Assessment of the Benefit of an Inclusive Health Organization on the Prognosis of Severe Trauma Patients (TRAUMINXCLUSIF)

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Wounds and Injuries

Treatments: Other: Triage

Study type: Interventional

Funder types: Other

Identifiers

NCT04275791

APHP180625

Details and patient eligibility

About

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.

Full 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).

Enrollment: 2,500 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2,500 participants in 2 patient groups

hierarchized

Experimental group

Description:

Structured regional health organization, composed of trauma centers hierarchized in several levels according to their capacity to receive severe traumatized persons.

Treatment:

Other: Triage

all-or-nothing

No Intervention group

Description:

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).