TraumaFILTRAUMA-PACANCT05401487
Multicentre Study: Adherence to the Severe Trauma Patients Pathway in PACA Region
An observational study of Trauma, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trauma
- What is being tested?
- Pre-hospital and hospital care
- How many people
- 265 participants
- Where
- 3 sitesFrance
- Study dates
- 23 Nov 2022to 20 Jun 2024
- 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: Adult patient with a severe trauma requiring SMUR activation
Who may be able to join
- 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)
Who cannot join
- Opposition of the patient, family member or trusted person
- Patient under legal protection (guardianship or curatorship)
Trial locations and contacts
3 sites in 1 country.
France3 sites
Centre Hospitalier d'Avignon Henri Duffaut
Avignon, Vaucluse, 84000
Centre Hospitalier de Digne les Bains
Digne-les-Bains, Alpes-de-Haute-Provence, 04995
Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
Toulon, Var, 83056
About this study
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).
Read the detailed 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).
- Conditions
- Trauma
- Being tested
- Pre-hospital and hospital care
- Keywords
- severe trauma, PACA ORU recommendations, golden hour, emergency rapid response unit, hospital care, prognosis
- 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.
Pre-hospital and hospital careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: Pre-hospital and hospital care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Pre-hospital management duration (from the call to the SAMU to arrival at trauma centres) will be derived according to PACA ORU recommendation (inferior or superior 1 hour), and will then be related to patient's vital status at day 28.
Measured: 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.
The influence of adherence to ORU PACA recommendations on severe trauma patient vital status (at 24 hours and 28 days after trauma) will be evaluated according to transport by suitable vehicle to appropriate health facility
Measured: 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.
The influence of adherence to ORU PACA recommendations on severe trauma patient vital status (at 24 hours and 28 days after trauma) will be evaluated according to accident categorization and assessment transfer to the SAMU
Measured: 28 days
To assess whether management on accident scene recommended by the ORU PACA influences the vital status of severe trauma patients.
The influence of adherence to ORU PACA recommendations on severe trauma patient vital status (at 24 hours and 28 days after trauma) will be evaluated according to management on accident scene
Measured: 28 days
To assess whether overall assessment of severity recommended by the ORU PACA influences the vital status of severe trauma patients.
The influence of adherence to ORU PACA recommendations on severe trauma patient vital status (at 24 hours and 28 days after trauma) will be evaluated according to Overall assessment of severity.
Measured: 28 days
To assess whether time required to perform a whole body CT scan recommended by the ORU PACA influences the vital status of severe trauma patients.
The influence of adherence to ORU PACA recommendations on severe trauma patient vital status (at 24 hours and 28 days after trauma) will be evaluated according to time required to perform a whole body CT scan.
Measured: 28 days
To analyze risk factors for non-adherence to recommendations
The risk factors for non-adherence to recommendations will be identified through primary and first secondary outcome criteria analysis. They will then be described (structural, patient-related).
Measured: 28 days
To analyze errors in referring severe trauma patients to an appropriate care facility
Identification and analysis of the reasons for mis-referrals of severe trauma patients to an approved care facility.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study start23 Nov 2022
- Primary completion20 Jun 2024
- Study completion20 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for 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
- 265 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc FOURNIER, MD, PhD, Study director, Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05401487
- Sponsor's protocol ID
- 2021-CHITS-013
- Acronym
- FILTRAUMA-PACA
- Status last verified
- Jul 2026
- First submitted
- 20 May 2022
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30807878Gauss 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.
PubMed 29857186Harmsen 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.
PubMed 25627482Ashburn 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.
PubMed 32191204Mann 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.
PubMed 10496607
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre Study: Adherence to the Severe Trauma Patients Pathway in PACA Region
- ClinicalTrials.gov ID
- NCT05401487
- Acronym / sponsor ID
- FILTRAUMA-PACA / 2021-CHITS-013
- Conditions
- Trauma
- Keywords
- severe trauma, PACA ORU recommendations, golden hour, emergency rapid response unit, hospital care, prognosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 265 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur MerUniversity, hospital or other
- Study start
- 23 Nov 2022 (actual)
- Primary completion
- 20 Jun 2024 (actual)
- Study completion
- 20 Jun 2024 (actual)
- First posted
- 2 Jun 2022 (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.
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).
Detailed 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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patient with a severe trauma requiring SMUR activation | – | Other: Pre-hospital and hospital careTrauma 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patient with a severe trauma requiring SMUR activation
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (2 listed)
- Opposition of the patient, family member or trusted person
- Patient under legal protection (guardianship or curatorship)
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 |
|---|---|---|
| Pre-hospital and hospital carePre-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. | Other | Adult patient with a severe trauma requiring SMUR activation |
Primary outcome
To evaluate whether compliance with the "golden hour", pre-hospital delay recommended by PACA ORU, influences severe trauma patient vital status.
Time frame: 24 hours
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.
8 secondary outcomes
To evaluate whether adherence to ORU PACA recommendations in terms of pre-hospital management delays influences severe trauma patient vital status at day 28
Time frame: 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.
Time frame: 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.
Time frame: 28 days
To assess whether management on accident scene recommended by the ORU PACA influences the vital status of severe trauma patients.
Time frame: 28 days
To assess whether overall assessment of severity recommended by the ORU PACA influences the vital status of severe trauma patients.
Time frame: 28 days
To assess whether time required to perform a whole body CT scan recommended by the ORU PACA influences the vital status of severe trauma patients.
Time frame: 28 days
To analyze risk factors for non-adherence to recommendations
Time frame: 28 days
To analyze errors in referring severe trauma patients to an appropriate care facility
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Background: PubMed 30807878Bege 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.
- Background: PubMed 29857186Gauss 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.
- Background: PubMed 25627482Harmsen 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.
- Background: PubMed 32191204Ashburn 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.
- Background: PubMed 10496607Mann 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.
- Individual participant dataSharing planned: No
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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.
Marc FOURNIER, MD, PhD study director
Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trauma, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 3 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate whether compliance with the "golden hour", pre-hospital delay recommended by PACA ORU, influences severe trauma patient vital status. (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05401487, which also lists 5 linked publications.
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 7 Jul 2026; AzTrials last refreshed its copy on 31 Oct 2026.