Prehospital Severe Traumatic Brain Injury

December 8, 2017 updated by: Tampere University Hospital

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

Completed

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

266

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Tampere, Finland
        • Tampere University Hospital

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

primary care clinic

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

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

Cohorts and Interventions

Group / Cohort
FH30
Patients treated by Pirkanmaa physician-staffed emergency medical service (EMS) unit
FH10
Patients treated by Helsinki and Uusimaa physician-staffed emergency medical service (EMS) unit

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

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Arvi Yli-Hankala, Professor, Tampere University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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 (Actual)

December 1, 2015

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

January 15, 2016

First Submitted That Met QC Criteria

January 15, 2016

First Posted (Estimate)

January 20, 2016

Study Record Updates

Last Update Posted (Actual)

December 11, 2017

Last Update Submitted That Met QC Criteria

December 8, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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