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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

2,000

participants targeted

Target at P75+ for all trials

Timeline

7mo left

Started Aug 2024

Typical duration for all trials

Geographic Reach

1 country

64 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.4 years study duration

Study Progress75%

Aug 2024Dec 2026

First Submitted

Initial submission to the registry

May 16, 2024

Completed

12 days until next milestone

First Posted

Study publicly available on registry

May 28, 2024

Completed

2 months until next milestone

Study Start

First participant enrolled

August 1, 2024

Completed

2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

September 4, 2024

Status Verified

August 1, 2024

Enrollment Period

2.4 years

First QC Date

May 16, 2024

Last Update Submit

August 30, 2024

Conditions

Traumatic Brain Injury

Keywords

Traumatic Brain InjuryBeijing-Tianjin-Hebei regionDatabaseComparative effectiveness of interventionClinical Treatment Guideline

Outcome Measures

Primary Outcomes (1)

Difference in the Extended Glasgow Outcome Score
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.
From discharge up to 12 months postoperatively

Secondary Outcomes (7)

Difference in the Generalized Anxiety Disorder-7 Scale in post-traumatic mental health recovery
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 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
+2 more secondary outcomes

Study Arms (1)

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.

Other: Neurological functionOther: Mental State, cognitive function, and life quality assessmentOther: Peripheral blood testOther: Hematoma test

Interventions

Neurological functionOTHER

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.

TBI Group

Mental State, cognitive function, and life quality assessmentOTHER

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).

TBI Group

Peripheral blood testOTHER

Collect peripheral blood samples from patients.

TBI Group

Hematoma testOTHER

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

TBI Group

Eligibility Criteria

Age1 Year - 89 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.