Prehospital Traumatic Brain Injury

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. Identifier: NCT01454648
Recruitment Status : Completed
First Posted : October 19, 2011
Last Update Posted : January 18, 2016
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.

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
Actual Enrollment : 458 participants
Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Severe Traumatic Brain Injury - Comparison of Outcome in Paramedic Versus Physician Staffed Emergency Medical Services
Study Start Date : January 2005
Primary Completion Date : December 2011
Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Patients treated by physician-staffed emergency medical service (EMS) unit
Patients treated by paramedic-staffed emergency medical service (EMS) unit

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 GCS ≤ 8 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 identifier (NCT number): NCT01454648

Tampere University Hospital
Tampere, Finland
Sponsors and Collaborators
Tampere University Hospital
Study Director: Arvi Yli-Hankala, professor Tampere University Hospital
Principal Investigator: Toni Pakkanen, M.D. Tampere university
Study Director: Ilkka Virkkunen, M.D., PhD Tampere University Hospital
Study Director: Tom Silfvast, M.D., PhD Helsinki University Central Hospital
Study Chair: Tarja Randell, M.D., PhD Helsinki University Central Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Tampere University Hospital Identifier: NCT01454648     History of Changes
Other Study ID Numbers: R09161
First Posted: October 19, 2011    Key Record Dates
Last Update Posted: January 18, 2016
Last Verified: November 2014

Keywords provided by Tampere University Hospital:
Traumatic Brain Injury

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