- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02418169
Association Between Craniofacial Fractures and Brain Injuries: Diagnostic and Therapeutic Considerations
Study Overview
Status
Conditions
Detailed Description
A part of mild TBIs remains undiagnosed. Therefore the primary diagnostics of trauma patients needs to be improved. According to some studies, a part of trauma patients' concomitant injuries weren't diagnosed in the emergency room (ER) but were diagnosed later in the clinics. In addition to difficult diagnostics the treatment of these patients demands close co- operation between many specialities.
The aim of this study is to evaluate the association between TBIs and facial fractures. The real amount of facial fractures in patients with severe TBI and the clinical significance of these fractures are evaluated. Also the number of patients with facial fractures and a concomitant TBI is evaluated. The aim is to find out the amount of patients with missed diagnoses. Other aims of are to determine the effect of the type or location of a facial fracture on the in- cidence and severity of TBI. With the help of the results it would be possible to improve the comprehensive diagnostics and early treatment of patients with a facial fracture or a TBI.
The retrospective and prospective data on patients with TBI and/or facial fracture are collect- ed at Turku University Hospital. The comparison of the two groups will give information on the amount of patients with missed diagnosis of TBI or facial fracture. The results can be utilised in planning strategy for comprehensive diagnostics and treatment of the patients. In the research group the investigators have specialists in the fields of oral and maxillofacial surgery, neurol- ogy and otorhinolaryngology.
Study Type
Enrollment (Anticipated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Severe traumatic brain injury, GCS 8 or less and/or Craniofacial fracture
Exclusion Criteria:
- Died before admitted to hospital
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
retrospective, severe traumatic brain injury
All patients in 2010-2014 with severe traumatic brain injury admitted to Turku University Central Hospital (TUCH)
|
retrospective, craniofacial fracture
All patients in 2010-2014 with craniofacial fracture admitted to TUCH.
|
prospective, severe traumatic brain injury
All patients in 2015-2017 with severe traumatic brain injury admitted to Turku University Central Hospital (TUCH)
|
prospective, craniofacial fracture
All patients in 2015-2017 with craniofacial fracture admitted to TUCH.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
survival
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- T74/2015
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