NCT05588791 Relevance of Whole-body Computed Tomography Prescription in the Emergency Department : an Identification Tool for Low Risk Patients
| NCT ID | NCT05588791 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Rouen |
| Condition | Trauma |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,018 participants |
| Start Date | 2023-06-23 |
| Primary Completion | 2026-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,018 participants in total. It began in 2023-06-23 with a primary completion date of 2026-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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. * 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05588791 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Trauma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05588791 currently recruiting?
Yes, NCT05588791 is actively recruiting participants. Contact the research team at secretariat.DRC@chu-rouen.fr for enrollment information.
Where is the NCT05588791 trial being conducted?
This trial is being conducted at Rouen, France.
Who is sponsoring the NCT05588791 clinical trial?
NCT05588791 is sponsored by University Hospital, Rouen. The trial plans to enroll 2,018 participants.