AzTrials
AzTrials

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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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

Other trials in France

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 groups in NCT06580262
Study groupRoleWhat they receive
Patients suspected of severe trauma treated in the emergency departmentsPatients 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.

  1. 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)
  1. 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

  2. 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

  3. 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.

  1. First posted30 Aug 2024
  2. Study startOct 2024 (estimated)
  3. Primary completionNov 2025 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in