Trial record 19 of 2007 for:
Serum Neuroglobin and Nogo-A Concentrations in Acute Traumatic Brain Injury
This study has been completed.
Information provided by (Responsible Party):
Hao Chen, Shanghai 6th People's Hospital
First received: August 21, 2014
Last updated: August 31, 2014
Last verified: August 2014
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.
||Observational Model: Case-Only
Time Perspective: Prospective
|Target Follow-Up Duration:
||Neuroglobin and Nogo-A as Biomarkers for the Prognosis of Closed Traumatic Brain Injury
Biospecimen Retention: Samples Without DNA
Primary Outcome Measures:
- Glasgow Outcome Scale scores [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
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.
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||June 2013 (Final data collection date for primary outcome measure)
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.
|Ages Eligible for Study:
||19 Years to 68 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
The patient group comprised 19 male and 15 female. Their age averaged 40 years and 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.
- 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
- Patients who suffered open or combined 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
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No publications provided
||Hao Chen, Doctor, Shanghai 6th People's Hospital
History of Changes
|Other Study ID Numbers:
|Study First Received:
||August 21, 2014
||August 31, 2014
||China: Science and Technology Commission of Shanghai Municipality
Keywords provided by Shanghai 6th People's Hospital:
Traumatic brain injury
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on June 28, 2015
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries