Traumatic Brain InjuryNCT01454648
Prehospital Traumatic Brain Injury
An observational study of Traumatic Brain Injury, run by Tampere University Hospital at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Traumatic Brain Injury
- How many people
- 458 participants
- Where
- 1 siteFinland
- Study dates
- Jan 2005to Dec 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: primary care clinic
Who may be able to join
- TBI with GCS ≤ 8 or unconsciousness verified by an on-call neurosurgeon during admission to the hospital.
Who cannot join
- Multiple trauma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Severe Traumatic Brain Injury - Comparison of Outcome in Paramedic Versus Physician Staffed Emergency Medical Services
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.
Read the detailed description
A secondary aim is to identify out-of-hospital treatment factors that can be influenced by education and protocols.
- Conditions
- Traumatic Brain Injury
- Keywords
- Traumatic Brain Injury, EMS, Out-of-Hospital
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Physician-staffed | Patients treated by physician-staffed emergency medical service (EMS) unit | |
| Paramedic-staffed | Patients treated by paramedic-staffed emergency medical service (EMS) unit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Measured: 1 year
Secondary outcomes (1)
Glasgow outcome score
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2011 (estimated)
- Study startJan 2005
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Tampere University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 458 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arvi Yli-Hankala, professor, Study director, Tampere University HospitalToni Pakkanen, M.D., Principal investigator, Tampere UniversityIlkka Virkkunen, M.D., PhD, Study director, Tampere University HospitalTom Silfvast, M.D., PhD, Study director, Helsinki University Central HospitalTarja Randell, M.D., PhD, Study chair, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01454648
- Sponsor's protocol ID
- R09161
- Status last verified
- Nov 2014
- First submitted
- 5 Oct 2011
- Last updated
- 18 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27130216
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Severe Traumatic Brain Injury - Comparison of Outcome in Paramedic Versus Physician Staffed Emergency Medical Services
- ClinicalTrials.gov ID
- NCT01454648
- Acronym / sponsor ID
- R09161
- Conditions
- Traumatic Brain Injury
- Keywords
- Traumatic Brain Injury, EMS, Out-of-Hospital
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 458 participants (actual)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 19 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A secondary aim is to identify out-of-hospital treatment factors that can be influenced by education and protocols.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physician-staffed | – | –Patients treated by physician-staffed emergency medical service (EMS) unit |
| Paramedic-staffed | – | –Patients treated by paramedic-staffed emergency medical service (EMS) unit |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- primary care clinic
Key inclusion criteria (1 listed)
- TBI with GCS ≤ 8 or unconsciousness verified by an on-call neurosurgeon during admission to the hospital.
Key exclusion criteria (1 listed)
- Multiple trauma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality
Time frame: 1 year
1 secondary outcome
Glasgow outcome score
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2016.
- Derived from this study: PubMed 27130216Pakkanen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arvi Yli-Hankala, professor study director
Tampere University Hospital
Toni Pakkanen, M.D. principal investigator
Tampere University
Ilkka Virkkunen, M.D., PhD study director
Tampere University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury, run by Tampere University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01454648, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2016.