NCT02659046

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
266

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2015

Shorter than P25 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

December 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 20, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

December 11, 2017

Status Verified

December 1, 2017

Enrollment Period

1 year

First QC Date

January 15, 2016

Last Update Submit

December 8, 2017

Conditions

Traumatic Brain Injury

Keywords

Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

  • Mortality

    1 year

Secondary Outcomes (1)

  • Glasgow outcome score

    1 year

Study Arms (2)

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

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, Kamarainen A, Huhtala H, Silfvast T, Nurmi J, Virkkunen I, Yli-Hankala A. Physician-staffed helicopter emergency medical service has a beneficial impact on the incidence of prehospital hypoxia and secured airways on patients with severe traumatic brain injury. Scand J Trauma Resusc Emerg Med. 2017 Sep 15;25(1):94. doi: 10.1186/s13049-017-0438-1.

    PMID: 28915898DERIVED

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

Study Design

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

Study Record Dates

First Submitted

January 15, 2016

First Posted

January 20, 2016

Study Start

December 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

December 11, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)