TraumaPRE-SCEAUNCT05588791
Relevance of Whole-body Computed Tomography Prescription in the Emergency Department : an Identification Tool for Low Risk Patients
An observational study of Trauma, run by University Hospital, Rouen at 1 site in France.
Trial summary
The whole-body scanner (SCE) is a powerful examination that guides the management of patients severely traumatized. However, the systematic use of this examination in emergency departments is responsible for a large proportion of normal examinations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trauma
- What is being tested?
- whole-body computed tomography
- How many people
- 2,018 participants
- Where
- 1 siteFrance
- Study dates
- 23 Jun 2023to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Adult, Older adult
Study population: All adult patients consulting in the emergency room after a trauma whose mechanism of injury is a fall or a road accident and indicated for the realization of a whole body scanner.
Who may be able to join
- Any adult patient undergoing an SCE as part of a post-traumatic lesion assessment during a stay in the emergency room.
- Mechanism of injury: road accident or fall.
- Patient having read and understood the information letter and given his oral consent.
Who cannot join
- Neurological impairment defined by a Glasgow score of less than 8.
- Respiratory failure with SpO2 < 90% on oxygen or with the use of ventilatory assistance.
- Hemodynamic failure with vascular filling greater than 1000 cc or recourse to catecholamines.
- Acute alcoholism.
- Taking narcotics.
- History of cognitive disorders.
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- Current pregnancy.
- Suicidal patient.
- Trauma related to a brawl
- Penetrating trauma.
- Hemophilia.
- Known thrombocytopenia at the time of inclusion.
- Heart, lung, liver or kidney transplant patient.
- Person deprived of liberty by an administrative or judicial decision or person placed under legal safeguard / sub-tutorship or curatorship.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Services des Urgences Adultes
Rouen, 76031
Mehdi MI TAALBA, Dr, (0)2 32 88 66 87 ext. +33, mehdi.taalba@chu-rouen.fr
About this study
Official title: Pertinence de la PREscription du Scanner Corps-Entier Aux Urgences : un Outil d'Identification Des Patients à Bas Risque
The whole-body scanner (SCE) is a powerful examination that guides the management of patients severely traumatized. However, the systematic use of this examination in emergency departments is responsible for a large proportion of normal examinations. In addition to the non-negligible direct cost, the average irradiation of 20 mSv would give an adult a 1 in 1000 risk of developing a cancer. The Vittel score makes it possible to categorize pre-hospital patients as seriously traumatized to guide the sending of resources and direct them to a center equipped with a suitable technical platform.
The use of this score to condition the prescription of the ECS is at the origin of an over-triage important since one out of two patients who validates at least one criterion has no lesion on imaging. The purpose of this research project is to validate a decision support tool to objectively guide the emergency physician in its use of the ECS. At the same time, the economic impact of such a procedure will be analysed.
- Conditions
- Trauma
- Being tested
- whole-body computed tomography
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
whole-body computed tomographyDiagnostic test
whole-body computed tomography prescription in the emergency department : an identification tool for low risk patients
What is being measured
The primary outcome is the main question the study is designed to answer.
PHASE I: Assess the negative predictive value of a 15-criteria score to exclude the traumatized patient from a whole-body CT (SCE) imaging strategy to emergencies.
The main judgment criterion is defined by the uselessness of the whole body scanner, evaluated from the SCE voucher which will contain the 15 criteria from phase I.
Measured: through study Phase 1 completion, an average of 1 year
PHASE II: To quantify the effective reduction in SCE requests after the validated score is made available on the SCE prescription vouchers.
The main judgment criterion is the prescription of an irrelevant whole-body scanner (a patient whose 15 safety criteria are validated).
Measured: through study Phase 2 completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2022
- Study start23 Jun 2023
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TraumaStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 2,018 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05588791
- Sponsor's protocol ID
- 2020/0425/HP
- Acronym
- PRE-SCEAU
- Status last verified
- Oct 2024
- First submitted
- 14 Oct 2022
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pertinence de la PREscription du Scanner Corps-Entier Aux Urgences : un Outil d'Identification Des Patients à Bas Risque
- ClinicalTrials.gov ID
- NCT05588791
- Acronym / sponsor ID
- PRE-SCEAU / 2020/0425/HP
- Conditions
- Trauma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,018 participants (estimated)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 23 Jun 2023 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 20 Oct 2022 (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.
The whole-body scanner (SCE) is a powerful examination that guides the management of patients severely traumatized. However, the systematic use of this examination in emergency departments is responsible for a large proportion of normal examinations. In addition to the non-negligible direct cost, the average irradiation of 20 mSv would give an adult a 1 in 1000 risk of developing a cancer. The Vittel score makes it possible to categorize pre-hospital patients as seriously traumatized to guide the sending of resources and direct them to a center equipped with a suitable technical platform.
The use of this score to condition the prescription of the ECS is at the origin of an over-triage important since one out of two patients who validates at least one criterion has no lesion on imaging. The purpose of this research project is to validate a decision support tool to objectively guide the emergency physician in its use of the ECS. At the same time, the economic impact of such a procedure will be analysed.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All adult patients consulting in the emergency room after a trauma whose mechanism of injury is a fall or a road accident and indicated for the realization of a whole body scanner.
Key inclusion criteria (3 listed)
- Any adult patient undergoing an SCE as part of a post-traumatic lesion assessment during a stay in the emergency room.
- Mechanism of injury: road accident or fall.
- Patient having read and understood the information letter and given his oral consent.
Key exclusion criteria (14 listed)
- Neurological impairment defined by a Glasgow score of less than 8.
- Respiratory failure with SpO2 < 90% on oxygen or with the use of ventilatory assistance.
- Hemodynamic failure with vascular filling greater than 1000 cc or recourse to catecholamines.
- Acute alcoholism.
- Taking narcotics.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| whole-body computed tomographywhole-body computed tomography prescription in the emergency department : an identification tool for low risk patients | Diagnostic test | – |
Primary outcome
PHASE I: Assess the negative predictive value of a 15-criteria score to exclude the traumatized patient from a whole-body CT (SCE) imaging strategy to emergencies.
Time frame: through study Phase 1 completion, an average of 1 year
The main judgment criterion is defined by the uselessness of the whole body scanner, evaluated from the SCE voucher which will contain the 15 criteria from phase I.
PHASE II: To quantify the effective reduction in SCE requests after the validated score is made available on the SCE prescription vouchers.
Time frame: through study Phase 2 completion, an average of 1 year
The main judgment criterion is the prescription of an irrelevant whole-body scanner (a patient whose 15 safety criteria are validated).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Individual participant dataSharing planned: No
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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.
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 Trauma, run by University Hospital, Rouen 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 3 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 8 Oct 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David MALLET (0033 2 32 88 82 65, secretariat.DRC@chu-rouen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PHASE I: Assess the negative predictive value of a 15-criteria score to exclude the traumatized patient from a whole-body CT (SCE) imaging strategy to emergencies. (time frame: through study Phase 1 completion, an average of 1 year). The study lists 2 primary outcomes in all. 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 8 Oct 2024.