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Prehospital Severe 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.
 
ClinicalTrials.gov Identifier: NCT02659046
Recruitment Status : Completed
First Posted : January 20, 2016
Last Update Posted : December 11, 2017
Sponsor:
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.

In the second part of the study the gathered data will be combined with the data from an earlier study (NCT01454648) for regression analysis. The aim of the second study is to identify prehospital factors influencing the prognosis of prehospital 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.

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Study Type : Observational
Actual Enrollment : 266 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: The Effect of Different Emergency Medical Systems on the Prognosis of Traumatic Brain Injury
Actual Study Start Date : December 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Group/Cohort
FH30
Patients treated by Pirkanmaa physician-staffed emergency medical service (EMS) unit
FH10
Patients treated by Helsinki and Uusimaa physician-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, Older Adult
Sexes Eligible for Study:   All
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

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): NCT02659046


Locations
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Finland
Tampere University Hospital
Tampere, Finland
Sponsors and Collaborators
Tampere University Hospital
Investigators
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Study Director: Arvi Yli-Hankala, Professor Tampere University Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Tampere University Hospital
ClinicalTrials.gov Identifier: NCT02659046    
Other Study ID Numbers: R15158
First Posted: January 20, 2016    Key Record Dates
Last Update Posted: December 11, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Tampere University Hospital:
Traumatic Brain Injury
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System