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

This study is currently recruiting participants.
Verified March 2013 by Tampere University Hospital
Sponsor:
Information provided by (Responsible Party):
Tampere University Hospital
ClinicalTrials.gov Identifier:
NCT01454648
First received: October 5, 2011
Last updated: March 23, 2013
Last verified: March 2013
History of Changes
  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.


Condition
Traumatic Brain Injury

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: The Effect of Different Emergency Medical Systems on the Prognosis of Traumatic Brain Injury

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Tampere University Hospital:

Primary Outcome Measures:
  • Mortality [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Glasgow outcome score [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: September 2011
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Physician-staffed
Patients treated by physician-staffed emergency medical service (EMS) unit
Paramedic-staffed
Patients treated by paramedic-staffed emergency medical service (EMS) unit

Detailed Description:

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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

primary care clinic

Criteria

Inclusion Criteria:

  • TBI with GCS ≤ 8 or unconsciousness verified by an on-call neurosurgeon during admission to the hospital.

Exclusion Criteria:

  • Multiple trauma
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01454648

Locations
Finland
Tampere University Hospital Recruiting
Tampere, Finland
Contact: Ilkka Virkkunen, PhD         ilkka.virkkunen@pshp.fi    
Contact: Toni Pakkanen, MD         toni.pakkanen@fimnet.fi    
Principal Investigator: Toni Pakkanen, MD            
Sponsors and Collaborators
Tampere University Hospital
Investigators
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 hospital
Study Chair: Tarja Randell, M.D., PhD Helsinki university hospital
  More Information

No publications provided

Responsible Party: Tampere University Hospital
ClinicalTrials.gov Identifier: NCT01454648     History of Changes
Other Study ID Numbers: R09161
Study First Received: October 5, 2011
Last Updated: March 23, 2013
Health Authority: Finland: Ethics Committee

Keywords provided by Tampere University Hospital:
Traumatic Brain Injury
EMS
Out-of-Hospital

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

ClinicalTrials.gov processed this record on May 19, 2013