Severe TraumaTRAUMA-DOMNCT06580262
Evaluation of the Vittel Criteria for Pre-hospital Triage of Severe Trauma Patients in the French West Indies and in French Guiana
An observational study of Severe Trauma, run by University Hospital Center of Martinique at 2 sites in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Trauma
- What is being tested?
- Routine care
- How many people
- 700 participants
- Where
- 2 sitesFrance
- Study dates
- Oct 2024to Dec 2025
- 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: Patients suspected of severe trauma, treated in the emergency units of the hospitals participating in the study (Martinique, Guadeloupe, Frech Guiana).
Who may be able to join
- 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.
Who cannot join
- Absence of consent from the patient, or representative to the use of the data for the research.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hospital of Cayenne
Cayenne, French Guiana, 97306
Alexis Fremery, MD, alexis.fremery@ch-cayenne.fr
Alexis Fremery, MD
University Hospital Center of Guadeloupe
Pointe à Pitre, Guadeloupe, 97159
Patrick Portecop, PhD, patrick.portecop@chu-guadeloupe.fr
Patrick Portecop, PhD
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Severe Trauma
- Being tested
- Routine care
- Keywords
- Trauma, Severe trauma, Vittel criteria, Hospital emergency, Triage score
- 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.
Routine careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the frequency of each Vittel criterion according to the patient's status within 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).
Measured: 30 days
Secondary outcomes (3)
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
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.
Measured: 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
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).
Measured: 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
Proportion of files for which the "physical circumstances of the accident" sheet was completed by the firefighters.
Measured: 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study startOct 2024 (estimated)
- Primary completionNov 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe TraumaStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Center of Martinique
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Papa Gueye, PhD, Principal investigator, University Hospital Center of Martinique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06580262
- Sponsor's protocol ID
- 22_RIPH3-12
- Acronym
- TRAUMA-DOM
- Status last verified
- Aug 2024
- First submitted
- 22 Aug 2024
- Last updated
- 30 Aug 2024
- 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 30 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Vittel Criteria for Pre-hospital Triage of Severe Trauma Patients in the French West Indies and in French Guiana
- ClinicalTrials.gov ID
- NCT06580262
- Acronym / sponsor ID
- TRAUMA-DOM / 22_RIPH3-12
- Conditions
- Severe Trauma
- Keywords
- Trauma, Severe trauma, Vittel criteria, Hospital emergency, Triage score
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- University Hospital Center of MartiniqueUniversity, hospital or other
- Study start
- Oct 2024 (estimated)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 30 Aug 2024 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients suspected of severe trauma treated in the emergency departments | – | Other: Routine carePatients suspected of severe trauma defined as trauma likely to have caused multiple injuries and/or threatening the vital or functional prognosis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suspected of severe trauma, treated in the emergency units of the hospitals participating in the study (Martinique, Guadeloupe, Frech Guiana).
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Absence of consent from the patient, or representative to the use of the data for the research.
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 |
|---|---|---|
| Routine careThe 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. | Other | Patients suspected of severe trauma treated in the emergency departments |
Primary outcome
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).
3 secondary outcomes
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2024.
Related trials for Severe Trauma
Not yet recruitingPhase 2/3
Valproic AcId for Traumatic BRAin INjury Trial
Moderate Traumatic Brain Injury (TBI), Severe Traumatic Brain Injury
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
RecruitingPhase 2/3
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of RLS-0071 in Newborns With Moderate or Severe Hypoxic-Ischemic Encephalopathy Undergoing Therapeutic Hypothermia
Hypoxic-Ischemic Encephalopathy
Not yet recruiting
Deaf CBT-TS to Reduce Suicide Risk
Depression - Major Depressive Disorder, Anxiety
Recruiting
Comprehensive Assessment of Rehabilitation Experience Using the SAFE Scale
Caregiver Anxiety, Acquired Brain Injury
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.
Papa Gueye, PhD principal investigator
University Hospital Center of Martinique
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Trauma, run by University Hospital Center of Martinique at 2 sites 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 4 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 30 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Papa Gueye, PhD (05 96 55 20 15 ext. +596, papa.gueye@chu-martinique.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the frequency of each Vittel criterion according to the patient's status within 30 days (time frame: 30 days). 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 30 Aug 2024.