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Clinical Trials/NCT03611166
NCT03611166
Unknown
Not Applicable

iTRAQ-Based Proteomics Reveals Potential Biomarkers for Chronic Disorder of Consciousness

First Affiliated Hospital of Zhejiang University1 site in 1 country200 target enrollmentNovember 1, 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Disorder of Consciousness
Sponsor
First Affiliated Hospital of Zhejiang University
Enrollment
200
Locations
1
Primary Endpoint
Protein profiling
Last Updated
7 years ago

Overview

Brief Summary

Following severe traumatic brain injury, patients may remain unconscious for many years. It is the first proteomic analysis comparing differentially expressed proteins between patients with chronic disorder of consciousness and controls so far. The investigators generated accurate lists of proteomes and identified differences at different disease time courses. The obtained results provide new insight into understanding the molecular mechanisms underlying the chronic disorder of consciousness.

Detailed Description

Background: Patients who awake from severely traumatic brain injury (sTBI) may remain unconscious for many years. Although behavioral assessment and functional imaging are currently used as diagnostic tools, the molecular basis underlying chronic condition has yet to be explored. Objective:To explore the molecular basis and identify novel biomarkers for the diagnosis and prognosis of patients with chronic disorder of consciousness. Method: Plasma samples were obtained from patients with chronic disorder of consciousness, and healthy volunteers. A coupled isobaric tag for relative and absolute quantitation (iTRAQ)-based proteomics approach was used to screen differentially expressed proteins (DEPs) between patients and controls. Potential molecular mechanisms were further discussed through bioinformatics analyses. Candidate proteins were validated by enzyme-linked immunosorbent assay (ELISA).

Registry
clinicaltrials.gov
Start Date
November 1, 2015
End Date
January 15, 2020
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
First Affiliated Hospital of Zhejiang University
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients ages 14 to 65 years old;
  • Patients had a history of sTBI;
  • Patients had awakened from a coma (indicating preserved sleep-wake cycles), including vegetative state and minimally consciousness state;
  • Patients stay unconscious for more than 1 month.

Exclusion Criteria

  • Patients with acute infectious diseases or liver dysfunction;
  • Patients with serious diseases such as cardiac or pulmonary problems.

Outcomes

Primary Outcomes

Protein profiling

Time Frame: Three months

A coupled isobaric tag for relative and absolute quantitation (iTRAQ)-based proteomics approach was used to screen differentially expressed proteins (DEPs) between patients and controls.

Secondary Outcomes

  • Glasgow Outcome Scale (GOS)(In one year)
  • Coma Recovery Scale-Revised(CRS-R)(30 minutes before blood collection)

Study Sites (1)

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