Skull Injury TraumaNCT02571023
Multicenter Clinical Study on Diagnosis and Treatment of Skull Base Trauma
An observational study of Skull Injury Trauma, run by Hou Lijun at 1 site in China.
Trial summary
The purposes of this study are as follows: 1. to collect the largest epidemiological data of skull base trauma and analyze the related influence factors of mortality and morbidity. 2. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Skull Injury Trauma
- What is being tested?
- microscope surgery and neuroendoscope surgery
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Jan 2016to Jun 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All the patients with skull base trauma in inpatient ward.
Who may be able to join
- Clinical diagnosis of Skull Base Trauma
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Neurosurgery, Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, 200003
Lijun Hou, MD, 008602181885671, 15921509289@163.com
About this study
The purposes of this study are as follows:
- to collect the largest epidemiological data of skull base trauma and analyze the related influence factors of mortality and morbidity.
- to establish a set of standard classification methods of skull base trauma and to establish a standard rating scale for each type of trauma.
- to select optimized conservative and surgical treatments of skull base trauma and to compare the therapeutic effect between microscope surgery and neuroendoscopic surgery.
- to clear the epidemiological characteristics of the skull base trauma combined with paroxysmal sympathetic hyperactivity.
- Conditions
- Skull Injury Trauma
- Being tested
- microscope surgery, neuroendoscope surgery
- Keywords
- Skull Base Trauma, microscope surgery, neuroendoscope surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
microscope surgeryProcedure or surgery
neuroendoscope surgeryProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality
Measured: 1 year
disability rate
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2015 (estimated)
- Study startJan 2016
- Primary completionJun 2018 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skull Injury TraumaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hou Lijun
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hou Lijun, Shanghai Changzheng Hospital
- Investigators
- Lijun Hou, MD, Study chair, Department of Neurosurgery, Shanghai Changzheng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02571023
- Sponsor's protocol ID
- Skull Base Trauma 2016
- Status last verified
- Oct 2015
- First submitted
- 6 Oct 2015
- Last updated
- 8 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Clinical Study on Diagnosis and Treatment of Skull Base Trauma
- ClinicalTrials.gov ID
- NCT02571023
- Acronym / sponsor ID
- Skull Base Trauma 2016
- Conditions
- Skull Injury Trauma
- Keywords
- Skull Base Trauma, microscope surgery, neuroendoscope surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Hou LijunUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 8 Oct 2015 (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.
The purposes of this study are as follows:
- to collect the largest epidemiological data of skull base trauma and analyze the related influence factors of mortality and morbidity.
- to establish a set of standard classification methods of skull base trauma and to establish a standard rating scale for each type of trauma.
- to select optimized conservative and surgical treatments of skull base trauma and to compare the therapeutic effect between microscope surgery and neuroendoscopic surgery.
- to clear the epidemiological characteristics of the skull base trauma combined with paroxysmal sympathetic hyperactivity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All the patients with skull base trauma in inpatient ward.
Key inclusion criteria (1 listed)
- Clinical diagnosis of Skull Base Trauma
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| microscope surgery | Procedure or surgery | – |
| neuroendoscope surgery | Procedure or surgery | – |
Primary outcome
mortality
Time frame: 1 year
disability rate
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2015.
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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.
Lijun Hou, MD study chair
Department of Neurosurgery, Shanghai Changzheng 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 Skull Injury Trauma, run by Hou Lijun 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 8 Oct 2015. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lijun Hou, MD (008602181885671, 15921509289@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality (time frame: 1 year). The study lists 2 primary outcomes in all. 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 8 Oct 2015.