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

15. mars 2022 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Traumatisk hjerneskade

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Forventet)

300

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Navn: Qing M Hu
Telefonnummer: +8615979955539
E-post: 569184879@qq.com

Studiesteder

Kina
- - Xi'an, Kina
    - Rekruttering
    - Tandu Hospital, Fourth Military Medical University
    - Ta kontakt med:
      
      Qing Hu, M.D
      
      Telefonnummer: 86-15979955539
      
      E-post: 569184879@qq.com

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 80 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Beskrivelse

Inclusion Criteria:

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

Exclusion Criteria:

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
The type and content of circulating extracellular vesicles Tidsramme: 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 Tidsramme: 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

Sekundære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
hospital stay Tidsramme: 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 Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Tang-Du Hospital

Etterforskere

Studiestol: Yan Qu, M.D, Ph.D, Tang-Du Hospital
Hovedetterforsker: Qing Hu, M.D, Tang-Du Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

25. januar 2022

Primær fullføring (Forventet)

1. november 2022

Studiet fullført (Forventet)

1. november 2022

Datoer for studieregistrering

Først innsendt

26. januar 2022

Først innsendt som oppfylte QC-kriteriene

6. mars 2022

Først lagt ut (Faktiske)

15. mars 2022

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

31. mars 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene