Serum Neuroglobin and Nogo-A Concentrations in Acute Traumatic Brain Injury

NCT02229643 | Completed

• 1 other identifier: 658346
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Neuroglobin has been described as a marker of traumatic brain injury. Nogo-A plays an important role in mediating neuroanatomical plasticity and functional recovery following traumatic brain injury. The investigators sought to examine the changes in serum neuroglobin and Nogo-A concentrations in patients with traumatic brain injury during the initial 96-h posttraumatic period and assessed the relation of neuroglobin and Nogo-A to Glasgow Coma Score and prognosis of such patients with traumatic brain injury.

Conditions

Traumatic Brain Injury

Keywords

Traumatic brain injury; Neuroglobin; Nogo-A; Prognosis

Outcome Measures

Primary Outcomes (1)

• Glasgow Outcome Scale scores

  Glasgow Outcome Scale 1 = death; Glasgow Outcome Scale 2 = vegetative state; Glasgow Outcome Scale 3 = severe neurological deficit; Glasgow Outcome Scale 4 = mild neurological deficit and Glasgow Outcome Scale 5 = premorbid level of functioning or completely recovery. Unfavorable outcome was defined as a Glasgow Outcome Scale score of ≤ 3, and favorable outcome was defined as a Glasgow Outcome Scale score of \> 3.

  6 months

Study Arms (1)

Traumatic brain injury

Patients delivered within 4 h whose highest abbreviated injury score (AIS) was 3 or less (other than head injury) were considered to be isolated traumatic brain injury cases and were included in this study.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The patient group comprised 21 male and 13 female. Their age ranged from 19 to 68 years, with mean age of 45.1 years. The mechanisms of trauma included motor vehicle collisions, falls, heavy strikes (patients who were hit by heavy objects such as bricks, sticks, or falling objects) and assaults. Types of lesions, as evidenced by radiologic and neurologic symptoms or signs, included cerebral contusions/lacerations, intracranial hematomas, brain stem injury and diffuse axonal injury.

You may qualify if:

• Patients who suffered head trauma and whose highest abbreviated injury score (AIS) was 3 or less (other than head injury)
• Patients who delivered to hospital within 4 h

You may not qualify if:

• Patients who suffered open injuries
• Patients who had existing prior neurological disease
• Patients whose serial serum samples could not be obtained
• Patients less than 18 years of age
• Patients who suffered severe life-threatening injury to organs other than the brain

Sponsors & Collaborators

• Shanghai 6th People's Hospital: lead

Study Sites (1)

Shanghai Sixth People's Hospital

Shanghai, 200233, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum samples

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Lixia Xue, M.D., Ph.D.

  Shanghai 6th People's Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: August 21, 2014
• First Posted: September 1, 2014
• Study Start: May 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2014
• Last Updated: August 11, 2020

Record last verified: 2020-08

Locations

CN (1)