024-08-01
• Last Update Submitted: 2024-08-08
• Last Update Posted: 2024-08-09
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Difference in the Post-Traumatic Stress Disorder Checklist-5 Scale in post-traumatic mental health recovery	From discharge up to 12 months postoperatively	Patients were scored on their subsequent level of mental health at 3, 6, and 12 months after discharge based on the Post-Traumatic Stress Disorder Checklist-5 (PCL-5). Each of the 20 items on the PCL-5 is rated on a scale from 0 ("Not at all") to 4 ("Extremely"). The PCL-5 score ranges from 0 to 80, with higher scores indicating worse Post-traumatic stress disorder(PTSD) symptoms.
Difference in life quality assessment	From discharge up to 12 months postoperatively	Patients were scored on their subsequent level of quality of life at 3, 6, and 12 months after discharge based on different scores on the 12-item Short-Form Health Survey 2 (SF-12v2).; The SF-12v2 provides two summary scores: the Physical Component Summary (PCS) score and the Mental Component Summary (MCS) score. For both the PCS and MCS scores range from 0(the lowest level of health) to 100(the highest level of health). Higher scores on the PCS and MCS indicate better physical and mental health, respectively.
Difference in the Patient Health Questionnaire-9 Scale in post-traumatic mental health recovery	From discharge up to 12 months postoperatively	Patients were scored on their subsequent level of mental health at 3, 6, and 12 months after discharge based on the Patient Health Questionnaire-9 Scale(PHQ-9).; The PHQ-9 scale consists of nine items, each describing a symptom of depression, and respondents rate how often they've been bothered by each symptom over the past two weeks. The PHQ-9 scores between 10-14 suggest moderate depression, on a scale ranging from 0 (minimal depression) to 27 (severe depression), with higher scores indicating worse outcomes.
Difference in the Rivermead Post-Concussive Symptoms Questionnaire Scale in post-traumatic mental health recovery	From discharge up to 12 months postoperatively	Patients were scored on their subsequent level of mental health at 3, 6, and 12 months after discharge based on the Rivermead Post-Concussive Symptoms Questionnaire(RPQ).; The RPQ score ranges from 0 (no symptoms) to 64 (severe symptoms). Higher scores on the RPQ indicate a greater severity of post-concussive symptoms and a worse outcome. This information helps healthcare providers assess the impact of the concussion on the patient's daily life and track their recovery progress.
Difference in the Generalized Anxiety Disorder-7 Scale in post-traumatic mental health recovery	From discharge up to 12 months postoperatively	Patients were scored on their subsequent level of mental health at 3, 6, and 12 months after discharge based on the Generalized Anxiety Disorder-7 Scale(GAD-7).; The GAD-7 scale consists of seven items, each describing a symptom of Generalized Anxiety Disorder(GAD), and respondents rate how often they've been bothered by each symptom over the past two weeks.The GAD-7 score of 10 suggests moderate anxiety, on a scale ranging from 0 (minimal anxiety) to 21 (severe anxiety), with higher scores indicating worse outcomes.
Difference in cognitive function	From discharge up to 12 months postoperatively	Patients were scored on their subsequent level of cognitive function at 3, 6, and 12 months after discharge based on different scores on the Six-Item Screener (SIS).; The SIS is a brief cognitive assessment tool used primarily to screen for cognitive impairment. The SIS assesses orientation and recall, two critical components often affected in cognitive disorders such as dementia.It ranges from 0 to 6, with higher scores mean a better outcome in terms of cognitive function.
Rate of complications and adverse events	From discharge up to 12 months postoperatively	Rates of complications and adverse events during hospitalization and 12 months after discharge.

Trial Locations

Locations (64)

Langfang People's Hospital; 🇨🇳 Langfang, Hebei, China

Beijing Fengtai You'anmen Hospital; 🇨🇳 Beijing, Beijing, China

Beijing Huairou Hospital; 🇨🇳 Beijing, Beijing, China

Beijing Luhe Hospital,Capital Medical University; 🇨🇳 Beijing, Beijing, China

Beijing Red Cross Emergency Medical Center; 🇨🇳 Beijing, Beijing, China

Beijing Tsinghua Changgung Hospital; 🇨🇳 Beijing, Beijing, China

Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China

Beijing Chaoyang Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China

Beijing Chaoyang Integrative Medicine Rescue And First Aid Hospital; 🇨🇳 Beijing, Beijing, China

Beijing Daxing District People's Hospital; 🇨🇳 Beijing, Beijing, China

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