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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02229643
Other study ID # 658346
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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