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Trial record 17 of 2315 for:    brain injury

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02229643
First Posted: September 1, 2014
Last Update Posted: August 16, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hao Chen, Shanghai 6th People's Hospital
  Purpose
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.

Condition
Traumatic Brain Injury

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Neuroglobin and Nogo-A as Biomarkers for the Prognosis of Closed Traumatic Brain Injury

Resource links provided by NLM:


Further study details as provided by Hao Chen, Shanghai 6th People's Hospital:

Primary Outcome Measures:
  • Glasgow Outcome Scale scores [ Time Frame: 6 months ]
    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.


Biospecimen Retention:   Samples Without DNA
Serum samples

Enrollment: 34
Study Start Date: May 2012
Study Completion Date: June 2014
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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Ages Eligible for Study:   19 Years to 68 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02229643


Locations
China
Shanghai Sixth People's Hospital
Shanghai, China
Sponsors and Collaborators
Shanghai 6th People's Hospital
  More Information

Responsible Party: Hao Chen, Doctor, Shanghai 6th People's Hospital
ClinicalTrials.gov Identifier: NCT02229643     History of Changes
Other Study ID Numbers: 658346
First Submitted: August 21, 2014
First Posted: September 1, 2014
Last Update Posted: August 16, 2016
Last Verified: August 2016

Keywords provided by Hao Chen, Shanghai 6th People's Hospital:
Traumatic brain injury
Neuroglobin
Nogo-A
Prognosis

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System