Wounds and InjuriesTRAUMINXCLUSIFNCT04275791
Assessment of the Benefit of an Inclusive Health Organization on the Prognosis of Severe Trauma Patients
A study testing Triage in people with Wounds and Injuries, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Appropriate management reduces the mortality of severe trauma victims. This is based on a pre-hospital medical assessment of severity, the initiation of life-saving treatments at the pre-hospital level, and referral to a hospital with human and material resources adapted to the patient's severity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wounds and Injuries
- What is being tested?
- Triage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,193 participants
- Where
- 1 siteFrance
- Study dates
- 23 May 2022to 28 Jan 2024
- Phase
- Interventional
- 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
Who may be able to join
- Patients cared for in the aftermath of a severe trauma, by a pre-hospital medical team regulated by the territorially competent SAMU, who arrived at the hospital alive.
Who cannot join
- Age < 18 years
- Patients with no signs of life on hospital arrival and reported deceased within 30 minutes of admission
- Patients with severe burns (>10% skin area burned)
Trial locations and contacts
1 site in 1 country.
About this study
Appropriate management reduces the mortality of severe trauma victims. This is based on a pre-hospital medical assessment of severity, the initiation of life-saving treatments at the pre-hospital level, and referral to a hospital with human and material resources adapted to the patient's severity. The objective of this research project is to show that the 28-day mortality after severe trauma is lower in a structured health system, compared to a non-structured system.
Read the detailed description
Appropriate management reduces the mortality of severe trauma victims defined by an Injury Severity Score (ISS) greater than 15 or the need for specialized and/or urgent treatment. This is based on a pre-hospital medical assessment of severity, the initiation of life-saving treatments at the pre-hospital level, and referral to a hospital with human and material resources adapted to the patient's severity.
The trauma hospital organisation in France is of the "exclusive" type. It contrasts trauma centres with other hospitals, only providing care for severe trauma victims in the former, which are most often confused with university hospitals. The choice of referral to this type of centre is made using a triage algorithm known as "de Vittel". In addition to an insufficient network within a region leading to longer hospital access time, this organisation leads to saturation of the referral centres by patients with few lesions. For this reason, this organisation has been rethought in an innovative way within the Auvergne-Rhône-Alpes region, in favour of an "inclusive" system that takes the form of a network of hospitals with capacities to receive severely traumatised patients that vary according to their equipment and personnel. Patients are referred within this network according to their severity category (unstable, stabilized or stable).
The main objective is to show that the 28-day mortality of severely traumatized persons oriented according to their severity in an inclusive system is lower, at identical severity, than in a conventional exclusive system in which the orientation is guided by the Vittel algorithm.
Secondary objectives are to show that the management of severe traumatized persons oriented according to their severity in an inclusive system, compared to the management in an exclusive conventional system in which the orientation is guided by the Vittel/ASCOTT algorithm, is associated, at identical severity, with :
- Less under-triage;
- Less over-triage;
- A lower incidence of secondary transfers to a trauma center;
- A greater number of days living without mechanical ventilation (during the first 28 days);
- More days living without resuscitation (within the first 28 days);
- More frequent and rapid use of whole-body CT scans with contrast injection;
- More frequent and rapid use of specialized emergency therapies (laparotomy or hemostasis thoracotomy, embolization, craniectomy, intracranial pressure measurement, chest drainage).
- Conditions
- Wounds and Injuries
- Being tested
- Triage
- Keywords
- Advanced Trauma Life Support Care, Trauma Severity Indices, Trauma Centers, Triage
- 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.
TriageOther
Experimental : Trauma patient orientation in a structured regional health organization, composed of trauma centers hierarchized in several levels according to their capacity to receive severe traumatized persons.
| Study group | Role | What they receive |
|---|---|---|
| hierarchized | Experimental | Structured regional health organization, composed of trauma centers hierarchized in several levels according to their capacity to receive severe traumatized persons. Receives: Other: Triage |
| all-or-nothing | No intervention | Structured regional health organization, composed of non-hierarchical trauma centers at different levels according to their capacity to receive severe trauma victims (all-or-nothing type). |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day mortality
The primary endpoint will be 28-day mortality, defined as the occurrence of death from any cause within the first 28 days following trauma.
Measured: 28th day
Secondary outcomes (22)
Undertriage
Undertriage, defined as the management outside the trauma care system adapted to their condition of patients whose ISS is strictly greater than 15, or presenting at least one of the following criteria:
- the need for transfusion of more than 4 red blood cell concentrates during the first 6 hours of management;
- the presence of severe head trauma with CT scan lesions;
- the presence of a spinal cord injury;
- the need for specialized emergency surgery (laparotomy or hemostasis thoracotomy, embolization, craniectomy, intracranial pressure measurement, chest drainage) within the first 24 hours;
- the need for a secondary inter-hospital transfer to a trauma center. This variable will be assessed at the end of the 28th day, based on the data contained in the medical file and the administrative file.
Measured: 28th day
Over-triage
Over-triage, defined by the management of severely traumatized patients in the trauma centre and whose ISS is less than or equal to 15 and who do not present any of the following criteria :
- the need for transfusion of more than 4 red blood cell concentrates during the first 6 hours of management;
- the presence of severe head trauma with CT scan lesions;
- the presence of a spinal cord injury;
- the need for specialized emergency surgery (laparotomy or hemostasis thoracotomy, embolization, craniectomy, intracranial pressure measurement, chest drainage) within the first 24 hours;
- the need for transfer to a trauma center. This variable will be evaluated at the end of the 28th day, based on the data contained in the medical file and in the administrative file
Measured: 28th day
Transfer to a trauma centre
Tranfer to a trauma centre at the end of the pre-hospital phase. This criterion will be evaluated at the time of admission of the patient out of the SMUR ambulance. Trauma centres are considered to be hospitals with a unit dedicated to the care of these patients, identified as such by the territorially competent regional health agency;
Measured: 1 day
Secondary inter-hospital transfer
The need for secondary inter-hospital transfer to a specialized trauma centre or a higher-level trauma centre. This variable is defined as the transfer of the patient, during the study period, from a hospital that does not have a trauma centre to the trauma centre of a hospital that does, or the transfer of the patient from a hospital trauma centre to a higher level trauma centre (III to II, II to I, III to I). This variable will be evaluated at the end of day 28, based on the data contained in the medical file and the administrative file. Transfers for specialized but non-urgent care (e.g. hand microsurgery that can be carried out beyond the first 24 hours) will not be counted as secondary inter-hospital transfers;
Measured: 28th day
Days living without mechanical ventilation
The number of days living without mechanical ventilation during the first 28 days. This criterion will be assessed at the end of the 28th day, by subtracting from 28 the number of days the patient received ventilatory support by mechanical ventilation. The change of day is made at midnight. By definition, deceased patients are assigned 0 days without mechanical ventilation;
Measured: 28th day
Days living without resuscitation
The number of days living without resuscitation during the first 28 days. This criterion will be assessed at the end of the 28th day, by subtracting from 28 the number of days the patient will have been in resuscitation. The change of day is made at midnight. By definition, deceased patients are assigned 0 days out of resuscitation;
Measured: 28th day
Length of stay in resuscitation
This variable will be evaluated at the end of the 28th day, based on the data contained in the medical record and in the administrative file;
Measured: 28th day
Modalities of the post-traumatic injury assessment by chest X-ray
This criterion will be assessed at the end of the first 24 hours of hospitalization. It will be assessed by first performing a chest X-ray
Measured: first 24 hours of hospitalization
Modalities of the post-traumatic injury assessment by pelvis X-ray
This criterion will be assessed at the end of the first 24 hours of hospitalization. It will be assessed by first performing a pelvis X-ray
Measured: first 24 hours of hospitalization
Modalities of the post-traumatic injury assessment by abdominal ultrasound
This criterion will be assessed at the end of the first 24 hours of hospitalization. It will be assessed by first performing an abdominal ultrasound
Measured: first 24 hours of hospitalization
Modalities of the post-traumatic injury assessment by transcranial Doppler scan
This criterion will be assessed at the end of the first 24 hours of hospitalization. It will be assessed by first performing a transcranial Doppler scan
Measured: first 24 hours of hospitalization
Modalities of the post-traumatic injury assessment by CT scan
This criterion will be assessed at the end of the first 24 hours of hospitalization. This evaluation will include a whole body CT scan with contrast media injection
Measured: first 24 hours of hospitalization
Modalities of the post-traumatic injury assessment by bone radiographs
This criterion will be assessed at the end of the first 24 hours of hospitalization. This evaluation will include guided bone radiographs;
Measured: first 24 hours of hospitalization
Need for and timing of laparotomy
The need for and timing of laparotomy within the first 24 hours. This variable will be evaluated at the end of the 28th day, based on the data contained in the medical file and in the administrative file;
Measured: 28th day
Need for and timing of hemostasis thoracotomy
The need for and timing of hemostasis thoracotomy within the first 24 hours. This variable will be evaluated at the end of the 28th day, based on the data contained in the medical file and in the administrative file;
Measured: 28th day
Need for and timing of embolization
The need for and timing of embolization within the first 24 hours. This variable will be evaluated at the end of the 28th day, based on the data contained in the medical file and in the administrative file;
Measured: 28th day
Need for and timing of craniectomy
The need for and timing of craniectomy within the first 24 hours. This variable will be evaluated at the end of the 28th day, based on the data contained in the medical file and in the administrative file;
Measured: 28th day
Need for and timing of intracranial pressure measurement
The need for and timing of intracranial pressure measurement within the first 24 hours. This variable will be evaluated at the end of the 28th day, based on the data contained in the medical file and in the administrative file;
Measured: 28th day
Need for and timing of chest drainage
The need for and timing of chest drainage within the first 24 hours. This variable will be evaluated at the end of the 28th day, based on the data contained in the medical file and in the administrative file;
Measured: 28th day
Distance to the nearest available pre-hospital medical facility
The distance to the nearest available pre-hospital medical facility. This variable is defined as the distance between the accident and the nearest available pre-hospital medical facility (light vehicles, mobile hospital units, helicopters) available at the time of the alert in the department concerned.
Measured: 1 day
Length of mechanical ventilation
This variable will be evaluated at the end of the 28th day, based on the data contained in the medical record and in the administrative file;
Measured: 28th day
Length of hospital stay
This variable will be evaluated at the end of the 28th day, based on the data contained in the medical record and in the administrative file;
Measured: 28th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2020
- Study start23 May 2022
- Primary completion31 Dec 2023
- Study completion28 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wounds and InjuriesStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 2,193 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- RAUX Mathieu, MD PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04275791
- Sponsor's protocol ID
- APHP180625
- Acronym
- TRAUMINXCLUSIF
- Status last verified
- Mar 2026
- First submitted
- 31 Jan 2020
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Benefit of an Inclusive Health Organization on the Prognosis of Severe Trauma Patients
- ClinicalTrials.gov ID
- NCT04275791
- Acronym / sponsor ID
- TRAUMINXCLUSIF / APHP180625
- Conditions
- Wounds and Injuries
- Keywords
- Advanced Trauma Life Support Care, Trauma Severity Indices, Trauma Centers, Triage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,193 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 23 May 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 28 Jan 2024 (actual)
- First posted
- 19 Feb 2020 (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.
Appropriate management reduces the mortality of severe trauma victims. This is based on a pre-hospital medical assessment of severity, the initiation of life-saving treatments at the pre-hospital level, and referral to a hospital with human and material resources adapted to the patient's severity. The objective of this research project is to show that the 28-day mortality after severe trauma is lower in a structured health system, compared to a non-structured system.
Detailed description
Appropriate management reduces the mortality of severe trauma victims defined by an Injury Severity Score (ISS) greater than 15 or the need for specialized and/or urgent treatment. This is based on a pre-hospital medical assessment of severity, the initiation of life-saving treatments at the pre-hospital level, and referral to a hospital with human and material resources adapted to the patient's severity.
The trauma hospital organisation in France is of the "exclusive" type. It contrasts trauma centres with other hospitals, only providing care for severe trauma victims in the former, which are most often confused with university hospitals. The choice of referral to this type of centre is made using a triage algorithm known as "de Vittel". In addition to an insufficient network within a region leading to longer hospital access time, this organisation leads to saturation of the referral centres by patients with few lesions. For this reason, this organisation has been rethought in an innovative way within the Auvergne-Rhône-Alpes region, in favour of an "inclusive" system that takes the form of a network of hospitals with capacities to receive severely traumatised patients that vary according to their equipment and personnel. Patients are referred within this network according to their severity category (unstable, stabilized or stable).
The main objective is to show that the 28-day mortality of severely traumatized persons oriented according to their severity in an inclusive system is lower, at identical severity, than in a conventional exclusive system in which the orientation is guided by the Vittel algorithm.
Secondary objectives are to show that the management of severe traumatized persons oriented according to their severity in an inclusive system, compared to the management in an exclusive conventional system in which the orientation is guided by the Vittel/ASCOTT algorithm, is associated, at identical severity, with :
- Less under-triage;
- Less over-triage;
- A lower incidence of secondary transfers to a trauma center;
- A greater number of days living without mechanical ventilation (during the first 28 days);
- More days living without resuscitation (within the first 28 days);
- More frequent and rapid use of whole-body CT scans with contrast injection;
- More frequent and rapid use of specialized emergency therapies (laparotomy or hemostasis thoracotomy, embolization, craniectomy, intracranial pressure measurement, chest drainage).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hierarchized | Experimental | Other: TriageStructured regional health organization, composed of trauma centers hierarchized in several levels according to their capacity to receive severe traumatized persons. |
| all-or-nothing | No intervention | –Structured regional health organization, composed of non-hierarchical trauma centers at different levels according to their capacity to receive severe trauma victims (all-or-nothing type). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients cared for in the aftermath of a severe trauma, by a pre-hospital medical team regulated by the territorially competent SAMU, who arrived at the hospital alive.
Key exclusion criteria (3 listed)
- Age < 18 years
- Patients with no signs of life on hospital arrival and reported deceased within 30 minutes of admission
- Patients with severe burns (>10% skin area burned)
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 |
|---|---|---|
| TriageExperimental : Trauma patient orientation in a structured regional health organization, composed of trauma centers hierarchized in several levels according to their capacity to receive severe traumatized persons. | Other | hierarchized |
Primary outcome
28-day mortality
Time frame: 28th day
The primary endpoint will be 28-day mortality, defined as the occurrence of death from any cause within the first 28 days following trauma.
22 secondary outcomes
Undertriage
Time frame: 28th day
Over-triage
Time frame: 28th day
Transfer to a trauma centre
Time frame: 1 day
Secondary inter-hospital transfer
Time frame: 28th day
Days living without mechanical ventilation
Time frame: 28th day
Days living without resuscitation
Time frame: 28th day
Length of stay in resuscitation
Time frame: 28th day
Modalities of the post-traumatic injury assessment by chest X-ray
Time frame: first 24 hours of hospitalization
Modalities of the post-traumatic injury assessment by pelvis X-ray
Time frame: first 24 hours of hospitalization
Modalities of the post-traumatic injury assessment by abdominal ultrasound
Time frame: first 24 hours of hospitalization
Modalities of the post-traumatic injury assessment by transcranial Doppler scan
Time frame: first 24 hours of hospitalization
Modalities of the post-traumatic injury assessment by CT scan
Time frame: first 24 hours of hospitalization
Modalities of the post-traumatic injury assessment by bone radiographs
Time frame: first 24 hours of hospitalization
Need for and timing of laparotomy
Time frame: 28th day
Need for and timing of hemostasis thoracotomy
Time frame: 28th day
Need for and timing of embolization
Time frame: 28th day
Need for and timing of craniectomy
Time frame: 28th day
Need for and timing of intracranial pressure measurement
Time frame: 28th day
Need for and timing of chest drainage
Time frame: 28th day
Distance to the nearest available pre-hospital medical facility
Time frame: 1 day
Length of mechanical ventilation
Time frame: 28th day
Length of hospital stay
Time frame: 28th day
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 10 Mar 2026.
- 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.
RAUX Mathieu, MD PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Triage in people with Wounds and Injuries, run by Assistance Publique - Hôpitaux de Paris at 1 site 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 1 inclusion and 3 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 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
28-day mortality (time frame: 28th day). 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 10 Mar 2026.