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

Capital Medical University

Status: Enrolling

Conditions: Traumatic Brain Injury

Treatments: Other: Peripheral blood test; Other: Neurological function; Other: Mental State, cognitive function, and life quality assessment; Other: Hematoma test

Study type: Observational

Funder types: Other

Identifiers

NCT06429774

SF 2024-1-2042

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 1 to 89 years old

Volunteers: No Healthy Volunteers

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

Trial design

2,000 participants in 1 patient group

TBI Group

Description:

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.

Treatment:

Other: Hematoma test

Other: Mental State, cognitive function, and life quality assessment

Other: Neurological function

Other: Peripheral blood test