- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06580262
Evaluation of the Vittel Criteria for Pre-hospital Triage of Severe Trauma Patients in the French West Indies and in French Guiana (TRAUMA-DOM)
Severe trauma is a public health problem because it is the leading cause of death in young people and the third leading cause of death in France for all ages. These injuries will cause anatomical and functional after-effects that are sometimes permanent, and are therefore among the leading causes of acquired disability in France.
The Vittel criteria constitute a decision-making algorithm of 24 criteria for triage of trauma patients. The presence of only one criterion out of the 24 must direct the patient to a trauma referral center. The existence of only one trauma referral center per territory questions the relevance of using the Vittel criteria in the French Antilles and Guiana.
It therefore seems important that the relevance of the different Vittel criteria be reassessed in our territories, where the typology of patients and the urban network is different compared to that of mainland France. are a common cause of severe trauma, followed by assaults or fights, accidents at work, during leisure or at home, falls from a great height, and weapon-related injuries. Special and rapid care is then necessary.
This is why trauma severity criteria and triage scores are used to target these serious patients and direct them to the appropriate healthcare facilities.
The Vittel criteria constitute a decision-making algorithm of 24 criteria for triage of trauma patients. The presence of only one criterion out of the 24 must direct the patient to a trauma referral center. The existence of only one trauma referral center per territory questions the relevance of using the Vittel criteria in the French Antilles and Guiana.
It therefore seems important that the relevance of the different Vittel criteria be reassessed in Martinique, Guadeloupe and french Guiana, french overseas territories, where the typology of patients and the urban network is different compared to that of mainland France.
Study Overview
Detailed Description
Trauma severity criteria and prehospital triage scores have been proposed since the 1990s. In 2002, a conference of experts in France proposed a decision algorithm for prehospital triage of trauma patients, known as the Vittel criteria. Indeed, the presence of a single criterion out of the 24 others should direct the patient to a trauma referral center (Level 1 Trauma Center). However, since their implementation, few studies have evaluated the relevance of these criteria on over- or under-triage, on the prescription of additional imaging tests, and finally on the prognosis of patients, including disabling sequelae. Indeed, some criteria are subjective and taken alone, it seems difficult to be able to put them on the same level to guide the patient.
In the French Antilles-Guiana inter-region, trauma from accidents on public roads and assaults with knives or firearms are a very common reason for interventions by SMUR teams. Despite this frequency, knowledge of the local epidemiology of these injuries is patchy. Furthermore, the referral of patients treated in pre-hospital care, either by firefighter teams or by the SMUR, is almost always done to the only reference health facility in each of the three French departments (Martinique, Guadeloupe, Guiana). The existence of only one trauma reference center per territory questions the relevance of using the Vittel criteria in the French Antilles-Guyana.
Twenty years after the development of the Vittel criteria, several changes have occurred in society, particularly in road safety and personal protective equipment. These advances would result in a reduction in the risks and severity related to accidents. Despite all these security advances, there is a lack of use and respect for them in the territories of the Antilles-Guiana. At the same time, violence and assaults by weapon have evolved with the use of firearms and weapons of war relatively frequently in our territories.
The relevance of the various Vittel criteria must be reassessed, particularly in the Antilles-Guyana where the typology of patients and the urban network is different from that of mainland France. The hypotheses are that certain criteria such as age, comorbidities, speed and deformation of vehicles, taken in isolation, would not be prognostic criteria for a serious anatomical injury or intensive care or even early mortality. Conversely, other criteria such as the taking of toxics or two-wheeled road accidents would be more important criteria to take into consideration.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Florian Negrello, MD
- Phone Number: +596 05 96 55 20 15
- Email: florian.negrello@chu-martinique.fr
Study Contact Backup
- Name: Papa Gueye, PhD
- Phone Number: +596 05 96 55 20 15
- Email: papa.gueye@chu-martinique.fr
Study Locations
-
-
French Guiana
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Cayenne, French Guiana, France, 97306
- Hospital of Cayenne
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Contact:
- Alexis Fremery, MD
- Email: alexis.fremery@ch-cayenne.fr
-
Principal Investigator:
- Alexis Fremery, MD
-
-
Guadeloupe
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Pointe-à-Pitre, Guadeloupe, France, 97159
- University Hospital Center of Guadeloupe
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Contact:
- Patrick Portecop, PhD
- Email: patrick.portecop@chu-guadeloupe.fr
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Principal Investigator:
- Patrick Portecop, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Minor patients (2-17 years) and adults (≥ 18 years).
- Patients treated in the emergency units of the hospitals participating in the study, whether they were brought by a SAMU/SMUR team, by a rescue and victim assistance vehicle or arrived directly.
- Patients suspected of severe trauma, defined as trauma likely to have caused multiple injuries and/or threatening the vital or functional prognosis.
- Patient if he is able to, or representative of the patient in case of incapacity, having given his agreement for the use of his medical data for this research.
Exclusion Criteria:
- Absence of consent from the patient, or representative to the use of the data for the research.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients suspected of severe trauma treated in the emergency departments
Patients suspected of severe trauma defined as trauma likely to have caused multiple injuries and/or threatening the vital or functional prognosis.
|
The investigator takes care of the patient according to the protocol in force in his department and decides on the final orientation of the patient (transfer to intensive care unit/ICU, hospitalization or home discharge). No recommendations or instructions are given to the investigators. Each investigator is free to decide on his care and the terms of transfer, hospitalization and discharge. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To compare the frequency of each Vittel criterion according to the patient's status within 30 days
Time Frame: 30 days
|
Calculation of the proportion of each Vittel criterion in the two groups defined according to the patient's status at day 30 (alive vs. deceased or hospitalized in intensive care).
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To compare the discriminatory capacity of the different Vittel criteria to estimate the probability of occurrence of a serious anatomical lesion in severely traumatized patients treated by the SAMU/SMUR of the French Antilles-Guiana
Time Frame: 13 months
|
Calculation of the area under the ROC curve of the different Vittel criteria to evaluate a posteriori their performance in predicting, in severely traumatized patients, a serious anatomical lesion defined by an ISS score > 15.
|
13 months
|
|
To compare the discriminatory capacity of the different Vittel criteria to estimate the probability of having to resort to a massive transfusion in severely traumatized patients treated by the SAMU/SMUR of the French Antilles-Guiana
Time Frame: 13 months
|
Calculation of the area under the ROC curve of the different Vittel criteria to evaluate a posteriori their performance in predicting a massive transfusion (defined by 5 red blood cell concentrates (RBCs) in 3 hours or 8 RBCs in 6 hours or 10 RBCs in 24 hours).
|
13 months
|
|
To assess the feasibility of having firefighters fill out a form to collect among the Vittel criteria those relating to the physical circumstances of the accident
Time Frame: 13 months
|
Proportion of files for which the "physical circumstances of the accident" sheet was completed by the firefighters.
|
13 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Papa Gueye, PhD, University Hospital Center of Martinique
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22_RIPH3-12
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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