The s100β Levels in Patients With Mild Brain Injury.

NCT06131242 | Not Yet Recruiting DMC

• 1 other identifier: YXLL-KY-2023(109)
• Study Type: observational
• Target: 494
• Locations: 0 countries
• Sites: N/A

Brief Summary

Mild traumatic brain injury (TBI) accounts for the majority of TBI. At present, whether TBI has traumatic intracranial lession is mainly diagnosed by computed tomography (CT), while only 5% of mild TBI has positive CT results. The risk stratification method for patients with mild TBI is needed to reduce unnecessary CT use and reduce medical costs. S100β is a protein in glial cells and can be used as a biomarker of brain injury. S100β is showed to have the clinical and economic value in ruling out traumatic intracranial lesions in mild TBI patients in Europe and the United States. However, it was showed to have difference between races, and there lacks systematic research data from Chinese population. In addition, if it is used for emergency departments, it is necessary to evaluate new rapid detection methods. This study is based on a novel fast S100β test. The reference intervals of S100β in Chinese adults will be established. Further, evaluation of S100β in diagnosis of traumatic intracranial lesions in acute mild TBI will be conducted from the perspective of clinical and economic value in China, which will provide data for screening of low-risk TBI patients and avoiding unnecessary CT use in clinical practice.

Conditions

Brain Concussion

Outcome Measures

Primary Outcomes (1)

• The serum s100β levels

  2024.6-2026.6

Study Arms (1)

According to age, the group was divided into 18-45, 45-65, and > 65 years old.

Other: It is an observational study

Interventions

It is an observational study OTHER

It is an observational study

According to age, the group was divided into 18-45, 45-65, and > 65 years old.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

healthy people or patients with mild traumatic brain injury.

You may qualify if:

• Study on healthy people: Apparently healthy people \>18 years old who came to our hospital for physical examination.
• Study of emergency trauma patients: 1) Emergency trauma patients at least 18 years old with suspected brain injury; 2) Glasgow Coma Score 13-15 (patients with mild traumatic brain injury); 3) Closed head trauma; 4) Clinical judgment of patients requiring craniocerebral CT examination.

You may not qualify if:

• Healthy population study: stroke history, trauma, surgery, mental illness, senile dementia, cognitive impairment, and tumor patients within 3 months.

Sponsors & Collaborators

• Sumei Lu: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Officials

• Sumei Lu

  STUDY DIRECTOR

Central Study Contacts

Sumei Lu

CONTACT

18615218391; lsmqianyi@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 9, 2023
• First Posted: November 14, 2023
• Study Start: November 9, 2023
• Primary Completion: April 30, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share