- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02659046
Prehospital Severe Traumatic Brain Injury
The Effect of Different Emergency Medical Systems on the Prognosis of Traumatic Brain Injury
The aim of the study is to measure the effect of Finnish physician-staffed EMS unit treatment methods on traumatic brain injury (TBI) patient prognosis.
In the second part of the study the gathered data will be combined with the data from an earlier study (NCT01454648) for regression analysis. The aim of the second study is to identify prehospital factors influencing the prognosis of prehospital TBI patients.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Tampere, Finland
- Tampere University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- TBI with GCS ≤ 8 or unconsciousness verified by an on-call neurosurgeon during admission to the hospital
Exclusion Criteria:
- Multiple trauma
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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FH30
Patients treated by Pirkanmaa physician-staffed emergency medical service (EMS) unit
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FH10
Patients treated by Helsinki and Uusimaa physician-staffed emergency medical service (EMS) unit
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mortality
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Glasgow outcome score
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Arvi Yli-Hankala, Professor, Tampere University Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R15158
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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