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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Tampere University Hospital
ClinicalTrials.gov Identifier:
NCT01571375
First received: April 2, 2012
Last updated: December 11, 2013
Last verified: April 2012
  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 ] [ 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: June 2012
Estimated Primary Completion Date: November 2015 (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

Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 Hospital
Study Chair: Tarja Randell, PhD Helsinki University Hospital
Study Chair: Ilkka Virkkunen, PhD Tampere University Hospital
Principal Investigator: Toni Pakkanen, M.D. Tampere University
  More Information

No publications provided

Responsible Party: Tampere University Hospital
ClinicalTrials.gov Identifier: NCT01571375     History of Changes
Other Study ID Numbers: R10037
Study First Received: April 2, 2012
Last Updated: December 11, 2013
Health Authority: Finland: Ethics Committee

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

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

ClinicalTrials.gov processed this record on August 26, 2014