Clinical trial NCT04275791: Assessment of the Benefit of an Inclusive Health Organization on the Prognosis of Severe Trauma Patients
Official title: Assessment of the Benefit of an Inclusive Health Organization on the Prognosis of Severe Trauma Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wounds and Injuries
Keywords: Advanced Trauma Life Support Care
Trauma Severity Indices
Trauma Centers
Triage
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2020-02-19
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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).

Eligibility criteria: Inclusion Criteria:

- 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.

Exclusion Criteria:

* 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)

Primary outcomes:
measure: 28-day mortality
timeFrame: 28th day
Secondary outcomes:
measure: Undertriage
timeFrame: 28th day
measure: Over-triage
timeFrame: 28th day
measure: Transfer to a trauma centre
timeFrame: 1 day
measure: Secondary inter-hospital transfer
timeFrame: 28th day
measure: Days living without mechanical ventilation
timeFrame: 28th day
measure: Days living without resuscitation
timeFrame: 28th day
measure: Length of stay in resuscitation
timeFrame: 28th day
measure: Modalities of the post-traumatic injury assessment by chest X-ray
timeFrame: first 24 hours of hospitalization
measure: Modalities of the post-traumatic injury assessment by pelvis X-ray
timeFrame: first 24 hours of hospitalization
measure: Modalities of the post-traumatic injury assessment by abdominal ultrasound
timeFrame: first 24 hours of hospitalization
measure: Modalities of the post-traumatic injury assessment by transcranial Doppler scan
timeFrame: first 24 hours of hospitalization
measure: Modalities of the post-traumatic injury assessment by CT scan
timeFrame: first 24 hours of hospitalization
measure: Modalities of the post-traumatic injury assessment by bone radiographs
timeFrame: first 24 hours of hospitalization
measure: Need for and timing of laparotomy
timeFrame: 28th day
measure: Need for and timing of hemostasis thoracotomy
timeFrame: 28th day
measure: Need for and timing of embolization
timeFrame: 28th day
measure: Need for and timing of craniectomy
timeFrame: 28th day
measure: Need for and timing of intracranial pressure measurement
timeFrame: 28th day
measure: Need for and timing of chest drainage
timeFrame: 28th day
measure: Distance to the nearest available pre-hospital medical facility
timeFrame: 1 day
measure: Length of mechanical ventilation
timeFrame: 28th day
measure: Length of hospital stay
timeFrame: 28th day
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Pitié-Salpetrière
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: RAUX Mathieu, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: