Proteomics for Chronic Disorder of Consciousness

NCT03611166 | Unknown DMC

• 1 other identifier: proteomics
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Disorder of Consciousness

Keywords

proteomics; plasma; chronic disorder of consciousness

Outcome Measures

Primary Outcomes (1)

• Protein profiling

  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.

  Three months

Secondary Outcomes (2)

• Glasgow Outcome Scale (GOS)

  In one year

• Coma Recovery Scale-Revised(CRS-R)

  30 minutes before blood collection

Eligibility Criteria

• Age: 14 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic disorder of consciousness were recruited at the rehabilitation units of Hangzhou Wujing Hospital (Hangzhou, Zhejiang, China).

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead

Study Sites (1)

Hangzhou Hospital of Zhejiang CAPR

Hangzhou, Zhejiang, 310001, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Peripheral blood (5 mL) was collected in a Vacutainer® tube, containing anticoagulant, using standardized phlebotomy procedures. Plasma was prepared by centrifugation (2,000 g, 5 min, 4°C) and stored at -80°C until further analysis.

MeSH Terms

Conditions

Consciousness Disorders

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Benyan Luo, PHD

  Department of Neurology and Brain Medical Centre The First Affiliated Hospital, School of Medicine, Zhejiang University 79 Qingchun Road, Hangzhou

  PRINCIPAL INVESTIGATOR

• Jian Gao

  Hangzhou Hospital of Zhejiang CAPR,Hangzhou, Zhejiang, China

  PRINCIPAL INVESTIGATOR

• Hai Zou

  Department of Cardiology, Zhejiang Provincial People's Hospital, Hangzhou, PR China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wangxiao Bao, PHD

CONTACT

(86)15057137653; baowangxiao@zju.edu.cn

Fangping He, PHD

CONTACT

(86)13819114225; hefangping@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2018
• First Posted: August 2, 2018
• Study Start: November 1, 2015
• Primary Completion: June 15, 2019
• Study Completion: January 15, 2020
• Last Updated: August 2, 2018

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)