The Effect of Different Emergency Medical Systems on the Prognosis of Traumatic Brain Injury - a Prospective Study

September 20, 2019 updated by: Tampere University Hospital

The Differences Between Out-of-hospital Severe Traumatic Brain Injury (TBI) Treatment in a Physician-staffed Versus Paramedic-staffed Emergency Medical Service (EMS) Unit and Its Effect on Patient Prognosis

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.

Physician-staffed HEMS unit was implemented to the EMS 2011. The aim of this study is to compare the results against a historical database to see if the implementation of a HEMS unit will improve the prognosis of TBI patients.

Study Overview

Status

Suspended

Conditions

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 (Anticipated)

400

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

  • Finland
      • 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 CGS < 9 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
FinnHEMS10
Patients Treated by Helsinki HEMS.
FinnHEMS30
PAtients Treated by Tampere HEMS.

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.

Sponsor

Tampere University Hospital

Investigators

  • Study Director: Arvi Yli-Hankala, Professor, Tampere University Hospital
  • Study Director: Tom Silfvast, PhD, Helsinki University Central Hospital
  • Study Chair: Tarja Randell, PhD, Helsinki University Central Hospital
  • Study Chair: Ilkka Virkkunen, PhD, Tampere University Hospital
  • Principal Investigator: Toni Pakkanen, M.D., Tampere University

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

June 1, 2012

Primary Completion (Anticipated)

November 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

April 2, 2012

First Submitted That Met QC Criteria

April 2, 2012

First Posted (Estimate)

April 5, 2012

Study Record Updates

Last Update Posted (Actual)

September 23, 2019

Last Update Submitted That Met QC Criteria

September 20, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R10037

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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