- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02571023
Multicenter Clinical Study on Diagnosis and Treatment of Skull Base Trauma
October 7, 2015 updated by: Hou Lijun
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 Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
300
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Lijun Hou, MD
- Phone Number: 008602181885671
- Email: 15921509289@163.com
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200003
- Department of Neurosurgery, Shanghai Changzheng Hospital
-
Contact:
- Lijun Hou, MD
- Phone Number: 008602181885671
- Email: 15921509289@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All the patients with skull base trauma in inpatient ward.
Description
Inclusion Criteria:
- Clinical diagnosis of Skull Base Trauma
Exclusion Criteria:
- N/A
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
mortality
Time Frame: 1 year
|
1 year
|
disability rate
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Lijun Hou, MD, Department of Neurosurgery, Shanghai Changzheng Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2016
Primary Completion (Anticipated)
June 1, 2018
Study Completion (Anticipated)
June 1, 2018
Study Registration Dates
First Submitted
October 6, 2015
First Submitted That Met QC Criteria
October 7, 2015
First Posted (Estimate)
October 8, 2015
Study Record Updates
Last Update Posted (Estimate)
October 8, 2015
Last Update Submitted That Met QC Criteria
October 7, 2015
Last Verified
October 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Skull Base Trauma 2016
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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