Clinical and Molecular Biological Data Collection and Analysis in Patients With TBI

NCT05533060 | Recruiting

• 1 other identifier: 2022-KY-13(K)
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Clinical evaluation is crucial in the clinical diagnosis, treatment, and prognosis prediction in patients with traumatic brain injury (TBI). However, the existing evaluation systems are not perfect, because many factors are not taken into account, for example, there is a lack of molecular diagnostic criteria for evaluating patients with TBI. We attempt to collect the patient's clinical data and combine it with neuroimaging, as well as molecular biomarkers generated by single-cell sequencing to assess their neurological status and outcome. The clinical and molecular data collection and analysis will be helpful to evaluate the patient's neurological condition and predict the patient's outcome more accurately.

Conditions

Traumatic Brain Injury

Keywords

Traumatic brain injury; Molecular biomarkers; Single-cell sequencing; High-throughput sequencing

Outcome Measures

Primary Outcomes (1)

• Accurate assessment of patients' neurological condition

  Using a regression model to explore the relationship between a patient's neurological condition and clinical and molecular biological data

  2022.09-2023.12

Secondary Outcomes (1)

• Predicting patients' outcome accurately

  2022.09-2023.12

Study Arms (2)

TBI group

patients with traumatic brain injury (TBI) treated surgically

Other: No intervention

RN group

relatively normal (RN) participants including patients with other brain diseases, for example, gliomas, meningiomas, and schwannomas, treated surgically

Other: No intervention

Interventions

No intervention OTHER

patients in the groups are treated surgically and brain tissue, CSF, and blood samples, as well as clinical data, neuroimaging data are collected

RN group; TBI group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with traumatic brain injury (TBI) or other brain diseases (gliomas, meningiomas, schwannoma) who are treated surgically

You may qualify if:

• CT/MRI confirmed TBI;
• The time from onset to the emergency room (ER ) within 12h;
• The systolic pressure (SBP) ≥ 90 mmHg;
• Patients willing to participate in this study with signed informed consent.

You may not qualify if:

• Patients who are not suitable for surgery (GCS score 3 points, dilated and fixed bilateral pupils, pregnant women, etc.);
• Pre-injury life expectancy ≤ 1 year (malignant tumor);
• Previous history of acute myocardial infarction, abnormal immune function, and blood-related diseases;
• without informed consent.

Sponsors & Collaborators

• Shanghai 6th People's Hospital: lead

Study Sites (1)

Shanghai 6th People's Hospital

Shanghai, 200233, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

1. Brain tissues removed by decompression in patients with traumatic brain injury (TBI) 2. Cerebrospinal fluid (CSF) 3. Blood

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Hengli Tian, MD, PhD

  Shanghai 6th People's Hospital

  STUDY DIRECTOR

Central Study Contacts

Yang Yang, MD, PhD

CONTACT

18210391762; yang.cne.yang@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Clinical Professor, Supervisor

Study Record Dates

• First Submitted: September 6, 2022
• First Posted: September 8, 2022
• Study Start: September 1, 2022
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: May 6, 2025

Record last verified: 2025-05

Locations

CN (1)