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Multicentre Study: Adherence to the Severe Trauma Patients Pathway in PACA Region (FILTRAUMA-PACA)

I

Intermunicipal Hospital Center Toulon

Status

Completed

Conditions

Trauma

Treatments

Other: Pre-hospital and hospital care

Study type

Observational

Funder types

Other

Identifiers

NCT05401487
2021-CHITS-013

Details and patient eligibility

About

Trauma patient management concerns more than 140,000 patients per year in France. PACA Regional Emergency Observatory (ORU) has issued recommendations to optimize the management of these trauma patients from pre-hospital phase to hospitalization first hours. Ideally, pre-hospital care should not exceed 60 minutes, from accident (first call to the SAMU) to trauma center arrival: the "golden hour" concept. Patients presenting at least one of the Vittel criteria are considered as severely traumatized and are classified according to 3 states of seriousness: unstable, critical and potentially serious. They are referred to trauma centers whose classification is based on their technical facilities, ranging from level 1 (maximum technical facilities) to level 3 (minimum technical facilities). Patients are referred according to their severity, distance from accident site, referral center and availability of each site. Initial hospital management recommends a whole body CT scan within 45 minutes for patients categorized as unstable or critical by pre-hospital doctor and 90 minutes for patients deemed potentially serious.

FILTRAUMA PACA study will analyze the impact of the different management sequences of severe trauma patients based on reliable temporal data because it is automatically incremented in databases and will seek to find a correlation with patient outcome (survival at 24 hours and 28 days).

The main hypothesis tested is that PACA ORU recommended delay respect during trauma patient initial management is correlated with vital prognosis in short (24 hours) and medium terms (28 days).

Full description

Trauma patient management concerns more than 140,000 patients per year in France. Grenoble region was the first one to organize its trauma network around trauma centers ranked by levels (from level 1, the most complete technical platform, to level 3). PACA Regional Health Agency (ARS) set up its dedicated line for severe trauma patients in 2014 based on a regional multi-professional group recommendations, the PACA Regional Emergency Observatory (ORU), in order to optimize the management of these trauma patients from pre-hospital phase to hospitalization first hours (recommendations available online: https://ies-sud.fr/bonnes-pratiques/).

This network suggests a care pathway setting objectives at each stage with operating requirements. Ideally, pre-hospital care should not exceed 60 minutes, from accident (first call to the SAMU) to trauma center arrival: the "golden hour" concept. Patients presenting at least one of the Vittel criteria are considered as severely traumatized and are classified according to 3 states of seriousness: unstable, critical and potentially serious. They are referred to trauma centers whose classification is based on their technical facilities, ranging from level 1 (maximum technical facilities) to level 3 (minimum technical facilities). In PACA region, level 1 technical platforms are North Hospital and Timone Hospital (AP-HM, Marseille, 13) and Sainte Anne Hospital (Toulon, 83). Levels 2 are Sainte Musse Hospital (Toulon, 83), Saint Joseph Hospital (Marseille, 13) and Avignon Hospital (84) and levels 3 correspond to all other hospitals in the region. Patients are referred according to their severity, distance from accident site, referral center and availability of each site. Initial hospital management recommends a whole body CT scan within 45 minutes for patients categorized as unstable or critical by the pre-hospital doctor and 90 minutes for patients deemed potentially serious.

FILTRAUMA PACA study will analyze the impact of the different management sequences of severe trauma patients based on reliable temporal data because it is automatically incremented in databases and will seek to find a correlation with patient outcome (survival at 24 hours and 28 days). The main hypothesis tested is that PACA ORU recommended delay respect during trauma patient initial management is correlated with vital prognosis in short (24 hours) and medium terms (28 days).

Enrollment

265 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age ≥ 18 years
  • Any patient with a severe trauma requiring SMUR activation. Trauma defined by the appearance of a lesion following a fall, a road accident, a burn or the penetration of a foreign body and regulated by one of the PACA region SAMU centres (84, 83, 13, 04)

Exclusion criteria

  • Opposition of the patient, family member or trusted person
  • Patient under legal protection (guardianship or curatorship)

Trial design

265 participants in 1 patient group

Adult patient with a severe trauma requiring SMUR activation
Description:
Trauma defined by appearance of lesions following a fall, a road accident, a burn or the penetration of a foreign body and regulated by one of the SAMU PACA region centres (84, 83, 13, 04)
Treatment:
Other: Pre-hospital and hospital care

Trial contacts and locations

3

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Central trial contact

Sophie LAFOND, PhD

Data sourced from clinicaltrials.gov

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