Traumatic InjuriesDELTA-91NCT07414186
Study of Pre Hospital Management of Polytrauma Patients by Medical Teams From a Department in the Parisian Region
An observational study of Traumatic Injuries and Prehospital Emergency Care, run by Centre Hospitalier Sud Francilien at 1 site in France.
Trial summary
To study the impact of prehospital management duration by SMUR teams in the Essonne department (91) on early patient mortality (within 24 hours) and to analyze the procedures performed on scene. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Traumatic Injuries, Prehospital Emergency Care, Early Mortality
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2026to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients managed prehospital by a SMUR team from the Essonne department (91) and transported to a Level 1 trauma center according to the predefined inclusion criteria
Who may be able to join
- Age ≥ 15 years (upper age limit for the pediatric population)
- Severe trauma, defined as any road traffic accident, defenestration, fall from a height greater than 3 meters, stab wound, or ballistic injury requiring medically supervised transport to one of the Level 1 trauma centers in the Île-de-France region
- Prehospital management provided by one of the SMUR teams in the Essonne department (91)
Who cannot join
- Patients declared dead at initial medical contact, without resuscitation initiated, or with resuscitation attempted and subsequently discontinued (non-return of spontaneous circulation)
- Secondary inter-hospital transfer from another hospital to a Level 1 trauma center
- Transport to a hospital for local computed tomography imaging only (without direct admission to a Level 1 trauma center)
- Cases regulated (dispatched) by emergency coordination centers other than the Essonne (91) medical dispatch center
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Centre Hospitalier Sud Francilien
Corbeil-Essonnes, 91106
Caroline TOURTE, 01 61 69 31 50 ext. +33, caroline.tourte@chsf.fr
Agathe LORINET, MD, agathe.lorinet@hotmail.fr
About this study
To study the impact of prehospital management duration by SMUR teams in the Essonne department (91) on early patient mortality (within 24 hours) and to analyze the procedures performed on scene.
The study hypothesis is that all-cause in-hospital mortality may be associated with the duration of prehospital care, with either a beneficial impact related to the performance of life-saving interventions or a negative impact due to prolonged time to access definitive treatment.
Identifying potential factors associated with prolonged prehospital management times could help define possible areas for improvement and future interventions.
Read the detailed description
Trauma is the leading cause of mortality among individuals aged 25-34 years, regardless of the mechanism of injury (road traffic accidents, falls from height, defenestration, ballistic or stab wounds, etc.).
More than 50% of trauma-related deaths occur within the first hour following injury, and over 80% occur within the first 24 hours.
Since the 1970s, the principle that definitive treatment should be initiated within one hour of the beginning of medical care for any life-threatening condition has been introduced. This concept, known as the "Golden Hour," has been applied in many fields, including trauma care, with the assumption that any delay is associated with decreased patient survival.
In the literature, prehospital time intervals do not consistently demonstrate a clear impact on mortality, with study results often being contradictory (1-11). A French study conducted within a SMUR-type system by Tobias Gauss in 2019 reported a significant linear increase in mortality associated with longer prehospital time (1).
In contrast, other American and European studies (3,7) did not find a significant association between prehospital care time and short- or long-term mortality, in healthcare systems that are not always comparable to the French SMUR model.
Overall, studies on this topic have yielded heterogeneous and sometimes conflicting results.
Nevertheless, these time intervals appear to play a more critical role in patients with penetrating trauma or with initial arterial hypotension.
The major challenge in the prehospital setting is therefore to rapidly identify patients for whom prolonged on-scene management would have a detrimental impact on survival.
The physician must then determine the optimal amount of time to spend at the scene during SMUR intervention, based on the risk-benefit balance for the patient.
Some patients will require longer prehospital management in order to perform life-saving procedures, whereas for others, for whom definitive treatment is exclusively hospital-based, any delay will be unacceptable.
- Keywords
- prehospital emergency care, emergency medical services, wounds and injuries, trauma severity, time-to-treatment, on-scene time, early mortality, in-hospital mortality, advanced life support, emergency medical procedures
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Patients managed prehospital by a SMUR team from the Essonne department (91) and transported to a Le | Patients managed prehospital by a SMUR team from the Essonne department (91) and transported to a Level 1 trauma center according to the predefined inclusion criteria. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
All-cause in-hospital mortality within 24 hours
Measured: at day 0
Secondary outcomes (1)
Length of hospital stay and neurological outcome
Total duration of hospital stay (in days) and neurological outcome at hospital discharge.
Measured: Up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start1 Mar 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic InjuriesStudies 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
- Retrospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Sud Francilien
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Romain BARDELAY, MD, Principal investigator, Centre Hospitalier Sud Francilien
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07414186
- Sponsor's protocol ID
- 2025/0016
- Acronym
- DELTA-91
- Status last verified
- Jan 2026
- First submitted
- 28 Jan 2026
- Last updated
- 17 Feb 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 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Pre Hospital Management of Polytrauma Patients by Medical Teams From a Department in the Parisian Region
- ClinicalTrials.gov ID
- NCT07414186
- Acronym / sponsor ID
- DELTA-91 / 2025/0016
- Keywords
- prehospital emergency care, emergency medical services, wounds and injuries, trauma severity, time-to-treatment, on-scene time, early mortality, in-hospital mortality
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Centre Hospitalier Sud FrancilienUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 17 Feb 2026 (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.
To study the impact of prehospital management duration by SMUR teams in the Essonne department (91) on early patient mortality (within 24 hours) and to analyze the procedures performed on scene.
The study hypothesis is that all-cause in-hospital mortality may be associated with the duration of prehospital care, with either a beneficial impact related to the performance of life-saving interventions or a negative impact due to prolonged time to access definitive treatment.
Identifying potential factors associated with prolonged prehospital management times could help define possible areas for improvement and future interventions.
Detailed description
Trauma is the leading cause of mortality among individuals aged 25-34 years, regardless of the mechanism of injury (road traffic accidents, falls from height, defenestration, ballistic or stab wounds, etc.).
More than 50% of trauma-related deaths occur within the first hour following injury, and over 80% occur within the first 24 hours.
Since the 1970s, the principle that definitive treatment should be initiated within one hour of the beginning of medical care for any life-threatening condition has been introduced. This concept, known as the "Golden Hour," has been applied in many fields, including trauma care, with the assumption that any delay is associated with decreased patient survival.
In the literature, prehospital time intervals do not consistently demonstrate a clear impact on mortality, with study results often being contradictory (1-11). A French study conducted within a SMUR-type system by Tobias Gauss in 2019 reported a significant linear increase in mortality associated with longer prehospital time (1).
In contrast, other American and European studies (3,7) did not find a significant association between prehospital care time and short- or long-term mortality, in healthcare systems that are not always comparable to the French SMUR model.
Overall, studies on this topic have yielded heterogeneous and sometimes conflicting results.
Nevertheless, these time intervals appear to play a more critical role in patients with penetrating trauma or with initial arterial hypotension.
The major challenge in the prehospital setting is therefore to rapidly identify patients for whom prolonged on-scene management would have a detrimental impact on survival.
The physician must then determine the optimal amount of time to spend at the scene during SMUR intervention, based on the risk-benefit balance for the patient.
Some patients will require longer prehospital management in order to perform life-saving procedures, whereas for others, for whom definitive treatment is exclusively hospital-based, any delay will be unacceptable.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients managed prehospital by a SMUR team from the Essonne department (91) and transported to a Le | – | –Patients managed prehospital by a SMUR team from the Essonne department (91) and transported to a Level 1 trauma center according to the predefined inclusion criteria. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients managed prehospital by a SMUR team from the Essonne department (91) and transported to a Level 1 trauma center according to the predefined inclusion criteria
Key inclusion criteria (3 listed)
- Age ≥ 15 years (upper age limit for the pediatric population)
- Severe trauma, defined as any road traffic accident, defenestration, fall from a height greater than 3 meters, stab wound, or ballistic injury requiring medically supervised transport to one of the Level 1 trauma centers in the Île-de-France region
- Prehospital management provided by one of the SMUR teams in the Essonne department (91)
Key exclusion criteria (4 listed)
- Patients declared dead at initial medical contact, without resuscitation initiated, or with resuscitation attempted and subsequently discontinued (non-return of spontaneous circulation)
- Secondary inter-hospital transfer from another hospital to a Level 1 trauma center
- Transport to a hospital for local computed tomography imaging only (without direct admission to a Level 1 trauma center)
- Cases regulated (dispatched) by emergency coordination centers other than the Essonne (91) medical dispatch center
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality
Time frame: at day 0
All-cause in-hospital mortality within 24 hours
1 secondary outcome
Length of hospital stay and neurological outcome
Time frame: Up to one year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 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.
Romain BARDELAY, MD principal investigator
Centre Hospitalier Sud Francilien
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Injuries and Prehospital Emergency Care, run by Centre Hospitalier Sud Francilien 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 3 inclusion and 4 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: opening soon, as of the sponsor's last update on 17 Feb 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Romain BARDELAY, MD (01 61 69 31 50 ext. +33, r.bardelay@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: at day 0). 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 17 Feb 2026.