Traumatic Brain InjuryNCT01571375
The Effect of Different Emergency Medical Systems on the Prognosis of Traumatic Brain Injury - a Prospective Study
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. Physician-staffed HEMS unit was implemented to the EMS 2011. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Traumatic Brain Injury
- How many people
- 400 participants
- Where
- 1 siteFinland
- Study dates
- Jun 2012to Dec 2020
- 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 CGS < 9 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 Differences Between Out-of-hospital Severe Traumatic Brain Injury (TBI) Treatment in a Physician-staffed Versus Paramedic-staffed Emergency Medical Service (EMS) Unit and Its Effect on Patient Prognosis
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.
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, HEMS, Out-of-hospital, Finland
- 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 |
|---|---|---|
| FinnHEMS10 | Patients Treated by Helsinki HEMS. | |
| FinnHEMS30 | PAtients Treated by Tampere HEMS. |
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 posted5 Apr 2012 (estimated)
- Study startJun 2012
- Primary completionNov 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prospective
- Enrolment
- 400 participants (estimated)
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 HospitalTom Silfvast, PhD, Study director, Helsinki University Central HospitalTarja Randell, PhD, Study chair, Helsinki University Central HospitalIlkka Virkkunen, PhD, Study chair, Tampere University HospitalToni Pakkanen, M.D., Principal investigator, Tampere University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01571375
- Sponsor's protocol ID
- R10037
- Status last verified
- Aug 2019
- First submitted
- 2 Apr 2012
- Last updated
- 23 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Differences Between Out-of-hospital Severe Traumatic Brain Injury (TBI) Treatment in a Physician-staffed Versus Paramedic-staffed Emergency Medical Service (EMS) Unit and Its Effect on Patient Prognosis
- ClinicalTrials.gov ID
- NCT01571375
- Acronym / sponsor ID
- R10037
- Conditions
- Traumatic Brain Injury
- Keywords
- Traumatic Brain Injury, HEMS, Out-of-hospital, Finland
- Study type
- Observational
- Recruitment status
- Suspended
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Nov 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 5 Apr 2012 (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.
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.
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
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FinnHEMS10 | – | –Patients Treated by Helsinki HEMS. |
| FinnHEMS30 | – | –PAtients Treated by Tampere HEMS. |
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 CGS < 9 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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2019.
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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
Tom Silfvast, PhD study director
Helsinki University Central Hospital
Tarja Randell, PhD study chair
Helsinki University Central 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: paused, as of the sponsor's last update on 23 Sep 2019. 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?
Results are not available in the source record.
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?
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 23 Sep 2019.