Multicentre Study: Adherence to the Severe Trauma Patients Pathway in PACA Region

NCT05401487 | Completed

• 1 other identifier: 2021-CHITS-013
• Study Type: observational
• Target: 265
• Locations: 1 country
• Sites: 3

Brief Summary

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).

Conditions

Trauma

Keywords

severe trauma; PACA ORU recommendations; golden hour; emergency rapid response unit; hospital care; prognosis

Outcome Measures

Primary Outcomes (1)

• To evaluate whether compliance with the "golden hour", pre-hospital delay recommended by PACA ORU, influences severe trauma patient vital status.

  Pre-hospital management duration (from the call to the SAMU to arrival at trauma centres) will be derived according to PACA ORU recommendation (time inferior or superior to 1 hour), and will then be related to patient's vital status at 24 hours.

  24 hours

Secondary Outcomes (8)

• To evaluate whether adherence to ORU PACA recommendations in terms of pre-hospital management delays influences severe trauma patient vital status at day 28

  28 days

• To assess whether transport by suitable vehicle to appropriate health facility recommended by the ORU PACA influences the vital status of severe trauma patients.

  28 days

• To assess whether accident categorization and assessment transfer to the SAMU recommended by the ORU PACA influences the vital status of severe trauma patients.

  28 days

• To assess whether management on accident scene recommended by the ORU PACA influences the vital status of severe trauma patients.

  28 days

• To assess whether overall assessment of severity recommended by the ORU PACA influences the vital status of severe trauma patients.

  28 days

Study Arms (1)

Adult patient with a severe trauma requiring SMUR activation

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)

Other: Pre-hospital and hospital care

Interventions

Pre-hospital and hospital care OTHER

Pre-hospital care not exceeding 60 min and a whole body CT scan within 45 min for patients categorized as unstable or critical by the pre-hospital doctor and 90 minutes for patients deemed potentially serious.

Adult patient with a severe trauma requiring SMUR activation

Eligibility Criteria

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

Study Population

Adult patient with a severe trauma requiring SMUR activation

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer: lead

Study Sites (3)

Centre Hospitalier de Digne les Bains

Digne-les-Bains, Alpes-de-Haute-Provence, 04995, France

Location

Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

Toulon, Var, 83056, France

Location

Centre Hospitalier d'Avignon Henri Duffaut

Avignon, Vaucluse, 84000, France

Location

Related Publications (5)

• Bege T, Pauly V, Orleans V, Boyer L, Leone M. Epidemiology of trauma in France: mortality and risk factors based on a national medico-administrative database. Anaesth Crit Care Pain Med. 2019 Oct;38(5):461-468. doi: 10.1016/j.accpm.2019.02.007. Epub 2019 Feb 23.

  PMID: 30807878 BACKGROUND

• Gauss T, Balandraud P, Frandon J, Abba J, Ageron FX, Albaladejo P, Arvieux C, Barbois S, Bijok B, Bobbia X, Charbit J, Cook F, David JS, Maurice GS, Duranteau J, Garrigue D, Gay E, Geeraerts T, Ghelfi J, Hamada S, Harrois A, Kobeiter H, Leone M, Levrat A, Mirek S, Nadji A, Paugam-Burtz C, Payen JF, Perbet S, Pirracchio R, Plenier I, Pottecher J, Rigal S, Riou B, Savary D, Secheresse T, Tazarourte K, Thony F, Tonetti J, Tresallet C, Wey PF, Picard J, Bouzat P; Groupe d'interet en traumatologie grave (GITE). Strategic proposal for a national trauma system in France. Anaesth Crit Care Pain Med. 2019 Apr;38(2):121-130. doi: 10.1016/j.accpm.2018.05.005. Epub 2018 May 29.

  PMID: 29857186 BACKGROUND

• Harmsen AM, Giannakopoulos GF, Moerbeek PR, Jansma EP, Bonjer HJ, Bloemers FW. The influence of prehospital time on trauma patients outcome: a systematic review. Injury. 2015 Apr;46(4):602-9. doi: 10.1016/j.injury.2015.01.008. Epub 2015 Jan 16.

  PMID: 25627482 BACKGROUND

• Ashburn NP, Hendley NW, Angi RM, Starnes AB, Nelson RD, McGinnis HD, Winslow JE, Cline DM, Hiestand BC, Stopyra JP. Prehospital Trauma Scene and Transport Times for Pediatric and Adult Patients. West J Emerg Med. 2020 Feb 21;21(2):455-462. doi: 10.5811/westjem.2019.11.44597.

  PMID: 32191204 BACKGROUND

• Mann NC, Mullins RJ, MacKenzie EJ, Jurkovich GJ, Mock CN. Systematic review of published evidence regarding trauma system effectiveness. J Trauma. 1999 Sep;47(3 Suppl):S25-33. doi: 10.1097/00005373-199909001-00007.

  PMID: 10496607 BACKGROUND

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Marc FOURNIER, MD, PhD

  Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: May 20, 2022
• First Posted: June 2, 2022
• Study Start: November 23, 2022
• Primary Completion: June 20, 2024
• Study Completion: June 20, 2024
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)