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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05279599
Enrollment
300
Registered
2022-03-15
Start date
2022-01-25
Completion date
2022-11-01
Last updated
2022-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic Brain Injury

Keywords

molecular markers, prognosis, inflammation, peripheral circulation

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.

Interventions

None listed

Sponsors

Tang-Du Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
The type and content of circulating extracellular vesicleswithin 24 hours of TBIAfter 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.
Neurological deterioration in patients with traumatic brain injurywithin 7 days after injuryNeurological 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.

Secondary

MeasureTime frameDescription
hospital stayFrom hospitalization to discharge,up to one monthThe 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.
GOSE scorethree months or six monthsThe 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).

Countries

China

Contacts

Primary ContactQing M Hu
569184879@qq.com+8615979955539

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026