- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02229643
Serum Neuroglobin and Nogo-A Concentrations in Acute Traumatic Brain Injury
August 8, 2020 updated by: Hao Chen, Shanghai 6th People's Hospital
Neuroglobin and Nogo-A as Biomarkers for the Prognosis of Closed Traumatic Brain Injury
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
34
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Shanghai, China, 200233
- Shanghai Sixth People's Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Glasgow Outcome Scale scores
Time Frame: 6 months
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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.
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6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Lixia Xue, M.D., Ph.D., Shanghai 6th People's Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2012
Primary Completion (Actual)
June 1, 2013
Study Completion (Actual)
June 1, 2014
Study Registration Dates
First Submitted
August 21, 2014
First Submitted That Met QC Criteria
August 28, 2014
First Posted (Estimate)
September 1, 2014
Study Record Updates
Last Update Posted (Actual)
August 11, 2020
Last Update Submitted That Met QC Criteria
August 8, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 658346
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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