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

This study has suspended participant recruitment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01571375
First Posted: April 5, 2012
Last Update Posted: October 21, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Tampere University Hospital
  Purpose

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.


Condition
Traumatic Brain Injury

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Tampere University Hospital:

Primary Outcome Measures:
  • Mortality [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • Glasgow Outcome Score [ Time Frame: 1 year ]

Estimated Enrollment: 400
Study Start Date: June 2012
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: November 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts
FinnHEMS10
Patients Treated by Helsinki HEMS.
FinnHEMS30
PAtients Treated by Tampere HEMS.

Detailed Description:
A Secondary Aim is to Identify Out-of-hospital Treatment Factors That Can be Influenced by Education and Protocols.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary Care Clinic
Criteria

Inclusion Criteria:

  • TBI with CGS < 9 or unconsciousness verified by an on-call neurosurgeon during admission to the hospital.

Exclusion Criteria:

  • Multiple trauma
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01571375


Locations
Finland
Tampere University Hospital
Tampere, Finland
Sponsors and Collaborators
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
  More Information

Responsible Party: Tampere University Hospital
ClinicalTrials.gov Identifier: NCT01571375     History of Changes
Other Study ID Numbers: R10037
First Submitted: April 2, 2012
First Posted: April 5, 2012
Last Update Posted: October 21, 2016
Last Verified: October 2016

Keywords provided by Tampere University Hospital:
Traumatic Brain Injury
HEMS
Out-of-hospital
Finland

Additional relevant MeSH terms:
Wounds and Injuries
Emergencies
Brain Injuries
Disease Attributes
Pathologic Processes
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System


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