Traumatic Brain Injury Clinical Trial
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
| NCT number | NCT01571375 |
| Other study ID # | R10037 |
| Secondary ID | |
| Status | Suspended |
| Phase | |
| First received | |
| Last updated | |
| Start date | June 2012 |
| Est. completion date | December 2020 |
| Verified date | August 2019 |
| Source | Tampere University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Suspended |
| Enrollment | 400 |
| Est. completion date | December 2020 |
| Est. primary completion date | November 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: - TBI with CGS < 9 or unconsciousness verified by an on-call neurosurgeon during admission to the hospital. Exclusion Criteria: - Multiple trauma |
| Country | Name | City | State |
|---|---|---|---|
| Finland | Tampere University Hospital | Tampere |
| Lead Sponsor | Collaborator |
|---|---|
| Tampere University Hospital |
Finland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Mortality | 1 year | ||
| Secondary | Glasgow Outcome Score | 1 year |
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