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

Last Updated: 2024-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-01

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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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

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Traumatic Brain Injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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TBI Group

TBI patients recruited from neurosurgical departments at 50 medical centers in China have apparent clinical symptoms that are confirmed by computed tomography or magnetic resonance imaging.

The exclusion criteria are those who fulfill one of the following conditions:

1. patients ≥90 years of age;
2. patients who did not accept follow-up visits or were unable to complete follow-up assessments;
3. patients with incomplete information;
4. patients who did not obtain written informed consent;
5. patients with concomitant cancer or other serious illnesses.

Neurological function

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

Collect peripheral blood samples from patients.

Hematoma test

Intervention Type OTHER

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

Interventions

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Neurological function

Intervention Type OTHER

Mental State, cognitive function, and life quality assessment

Intervention Type OTHER

Peripheral blood test

Collect peripheral blood samples from patients.

Intervention Type OTHER

Hematoma test

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

1 Year

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Weiming Liu

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Weiming Liu, M.D.

Role: PRINCIPAL_INVESTIGATOR

Beijing Tiantan Hospital

Locations

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