Aortic RuptureNCT01632774
Analysis of Risk Factors for Death After Blunt Traumatic Rupture of the Thoracic Aorta
An observational study of Aortic Rupture, run by University of Zurich at 1 site in Switzerland.
Trial summary
Aortic injuries after blunt thoracic trauma are compared to the great incidence of accidents relatively rare, but potentially serious leading to death at scene in most of the cases. The study was undertaken to delineate mortality and its risk factors on three different levels (pre-hospital, in-hospital and overall). Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Aortic Rupture
- How many people
- 85 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 1990to Dec 2003
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Hospitalized patients Patients who died at the scene
Who may be able to join
- During the study period of 14 years (January 1990 to December 2003), all consecutive cases with traumatic rupture of the thoracic aorta being reported in the greater area of Zurich with about one million inhabitants were included in the present study
Who cannot join
- Non-traumatic aortic rupture
- Non-traumatic aortic dissection
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Division of Internal Medicine
Zurich, Canton of Zurich, 8091
About this study
Aortic injuries after blunt thoracic trauma are compared to the great incidence of accidents relatively rare, but potentially serious leading to death at scene in most of the cases. The study was undertaken to delineate mortality and its risk factors on three different levels (pre-hospital, in-hospital and overall). Between 1990 and 2003, all consecutive patients and victims with traumatic aortic rupture were retrospectively analyzed by reviewing hospital and autopsy records.
Read the detailed description
During the study period of 14 years (January 1990 to December 2003), all consecutive cases with traumatic rupture of the thoracic aorta being reported in the greater area of Zurich with about one million inhabitants were included in the present study. Related to the final outcome, patient data were drawn either from medical reports from the University Hospital of Zurich, which is a tertiary care teaching hospital and level I trauma center for the eastern part of Switzerland, or from autopsy reports from the Institute of Forensic Medicine of the University of Zurich, respectively. The latter group includes all patients, who died on the scene, in a assigning primary care hospital or on the way to the University Hospital of Zurich. In Switzerland, the criteria used for performing a full autopsy after a blunt traumatic death include all cases in which the events leading to the death are unclear or in which the cause of death is the result of suicide or extrinsic harm. Both, deaths at the scene and in-hospital deaths were included in the study.
- Conditions
- Aortic Rupture
- Medical subject headings
- Aortic Rupture
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2012 (estimated)
- Study startJan 1990
- Primary completionDec 2003
- Study completionDec 2003
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 Aortic RuptureStudies of the same condition, open and under way.
- More trials run by University of ZurichThe 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 only
- Time perspective
- Retrospective
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Franzen, MD, Principal investigator, University Hospital Zurich, Division of Internal Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01632774
- Sponsor's protocol ID
- TAR
- Status last verified
- Jun 2012
- First submitted
- 28 Jun 2012
- Last updated
- 3 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Franzen D, Genoni M. Analysis of risk factors for death after blunt traumatic rupture of the thoracic aorta. Emerg Med J. 2015 Feb;32(2):124-9. doi: 10.1136/emermed-2013-202639. Epub 2013 Sep 4.
PubMed 24005640
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Risk Factors for Death After Blunt Traumatic Rupture of the Thoracic Aorta
- ClinicalTrials.gov ID
- NCT01632774
- Acronym / sponsor ID
- TAR
- Conditions
- Aortic Rupture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Jan 1990
- Primary completion
- Dec 2003 (actual)
- Study completion
- Dec 2003 (actual)
- First posted
- 3 Jul 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.
Aortic injuries after blunt thoracic trauma are compared to the great incidence of accidents relatively rare, but potentially serious leading to death at scene in most of the cases. The study was undertaken to delineate mortality and its risk factors on three different levels (pre-hospital, in-hospital and overall). Between 1990 and 2003, all consecutive patients and victims with traumatic aortic rupture were retrospectively analyzed by reviewing hospital and autopsy records.
Detailed description
During the study period of 14 years (January 1990 to December 2003), all consecutive cases with traumatic rupture of the thoracic aorta being reported in the greater area of Zurich with about one million inhabitants were included in the present study. Related to the final outcome, patient data were drawn either from medical reports from the University Hospital of Zurich, which is a tertiary care teaching hospital and level I trauma center for the eastern part of Switzerland, or from autopsy reports from the Institute of Forensic Medicine of the University of Zurich, respectively. The latter group includes all patients, who died on the scene, in a assigning primary care hospital or on the way to the University Hospital of Zurich. In Switzerland, the criteria used for performing a full autopsy after a blunt traumatic death include all cases in which the events leading to the death are unclear or in which the cause of death is the result of suicide or extrinsic harm. Both, deaths at the scene and in-hospital deaths were included in the study.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Hospitalized patients Patients who died at the scene
Key inclusion criteria (1 listed)
- During the study period of 14 years (January 1990 to December 2003), all consecutive cases with traumatic rupture of the thoracic aorta being reported in the greater area of Zurich with about one million inhabitants were included in the present study
Key exclusion criteria (2 listed)
- Non-traumatic aortic rupture
- Non-traumatic aortic dissection
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 3 Jul 2012.
- Derived from this study: PubMed 24005640Franzen D, Genoni M. Analysis of risk factors for death after blunt traumatic rupture of the thoracic aorta. Emerg Med J. 2015 Feb;32(2):124-9. doi: 10.1136/emermed-2013-202639. Epub 2013 Sep 4.
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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.
Daniel Franzen, MD principal investigator
University Hospital Zurich, Division of Internal Medicine
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 Aortic Rupture, run by University of Zurich at 1 site in Switzerland.
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 2 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 3 Jul 2012. 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 Switzerland. 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?
On the ClinicalTrials.gov record for NCT01632774, 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 3 Jul 2012.