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

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ClinicalTrials.gov Identifier: NCT01571375
Recruitment Status : Suspended
First Posted : April 5, 2012
Last Update Posted : February 27, 2018
Information provided by (Responsible Party):
Tampere University Hospital

Brief 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.

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 or disease
Traumatic Brain Injury

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

Study Type : Observational
Estimated Enrollment : 400 participants
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
Study Start Date : June 2012
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Patients Treated by Helsinki HEMS.
PAtients Treated by Tampere HEMS.

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

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

Information from the National Library of Medicine

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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

Inclusion Criteria:

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

Exclusion Criteria:

  • Multiple trauma

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

Tampere University Hospital
Tampere, Finland
Sponsors and Collaborators
Tampere University Hospital
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

Responsible Party: Tampere University Hospital
ClinicalTrials.gov Identifier: NCT01571375     History of Changes
Other Study ID Numbers: R10037
First Posted: April 5, 2012    Key Record Dates
Last Update Posted: February 27, 2018
Last Verified: February 2018

Keywords provided by Tampere University Hospital:
Traumatic Brain Injury

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