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

NCT04275791 | Completed

• 1 other identifier: APHP180625
• Study Type: interventional
• Target: 2,193
• Locations: 1 country
• Sites: 1

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.

Conditions

Wounds and Injuries

Keywords

Advanced Trauma Life Support Care; Trauma Severity Indices; Trauma Centers; Triage

Outcome Measures

Primary Outcomes (1)

• 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.

  28th day

Secondary Outcomes (22)

• Undertriage

  28th day

• Over-triage

  28th day

• Transfer to a trauma centre

  1 day

• Secondary inter-hospital transfer

  28th day

• Days living without mechanical ventilation

  28th day

Study Arms (2)

hierarchized

EXPERIMENTAL

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

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).

Interventions

Triage OTHER

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.

hierarchized

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Pitié-Salpetrière

Paris, France

Location

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Triage

Intervention Hierarchy (Ancestors)

Emergency Medical Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• RAUX Mathieu, MD PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2020
• First Posted: February 19, 2020
• Study Start: May 23, 2022
• Primary Completion: December 31, 2023
• Study Completion: January 28, 2024
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)