Multiple TraumaNCT00204204
Importance of Forces and Safety Features in Car Crash Multitrauma
An observational study of Multiple Trauma, run by University of Oslo at 1 site in Norway.
Trial summary
The pupose of the study is a prospective evaluation of external and internal factors/causes of importance for the trauma and final outcome experienced by persons inside motor vehicles in serious car accidents. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Multiple Trauma
- How many people
- 200 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2005to Jan 2006
- 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
Who may be able to join
- patients with multiple trauma from severe motor vehicle accidents in Eastern Norway patients from motor vehicle accidents in Eastern Norway with severe material damage
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Multitraumatized Patient. What is the Importance of Forces Involved and the Use of Safety Equipment for the Amount of Trauma to the Patient Inside the Vehicle.
The pupose of the study is a prospective evaluation of external and internal factors/causes of importance for the trauma and final outcome experienced by persons inside motor vehicles in serious car accidents. We hypothesise that there is an association between the use and function of safety features and the results for the patient and an association between material damage and the severity of injury.
Read the detailed description
We plan to study approximately 200 road accidents with multitraumatised patients and accidents with modern cars and severe material damage with little or moderate damage to persons inside the vehicle. A researcher will be alerted by the call centre (Norwegian 911-equivalent), move to the place of accident and take a pure observers role (unless ethically unacceptable due to lack of other health personnel). He will document the accident including use and condition of safety features, conditions inside the coupe, weather conditions, etc. Other available information on the vehicles, crashtests etc will be gathered from the manufacturer. All medical information will be gathered from the ambulance service, hospitals, pathology and forensic departments. Information from police and fire department will also be gathered.
Patient, next-of-kin, others invloved will be interviewed as appropriate in follow-up.
Four accident groups: Front-to-front or -object > 60 km/hour, same < 60 km/hour, car rolled over on road, car rolled over out-of-road. Factors: Age of vehicle, damage to coupe, cause of accident, on-scene time, initial evaluation by health personnel, injury severity scoring in hospital.
- Conditions
- Multiple Trauma
- Keywords
- multiple trauma, traffic accident, outcome, safety, injury severity
- Medical subject headings
- Multiple Trauma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJan 2005
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple TraumaStudies of the same condition, open and under way.
- 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
- Defined population
- Time perspective
- Other
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- University of Oslo
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Department of Transportation, Ullevaal University Hospital, Health Region East, Norway, Norwegian Air Ambulance Foundation
- Investigators
- Lars Wik, Principal investigator, Ullevaal University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00204204
- Sponsor's protocol ID
- 216-05-04273
- Other IDs
- 200500715-2
- Status last verified
- Aug 2007
- First submitted
- 13 Sep 2005
- Last updated
- 27 Aug 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Multitraumatized Patient. What is the Importance of Forces Involved and the Use of Safety Equipment for the Amount of Trauma to the Patient Inside the Vehicle.
- ClinicalTrials.gov ID
- NCT00204204
- Acronym / sponsor ID
- 216-05-04273
- Conditions
- Multiple Trauma
- Keywords
- multiple trauma, traffic accident, outcome, safety, injury severity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- University of OsloUniversity, hospital or other
- Collaborators
- Royal Department of Transportation, Ullevaal University Hospital, Health Region East, Norway, Norwegian Air Ambulance Foundation
- Study start
- Jan 2005
- Study completion
- Jan 2006 (actual)
- First posted
- 20 Sep 2005 (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 pupose of the study is a prospective evaluation of external and internal factors/causes of importance for the trauma and final outcome experienced by persons inside motor vehicles in serious car accidents. We hypothesise that there is an association between the use and function of safety features and the results for the patient and an association between material damage and the severity of injury.
Detailed description
We plan to study approximately 200 road accidents with multitraumatised patients and accidents with modern cars and severe material damage with little or moderate damage to persons inside the vehicle. A researcher will be alerted by the call centre (Norwegian 911-equivalent), move to the place of accident and take a pure observers role (unless ethically unacceptable due to lack of other health personnel). He will document the accident including use and condition of safety features, conditions inside the coupe, weather conditions, etc. Other available information on the vehicles, crashtests etc will be gathered from the manufacturer. All medical information will be gathered from the ambulance service, hospitals, pathology and forensic departments. Information from police and fire department will also be gathered.
Patient, next-of-kin, others invloved will be interviewed as appropriate in follow-up.
Four accident groups: Front-to-front or -object > 60 km/hour, same < 60 km/hour, car rolled over on road, car rolled over out-of-road. Factors: Age of vehicle, damage to coupe, cause of accident, on-scene time, initial evaluation by health personnel, injury severity scoring in hospital.
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients with multiple trauma from severe motor vehicle accidents in Eastern Norway patients from motor vehicle accidents in Eastern Norway with severe material damage
Key exclusion criteria (0 listed)
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
Not reported in the source record.
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 27 Aug 2007.
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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.
Lars Wik principal investigator
Ullevaal 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 Multiple Trauma, run by University of Oslo at 1 site in Norway.
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 0 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 27 Aug 2007. 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 Norway. 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.
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 27 Aug 2007.