Rapid Diagnosis and Prognosis Recognition of Imaging and Biomarkers in Mild to Moderate Traumatic Brain Injury

January 3, 2022 updated by: First Affiliated Hospital Xi'an Jiaotong University
The investigators will carry out multi-center and large sample research based on the Chinese population, screen the optimal diagnostic and prognosis recognition biomarkers and analyze the diagnostic critical cutoff values in patients with mild to moderate traumatic brain injury, so as to provide a substantial basis for clinical diagnosis and prognosis recognition.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Traumatic brain injury (TBI) is a complex disorder that comprises a spectrum of intracranial pathologies, many of which present diagnostic challenges. Detection of intracranial injuries after TBI relies on head CT, which is overused and resource intensive. Prior studies have shown the potential for blood-based brain injury biomarkers to predict the absence of intracranial injury after TBI and aid in reducing unnecessary head CT use. Furthermore, plasma biomarker concentrations in the acute phase after TBI identified patients with a suspected TBI and normal head CT who had detectable pathology on MRI. However, most of the current studies are based on the European and American population, and whether the research results are applicable to the Chinese population remains to be studied. Therefore, the investigators will carry out multi-center and large sample research based on the Chinese population, screen the optimal diagnostic and prognosis recognition biomarkers and analyze the diagnostic critical cutoff values, so as to provide a substantial basis for clinical diagnosis and prognosis recognition.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • Recruiting
        • First Affiliated Hospital of Xian Jiaotong University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

TBI patients will be recruited from the emergency department of hospital.

Description

Inclusion Criteria:

  • age 18-75 years at time of recruitment.
  • Glasgow Coma Scale (GCS) score of 9-15 at the time of informed consent.
  • non-penetrating TBI resulting from an external force.
  • diagnosed within 1 week after onset of TBI.
  • provision of informed written consent.

Exclusion Criteria:

  • acute suspected stroke, neurosurgery, stroke or TIA within the last 30 days.
  • neurodegenerative disease or other neurological disorder including dementia, Parkinson's disease, multiple sclerosis, seizure disorder, brain tumors.
  • a history of a previous brain injury, or a history of concurrent substance or alcohol abuse;
  • the manifestation of TBI caused by medications, alcohol, drugs for other injuries (such as systemic injuries, facial injuries, or intubation).
  • pregnancy or breastfeeding.
  • Patients with contraindications to MRI scanning (such as patients with metal implants in their bodies, cardiac pacemakers, dentures, etc.)
  • participation in a clinical research study with potential to affect the results of this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
mild to moderate traumatic brain injury
patients diagnosed with mild to moderate traumatic brain injury within 1 week after onset of TBI.
Device: MRI, CT, and serum biomarkers
magnetic resonance image Imaging data were collected in a strong magnetic field, and collected the serum of participants.
isolated orthopaedic trauma patients
Patients with isolated orthopaedic trauma were identified and enrolled using the same process as that for patients with TBI.
Device: MRI, CT, and serum biomarkers
magnetic resonance image Imaging data were collected in a strong magnetic field, and collected the serum of participants.
healthy non-injury control
Healthy non-injured controls were recruited either via a relationship with a TRACK-TBI participant or through public advertisement within TRACK-TBI institutions, and were able to provide informed consent.
Device: MRI, CT, and serum biomarkers
magnetic resonance image Imaging data were collected in a strong magnetic field, and collected the serum of participants.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The concentration of serum biomarkers.
Time Frame: baseline (early injury), post-traumatic for 3 months, 6 months, and 12 months.
the concentration of GFAP with pg/mL, S-100B with pg/mL，IL-6 with pg/mL, IL-8 with pg/mL, IL-10 with pg/mL, IL-1β with pg/mL, TNF-α with pg/mL, UCH-L1 with pg/mL, NSE with pg/mL, T-Tau with pg/mL, P-Tau with pg/mL, NFL with pg/mL, BDNF with pg/mL, and VEGF with pg/mL;
baseline (early injury), post-traumatic for 3 months, 6 months, and 12 months.
Score of Extended Glasgow Outcome Scale.
Time Frame: post-traumatic for 3 months
The functional outcome of TBI patients. The minimum value is 1, and the maximum value is 8. The higher scores mean a better outcome.
post-traumatic for 3 months
Score of Extended Glasgow Outcome Scale.
Time Frame: post-traumatic for 6 months
The functional outcome of TBI patients. The minimum value is 1, and the maximum value is 8. The higher scores mean a better outcome.
post-traumatic for 6 months
Score of Extended Glasgow Outcome Scale.
Time Frame: post-traumatic for 12 months
The functional outcome of TBI patients. The minimum value is 1, and the maximum value is 8. The higher scores mean a better outcome.
post-traumatic for 12 months
Number of participants with positive head CT scan
Time Frame: baseline (early injury)
CT-positive was defined as the presence of one or more of the following injuries: acute epidural haematoma, acute subdural haematoma, indeterminate extraaxial haemorrhage, intraventricular haemorrhage, parenchymal haematoma, petechial haemorrhagic or bland sheer injury, subarachnoid haemorrhage, brain oedema, brain herniation, non-haemorrhagic contusion, ventricular compression, ventricular trapping, cranial fractures, depressed skull fractures, facial fractures, scalp injury, or skull base fractures.
baseline (early injury)
Number of participants with MRI abnormalities
Time Frame: baseline (early injury)
MRI abnormalities were quantified according to common data elements standards and definitions by three board-certified neuroradiologists masked to the identity and clinical history of the patient. MRI scans were read as positive if there was evidence of acute intracranial pathology consistent with TBI (eg, contusion, traumatic axonal injury, diffuse axonal injury).
baseline (early injury)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline brain structure measures at 3 months
Time Frame: baseline (early injury), post-traumatic for 3 months.
The changes of brain volume (mm3) are evaluated by structural MRI
baseline (early injury), post-traumatic for 3 months.
Change from baseline brain structure measures at 6 months
Time Frame: baseline (early injury), post-traumatic for 6 months.
The changes of brain volume (mm3) are evaluated by structural MRI
baseline (early injury), post-traumatic for 6 months.
Change from baseline brain structure measures at 12 months
Time Frame: baseline (early injury), post-traumatic for 12 months.
The changes of brain volume (mm3) are evaluated by structural MRI
baseline (early injury), post-traumatic for 12 months.
White matter integrity at baseline (early injury), post-traumatic for 3 months,6 months, and 12 months.
Time Frame: baseline (early injury), post-traumatic for 3 months,6 months, and 12 months.
The white matter integrity are characterized by fractional anisotropy (FA) which calculated by diffusion tensor imaging.
baseline (early injury), post-traumatic for 3 months,6 months, and 12 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
First Affiliated Hospital Xi'an Jiaotong University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Xijing Hospital
Second Affiliated Hospital of Wenzhou Medical University
Central South University
School of Life Science and Technology, Xi'an Jiaotong University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ming Zhang, PhD, First Affiliated Hospital of Xian Jiaotong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2025

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 24, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 5, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 4, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 3, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 82071993-2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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