NCT01454648

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
458

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
6.8 years until next milestone

First Submitted

Initial submission to the registry

October 5, 2011

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 19, 2011

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

January 18, 2016

Status Verified

November 1, 2014

Enrollment Period

6.9 years

First QC Date

October 5, 2011

Last Update Submit

January 15, 2016

Conditions

Traumatic Brain Injury

Keywords

Traumatic Brain InjuryEMSOut-of-Hospital

Outcome Measures

Primary Outcomes (1)

  • Mortality

    1 year

Secondary Outcomes (1)

  • Glasgow outcome score

    1 year

Study Arms (2)

Physician-staffed

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

Paramedic-staffed

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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

primary care clinic

You may qualify if:

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

You may not qualify if:

  • Multiple trauma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tampere University Hospital

Tampere, Finland

Location

Related Publications (1)

  • Pakkanen T, Virkkunen I, Kamarainen A, Huhtala H, Silfvast T, Virta J, Randell T, Yli-Hankala A. Pre-hospital severe traumatic brain injury - comparison of outcome in paramedic versus physician staffed emergency medical services. Scand J Trauma Resusc Emerg Med. 2016 Apr 29;24:62. doi: 10.1186/s13049-016-0256-x.

    PMID: 27130216DERIVED

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Arvi Yli-Hankala, professor

    Tampere University Hospital

    STUDY DIRECTOR

  • Toni Pakkanen, M.D.

    Tampere University

    PRINCIPAL INVESTIGATOR

  • Ilkka Virkkunen, M.D., PhD

    Tampere University Hospital

    STUDY DIRECTOR

  • Tom Silfvast, M.D., PhD

    Helsinki University Central Hospital

    STUDY DIRECTOR

  • Tarja Randell, M.D., PhD

    Helsinki University Central Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2011

First Posted

October 19, 2011

Study Start

January 1, 2005

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

January 18, 2016

Record last verified: 2014-11

Locations

FI(1)