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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02659046
Other study ID # R15158
Secondary ID
Status Completed
Phase N/A
First received January 15, 2016
Last updated December 8, 2017
Start date December 2015
Est. completion date December 2016

Study information

Verified date December 2017
Source Tampere University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

A secondary aim is to identify out-of-hospital treatment factors that can be influenced by education and protocols.


Recruitment information / eligibility

Status Completed
Enrollment 266
Est. completion date December 2016
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- TBI with GCS = 8 or unconsciousness verified by an on-call neurosurgeon during admission to the hospital

Exclusion Criteria:

- Multiple trauma

Study Design


Locations

Country Name City State
Finland Tampere University Hospital Tampere

Sponsors (1)

Lead Sponsor Collaborator
Tampere University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mortality 1 year
Secondary Glasgow outcome score 1 year
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