NCT01571375

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. 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.

Trial Health

33
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
suspended

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

First Submitted

Initial submission to the registry

April 2, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 5, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
8.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

September 23, 2019

Status Verified

August 1, 2019

Enrollment Period

8.4 years

First QC Date

April 2, 2012

Last Update Submit

September 20, 2019

Conditions

Traumatic Brain Injury

Keywords

Traumatic Brain InjuryHEMSOut-of-hospitalFinland

Outcome Measures

Primary Outcomes (1)

  • Mortality

    1 year

Secondary Outcomes (1)

  • Glasgow Outcome Score

    1 year

Study Arms (2)

FinnHEMS10

Patients Treated by Helsinki HEMS.

FinnHEMS30

PAtients Treated by Tampere HEMS.

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 CGS \< 9 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

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

  • Tom Silfvast, PhD

    Helsinki University Central Hospital

    STUDY DIRECTOR

  • Tarja Randell, PhD

    Helsinki University Central Hospital

    STUDY CHAIR

  • Ilkka Virkkunen, PhD

    Tampere University Hospital

    STUDY CHAIR

  • Toni Pakkanen, M.D.

    Tampere University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 2, 2012

First Posted

April 5, 2012

Study Start

June 1, 2012

Primary Completion

November 1, 2020

Study Completion

December 1, 2020

Last Updated

September 23, 2019

Record last verified: 2019-08

Locations

FI(1)