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

Traumatic Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05279599
• Other study ID #: TDSJWKTBIEX
• Status: Recruiting
• Start date: January 25, 2022
• Est. completion date: November 1, 2022

Study information

• Verified date: March 2022
• Source: Tang-Du Hospital
• Contact: Qing M Hu
• Phone: +8615979955539
• Email: 569184879[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: November 1, 2022
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury
• Wounds and Injuries

Locations

Country	Name	City	State
China	Tandu Hospital, Fourth Military Medical University	Xi'an

Sponsors (1)

Lead Sponsor	Collaborator
Tang-Du Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	From hospitalization to discharge,up to one month
Secondary	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).	three months or six months