Traumatic Brain InjuryNCT01846546
Cerebrospinal Fluid Endostatin/Collagen XVIII Concentrations in Patients With Severe Traumatic Brain Injury
An observational study of Traumatic Brain Injury, run by Shanghai 6th People's Hospital at 1 site in China.
Trial summary
Angiogenesis is an important pathophysiological response to traumatic brain injury (TBI) and modulated by pro- and anti-angiogenic factors. Recent studies have suggested that endogenous angiogenesis inhibitor endostatin/collagen XVIII might play an important role in the secondary brain injury following TBI. Read more about this study
- Who is it for?
- Ages 16 to 82 years
- Conditions the study is for
- Traumatic Brain Injury
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Oct 2006to Apr 2008
- 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 16 to 82 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Of the 30 patients with severe TBI, twenty were male and ten were female. The patients' age ranged from 16 to 82 years, with mean age of 51.1 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 with severe TBI (GCS score of 8 or less) requiring continuous lumbar drainage of CSF. Patients delivered within 4 h whose highest abbreviated injury score (AIS) was 3 or less (other than head injury) were considered to be isolated TBI cases and were included.
- Exclusion Criteria: Patients who suffered open or combined injuries, had existing prior neurological disease were excluded. Those who died within the first week of hospitalization and/or whose serial CSF samples could not be obtained were also excluded as having incomplete data.
- -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dynamic Changes of Cerebrospinal Fluid Endostatin Concentrations in Patients With Severe Traumatic Brain Injury.
Angiogenesis is an important pathophysiological response to traumatic brain injury (TBI) and modulated by pro- and anti-angiogenic factors. Recent studies have suggested that endogenous angiogenesis inhibitor endostatin/collagen XVIII might play an important role in the secondary brain injury following TBI. The aim of this study was to investigate early changes in the concentrations of CSF endostatin/collagen XVIII after TBI and evaluated the relations of endostatin/collagen XVIII to injury severity and clinical outcome. Endostatin/collagen XVIII concentrations were measured serially for 1 week after hospitalization by using the enzyme linked immunosorbent assay method in the cerebrospinal fluid of 30 patients with TBI and a Glasgow Coma Scale score of 8 or less on admission. Comparative analysis were used to determine if its serial changes correlate with the GCS score and prognosis. Receiver operating characteristic curve was used to appraise the value of CSF endostatin/collagen XVIII levels in predicting the prognosis of patients with severe head injury.
Read the detailed description
Patients with severe TBI (Glasgow Coma Scale score of 8 or less) requiring continuous lumbar drainage of CSF were included in the study. Patients delivered within 4 h whose highest abbreviated injury score was 3 or less (other than head injury) were considered to be isolated TBI cases and were included. To avoid interfering factors, patients who suffered open or combined injuries, had existing prior neurological disease were excluded. Those who died within the first week of hospitalization and/or whose serial cerebrospinal fluid samples could not be obtained were also excluded as having incomplete data. Accordingly, 30 patients were analyzed in this study. Demographic data, including age, gender, mechanism of trauma and GCS score at admission were documented when the patients arrived at the emergency room. The control group comprised 20 patients whose cerebrospinal fluid was examined via lumbar puncture for investigation of suspected neurological disease. All patients had normal neurological examination, negative imaging studies, and none had evidence of trauma or preexisting neurological disease, including tumors, vascular anomalies, or abnormalities of cerebrospinal fluid. The study had approval from the hospital ethics committee and informed consent for participating in the study was obtained from an appropriate member of each patient's family before performance of lumbar drainage.
- Conditions
- Traumatic Brain Injury
- Keywords
- Traumatic brain injury;, Endostatin/collagen XVIII;, Cerebrospinal fluid;, 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 |
|---|---|---|
| Severe Traumatic Brain Injury | Patients with severe TBI (Glasgow Coma Scale GCS score of 8 or less) requiring continuous lumbar drainage of CSF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enzyme-linked immunosorbent assay
This assay employs the quantitative sandwich enzyme immunoassay technique. In brief, a monoclonal antibody specific for endostatin/collagen XVIII had been pre-coated onto a microplate.
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 posted3 May 2013 (estimated)
- Study startOct 2006
- Primary completionOct 2007
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 30 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
- Heng-Li Tian, M.D., Ph.D., Study director, Shanghai 6th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01846546
- Sponsor's protocol ID
- ES-TBI 10JC
- Status last verified
- Sep 2020
- First submitted
- 30 Apr 2013
- Last updated
- 7 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Chen H, Xue LX, Cao HL, Chen SW, Guo Y, Gao WW, Ju SM, Tian HL. Endostatin/collagen XVIII is increased in cerebrospinal fluid after severe traumatic brain injury. Biomed Res Int. 2013;2013:402375. doi: 10.1155/2013/402375. Epub 2013 Sep 8.
PubMed 24089677
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Changes of Cerebrospinal Fluid Endostatin Concentrations in Patients With Severe Traumatic Brain Injury.
- ClinicalTrials.gov ID
- NCT01846546
- Acronym / sponsor ID
- ES-TBI 10JC
- Conditions
- Traumatic Brain Injury
- Keywords
- Traumatic brain injury;, Endostatin/collagen XVIII;, Cerebrospinal fluid;, Prognosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Shanghai 6th People's HospitalUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Oct 2007 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 3 May 2013 (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.
Angiogenesis is an important pathophysiological response to traumatic brain injury (TBI) and modulated by pro- and anti-angiogenic factors. Recent studies have suggested that endogenous angiogenesis inhibitor endostatin/collagen XVIII might play an important role in the secondary brain injury following TBI. The aim of this study was to investigate early changes in the concentrations of CSF endostatin/collagen XVIII after TBI and evaluated the relations of endostatin/collagen XVIII to injury severity and clinical outcome. Endostatin/collagen XVIII concentrations were measured serially for 1 week after hospitalization by using the enzyme linked immunosorbent assay method in the cerebrospinal fluid of 30 patients with TBI and a Glasgow Coma Scale score of 8 or less on admission. Comparative analysis were used to determine if its serial changes correlate with the GCS score and prognosis. Receiver operating characteristic curve was used to appraise the value of CSF endostatin/collagen XVIII levels in predicting the prognosis of patients with severe head injury.
Detailed description
Patients with severe TBI (Glasgow Coma Scale score of 8 or less) requiring continuous lumbar drainage of CSF were included in the study. Patients delivered within 4 h whose highest abbreviated injury score was 3 or less (other than head injury) were considered to be isolated TBI cases and were included. To avoid interfering factors, patients who suffered open or combined injuries, had existing prior neurological disease were excluded. Those who died within the first week of hospitalization and/or whose serial cerebrospinal fluid samples could not be obtained were also excluded as having incomplete data. Accordingly, 30 patients were analyzed in this study. Demographic data, including age, gender, mechanism of trauma and GCS score at admission were documented when the patients arrived at the emergency room. The control group comprised 20 patients whose cerebrospinal fluid was examined via lumbar puncture for investigation of suspected neurological disease. All patients had normal neurological examination, negative imaging studies, and none had evidence of trauma or preexisting neurological disease, including tumors, vascular anomalies, or abnormalities of cerebrospinal fluid. The study had approval from the hospital ethics committee and informed consent for participating in the study was obtained from an appropriate member of each patient's family before performance of lumbar drainage.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Severe Traumatic Brain Injury | – | –Patients with severe TBI (Glasgow Coma Scale GCS score of 8 or less) requiring continuous lumbar drainage of CSF |
Who may qualify
- Ages
- 16 to 82 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Of the 30 patients with severe TBI, twenty were male and ten were female. The patients' age ranged from 16 to 82 years, with mean age of 51.1 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 (3 listed)
- Patients with severe TBI (GCS score of 8 or less) requiring continuous lumbar drainage of CSF. Patients delivered within 4 h whose highest abbreviated injury score (AIS) was 3 or less (other than head injury) were considered to be isolated TBI cases and were included.
- Exclusion Criteria: Patients who suffered open or combined injuries, had existing prior neurological disease were excluded. Those who died within the first week of hospitalization and/or whose serial CSF samples could not be obtained were also excluded as having incomplete data.
- -
Key exclusion criteria (0 listed)
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
Enzyme-linked immunosorbent assay
Time frame: 6 months
This assay employs the quantitative sandwich enzyme immunoassay technique. In brief, a monoclonal antibody specific for endostatin/collagen XVIII had been pre-coated onto a microplate.
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 7 Sep 2020.
- Derived from this study: PubMed 24089677Chen H, Xue LX, Cao HL, Chen SW, Guo Y, Gao WW, Ju SM, Tian HL. Endostatin/collagen XVIII is increased in cerebrospinal fluid after severe traumatic brain injury. Biomed Res Int. 2013;2013:402375. doi: 10.1155/2013/402375. Epub 2013 Sep 8.
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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.
Heng-Li Tian, 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 3 inclusion and 0 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 7 Sep 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?
Enzyme-linked immunosorbent assay (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01846546, which also lists 1 linked publication.
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 7 Sep 2020.