Traumatic Brain InjuryNCT02659046
Prehospital Severe 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. In the second part of the study the gathered data will be combined with the data from an earlier study (NCT01454648) for regression analysis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Traumatic Brain Injury
- How many people
- 266 participants
- Where
- 1 siteFinland
- Study dates
- Dec 2015to Dec 2016
- 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: The Effect of Different Emergency Medical Systems on the Prognosis of Traumatic Brain Injury
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.
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
- 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 |
|---|---|---|
| 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 |
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 posted20 Jan 2016 (estimated)
- Study startDec 2015
- Primary completionDec 2016
- Study completionDec 2016
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
- 266 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 Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02659046
- Sponsor's protocol ID
- R15158
- Status last verified
- Dec 2017
- First submitted
- 15 Jan 2016
- Last updated
- 11 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 28915898
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Emergency Medical Systems on the Prognosis of Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT02659046
- Acronym / sponsor ID
- R15158
- Conditions
- Traumatic Brain Injury
- Keywords
- Traumatic Brain Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 266 participants (actual)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Study start
- Dec 2015 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 20 Jan 2016 (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.
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.
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 |
|---|---|---|
| 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 |
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 11 Dec 2017.
- Derived from this study: PubMed 28915898Pakkanen 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.
- Individual participant dataSharing planned: No
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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
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 11 Dec 2017. 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 NCT02659046, 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 11 Dec 2017.