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

• Conditions: Traumatic Brain Injury

• Registration Number: NCT05279599
• Lead Sponsor: Tang-Du Hospital

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.

Detailed Description

To compare the changes of molecular markers and circulating-related cell phenotype molecules in the serum of patients with traumatic brain injury, to observe the relationship between the changes of circulating extracellular vesicles and the development and outcome of the disease in patients with traumatic brain injury, and to search for early serum markers of patients with traumatic brain injury and potential interventions.

Study Timeline

• Study Start: 2022-01-25
• Study First Submitted: 2022-01-26
• Status Verified: 2022-03
• Study First Submitted QC: 2022-03-06
• Study First Posted: 2022-03-15
• Last Update Submitted: 2022-03-15
• Last Update Posted: 2022-03-31
• Primary Completion: 2022-11-01
• Study Completion: 2022-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Neurological deterioration in patients with traumatic brain injury	within 7 days after 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.
The type and content of circulating extracellular vesicles	within 24 hours of TBI	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.

Secondary Outcome Measures

Name	Time	Method
GOSE score	three months or six months	The GOSE score was dichotomized into being moderately disabled or worse (GOSE score ≤6) versus good recovery (GOSE score 7-8), and into being severely disabled or worse (GOSE score ≤4) versus moderate or no disability (GOSE score 5-8).
hospital stay	From hospitalization to discharge，up to one month	The cumulative number of days from admission to discharge of the patient. Regardless of whether the admission and discharge were in the morning or afternoon, the total admission and discharge was one day. It mainly reflects the turnover of hospital beds.

Trial Locations

Locations (1)

Tandu Hospital, Fourth Military Medical University; 🇨🇳 Xi'an, China