High Velocity Transport AccidentsCinescanNCT03679416
Is There a Benefit of Whole Body Computed Tomography (WBCT) for Patients With Only High Velocity Road Traffic Collision (RTC) Vittel Criteria?
An observational study of High Velocity Transport Accidents, run by Rennes University Hospital at 1 site in France.
Trial summary
For victims of high velocity RTC, with no other Vittel criteria of gravity, normal clinical examination of the thorax, abdomen and pelvis and Glasgow Coma Scale (GCS) score of 15 : Study of clinically unsuspected injuries discovered on WBCT Description Predictive factors Diagnostic performances of kinetic elements of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- High Velocity Transport Accidents
- How many people
- 93 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2017to 31 Dec 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: victims of high velocity RTC, with no other Vittel criteria of gravity, normal clinical examination of the thorax, abdomen and pelvis and Glasgow Coma Scale (GCS) score of 15.
Who may be able to join
- Consecutives patients consulting the emergency department between August 1st 2016 and July 31th 2017 :
- Older than 18 y.o.
- WBCT performed,
- Victim of a high velocity RTC as defined by the presence of at least one criteria of the kinetics elements of the Vittel Criteria
- Normal physical exam of the chest, abdomen and pelvis,
- GCS score of 15
Who cannot join
- Opposition of the patient to the use of their CT-scan for research
- Patients who are under legal protection
- Patients who are incarcerated
Trial locations and contacts
1 site in 1 country.
About this study
For victims of high velocity RTC, with no other Vittel criteria of gravity, normal clinical examination of the thorax, abdomen and pelvis and Glasgow Coma Scale (GCS) score of 15 :
- Study of clinically unsuspected injuries discovered on WBCT
- Description
- Predictive factors
- Diagnostic performances of kinetic elements of Vittel criteria, and results of examinations realised at the ED.
- Conditions
- High Velocity Transport Accidents
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of injuries diagnosed by Whole Body Computed Tomography (WBCT) that were not clinically suspected.
Number of injuries diagnosed by WBCT that were not clinically suspected.
Classification in 3 categories according to their management :
- Potentially severe, that involve modification of patients management
- Injuries that could require further investigation according to the symptoms
- Minor injuries that require no further investigation or specific management
Measured: The day of inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2018
- Study start1 Dec 2017
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Velocity Transport AccidentsStudies of the same condition, open and under way.
- More trials run by Rennes 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03679416
- Sponsor's protocol ID
- 35RC17-3082_Cinescan
- Acronym
- Cinescan
- Status last verified
- Sep 2018
- First submitted
- 19 Sep 2018
- Last updated
- 25 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is There a Benefit of Whole Body Computed Tomography (WBCT) for Patients With Only High Velocity Road Traffic Collision (RTC) Vittel Criteria?
- ClinicalTrials.gov ID
- NCT03679416
- Acronym / sponsor ID
- Cinescan / 35RC17-3082_Cinescan
- Conditions
- High Velocity Transport Accidents
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 20 Sep 2018 (actual)
- 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.
For victims of high velocity RTC, with no other Vittel criteria of gravity, normal clinical examination of the thorax, abdomen and pelvis and Glasgow Coma Scale (GCS) score of 15 :
- Study of clinically unsuspected injuries discovered on WBCT
- Description
- Predictive factors
- Diagnostic performances of kinetic elements of Vittel criteria, and results of examinations realised at the ED.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- victims of high velocity RTC, with no other Vittel criteria of gravity, normal clinical examination of the thorax, abdomen and pelvis and Glasgow Coma Scale (GCS) score of 15.
Key inclusion criteria (6 listed)
- Consecutives patients consulting the emergency department between August 1st 2016 and July 31th 2017 :
- Older than 18 y.o.
- WBCT performed,
- Victim of a high velocity RTC as defined by the presence of at least one criteria of the kinetics elements of the Vittel Criteria
- Normal physical exam of the chest, abdomen and pelvis,
Key exclusion criteria (3 listed)
- Opposition of the patient to the use of their CT-scan for research
- Patients who are under legal protection
- Patients who are incarcerated
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
Number of injuries diagnosed by Whole Body Computed Tomography (WBCT) that were not clinically suspected.
Time frame: The day of inclusion
Number of injuries diagnosed by WBCT that were not clinically suspected. Classification in 3 categories according to their management : * Potentially severe, that involve modification of patients management * Injuries that could require further investigation according to the symptoms * Minor injuries that require no further investigation or specific management
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 25 Sep 2018.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 High Velocity Transport Accidents, run by Rennes University Hospital at 1 site in France.
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 6 inclusion and 3 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 25 Sep 2018. 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 France. 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?
Number of injuries diagnosed by Whole Body Computed Tomography (WBCT) that were not clinically suspected. (time frame: The day of inclusion). 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 25 Sep 2018.