Evaluation of the Vittel Criteria for Pre-hospital Triage of Severe Trauma Patients in the French West Indies and in French Guiana

NCT06580262 | Not Yet Recruiting

• 1 other identifier: 22_RIPH3-12
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 2

Brief 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 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.

Conditions

Severe Trauma

Keywords

Trauma; Severe trauma; Vittel criteria; Hospital emergency; Triage score

Outcome Measures

Primary Outcomes (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).

  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

  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

  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

  13 months

Study Arms (1)

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.

Other: Routine care

Interventions

Routine care OTHER

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.

Patients suspected of severe trauma treated in the emergency departments

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients suspected of severe trauma, treated in the emergency units of the hospitals participating in the study (Martinique, Guadeloupe, Frech Guiana).

You may qualify if:

• 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.

You may not qualify if:

• Absence of consent from the patient, or representative to the use of the data for the research.

Sponsors & Collaborators

• University Hospital Center of Martinique: lead

Study Sites (2)

Hospital of Cayenne

Cayenne, French Guiana, 97306, France

Location

University Hospital Center of Guadeloupe

Pointe à Pitre, Guadeloupe, 97159, France

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Papa Gueye, PhD

  University Hospital Center of Martinique

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Papa Gueye, PhD

CONTACT

05 96 55 20 15; papa.gueye@chu-martinique.fr

Florian Negrello, MD

CONTACT

05 96 55 20 15; florian.negrello@chu-martinique.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2024
• First Posted: August 30, 2024
• Study Start: October 1, 2024
• Primary Completion: November 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 30, 2024

Record last verified: 2024-08

Locations

FR (2)