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

Traumatic Brain Injury Clinical Trial

Official title:

Neuroglobin and Nogo-A as Biomarkers for the Prognosis of Closed Traumatic Brain Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02229643
• Other study ID #: 658346
• Status: Completed
• Start date: May 2012
• Est. completion date: June 2014

Study information

• Verified date: August 2020
• Source: Shanghai 6th People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: June 2014
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury
• Wounds and Injuries

Locations

Country	Name	City	State
China	Shanghai Sixth People's Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai 6th People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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