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Status unknownNCT05279599Updated Mar 31, 2022

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

An observational study in Traumatic Brain Injury, sponsored by Tang-Du Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-31.

Sponsored by Tang-Du Hospital · Observational

The sponsor has not verified this record recently (last verified Mar 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
18 Years to 80 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Traumatic Brain Injury

Keywords

  • molecular markers
  • prognosis
  • inflammation
  • peripheral circulation
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In context

Brain Injuries

2,114 studies on the registry are indexed under Brain Injuries; 386 are open to participants now.

This study's planned enrollment of 300 is above the median of 100 across 690 observational studies indexed under Brain Injuries.

Browse Brain Injuries studies →

Lead sponsor

Tang-Du Hospital is the lead sponsor of 164 studies on the registry; 77 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

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

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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna
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What researchers measure

Primary outcomes

  1. 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.

    Time frame: within 24 hours of TBI

  2. 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.

    Time frame: within 7 days after injury

Secondary outcomes

  1. hospital stay

    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.

    Time frame: From hospitalization to discharge,up to one month

  2. GOSE score

    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).

    Time frame: three months or six months

07

Study locations

1 of 1 sites recruiting
  • Tandu Hospital, Fourth Military Medical University
    Xi'an, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 31, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05279599
Lead sponsor
Tang-Du Hospital
Responsible party
Sponsor
First posted
Mar 15, 2022
Start date
Jan 25, 2022
Primary completion
Nov 1, 2022 (estimated)
Completion
Nov 1, 2022 (estimated)
Last update
Mar 31, 2022

Study contacts

Qing M Hu
Contact
569184879@qq.com
+8615979955539
Yan Qu, M.D, Ph.D
study chair · Tang-Du Hospital
Qing Hu, M.D
principal investigator · Tang-Du Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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