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

March 15, 2022 updated by: Tang-Du Hospital
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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Xi'an, China
        • Recruiting
        • Tandu Hospital, Fourth Military Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The type and content of circulating extracellular vesicles
Time Frame: 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.
within 24 hours of TBI
Neurological deterioration in patients with traumatic brain injury
Time Frame: 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.
within 7 days after injury

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hospital stay
Time Frame: 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.
From hospitalization to discharge，up to one month
GOSE score
Time Frame: 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).
three months or six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tang-Du Hospital

Investigators

  • Study Chair: Yan Qu, M.D, Ph.D, Tang-Du Hospital
  • Principal Investigator: Qing Hu, M.D, Tang-Du Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 25, 2022

Primary Completion (Anticipated)

November 1, 2022

Study Completion (Anticipated)

November 1, 2022

Study Registration Dates

First Submitted

January 26, 2022

First Submitted That Met QC Criteria

March 6, 2022

First Posted (Actual)

March 15, 2022

Study Record Updates

Last Update Posted (Actual)

March 31, 2022

Last Update Submitted That Met QC Criteria

March 15, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TDSJWKTBIEX

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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