Traumatic Brain InjuryNCT02229643
Serum Neuroglobin and Nogo-A Concentrations in Acute Traumatic Brain Injury
An observational study of Traumatic Brain Injury, run by Shanghai 6th People's Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Traumatic Brain Injury
- How many people
- 34 participants
- Where
- 1 siteChina
- Study dates
- May 2012to Jun 2014
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Traumatic Brain Injury
- Keywords
- Traumatic brain injury, Neuroglobin, Nogo-A, Prognosis
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2014 (estimated)
- Study startMay 2012
- Primary completionJun 2013
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Shanghai 6th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hao Chen, Shanghai 6th People's Hospital
- Investigators
- Lixia Xue, M.D., Ph.D., Study director, Shanghai 6th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02229643
- Sponsor's protocol ID
- 658346
- Status last verified
- Aug 2020
- First submitted
- 21 Aug 2014
- Last updated
- 11 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroglobin and Nogo-A as Biomarkers for the Prognosis of Closed Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT02229643
- Acronym / sponsor ID
- 658346
- Conditions
- Traumatic Brain Injury
- Keywords
- Traumatic brain injury, Neuroglobin, Nogo-A, Prognosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Shanghai 6th People's HospitalUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 1 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lixia Xue, M.D., Ph.D. study director
Shanghai 6th People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury, run by Shanghai 6th People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glasgow Outcome Scale scores (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2020.