Application of Circulating Extracellular Vesicles in Early Disease Assessment and Prognosis After Traumatic Brain Injury

NCT05279599 | Unknown DMC

• 1 other identifier: TDSJWKTBIEX
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study was to observe the relationship between the changes of circulating extracellular vesicles and disease development and outcome in patients with traumatic brain injury, and to find early serum markers and potential intervention targets for disease monitoring in patients with traumatic brain injury. In addition, explore the source of extracellular vesicles as much as possible to prepare for subsequent basic experiments.

Conditions

Traumatic Brain Injury

Keywords

molecular markers; prognosis; inflammation; peripheral circulation

Outcome Measures

Primary Outcomes (2)

• The type and content of circulating extracellular vesicles

  After isolation of circulating extracellular vesicles, RNA sequencing was performed to determine noncoding RNA changes in circulating extracellular vesicles. Screening criteria were based on logFC and P value, generally with \|logFC\|\>2 and AP value \<0.05 to define whether there was a difference.

  within 24 hours of TBI

• Neurological deterioration in patients with traumatic brain injury

  Neurological deterioration (ND) was defined as the occurrence of one or more of the following criteria within 7 days after injury: (a) a decrease in GCS score of 2 points or more from the initial GCS score with no pharmacological sedation; (b) a deterioration in neurological status being sufficient to neurosurgical intervention.

  within 7 days after injury

Secondary Outcomes (2)

• hospital stay

  From hospitalization to discharge，up to one month

• GOSE score

  three months or six months

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All TBI patients treated at Tangdu Hospital from January 2022 to December 2022

You may qualify if:

• No systematic treatment before admission;
• The patient is diagnosed with traumatic brain injury with imaging evidence;
• Age \> 18 years old;
• The patient or family members agree to sign the informed consent.

You may not qualify if:

• Infectious diseases within the past 1 month;
• Past head trauma, history of neurological diseases;
• Non-isolated traumatic brain injury;
• The patient is not receiving treatment in this hospital;
• Severe disability, dementia, or organ dysfunction before the onset of the disease;
• Subject refuses to participate.

Sponsors & Collaborators

• Tang-Du Hospital: lead

Study Sites (1)

Tandu Hospital, Fourth Military Medical University

Xi'an, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

1. Peripheral blood was collected in a negative pressure vacuum tube and transferred to the refrigerator -80 for storage as soon as possible. 2. Peripheral blood-related cells are subsequently collected or cultured to observe the relationship between related molecules and circulating extracellular vesicles.

MeSH Terms

Conditions

Brain Injuries, Traumatic; Inflammation

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yan Qu, M.D, Ph.D

  Tang-Du Hospital

  STUDY CHAIR

• Qing Hu, M.D

  Tang-Du Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qing M Hu

CONTACT

+8615979955539; 569184879@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2022
• First Posted: March 15, 2022
• Study Start: January 25, 2022
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: March 31, 2022

Record last verified: 2022-03

Locations

CN (1)