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

Primary Purpose

Wounds and Injuries

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Triage
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wounds and Injuries focused on measuring Advanced Trauma Life Support Care, Trauma Severity Indices, Trauma Centers, Triage

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Hôpital Pitié-SalpetrièreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

hierarchized

all-or-nothing

Arm Description

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

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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
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;
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;
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;
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;
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;
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
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
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
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
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
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;
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;
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;
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;
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;
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;
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;
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.
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;
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;

Full Information

First Posted
January 31, 2020
Last Updated
May 26, 2023
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT04275791
Brief Title
Assessment of the Benefit of an Inclusive Health Organization on the Prognosis of Severe Trauma Patients
Acronym
TRAUMINXCLUSIF
Official Title
Assessment of the Benefit of an Inclusive Health Organization on the Prognosis of Severe Trauma Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 23, 2022 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wounds and Injuries
Keywords
Advanced Trauma Life Support Care, Trauma Severity Indices, Trauma Centers, Triage

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
2500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
hierarchized
Arm Type
Experimental
Arm Description
Structured regional health organization, composed of trauma centers hierarchized in several levels according to their capacity to receive severe traumatized persons.
Arm Title
all-or-nothing
Arm Type
No Intervention
Arm 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).
Intervention Type
Other
Intervention Name(s)
Triage
Intervention Description
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.
Primary Outcome Measure Information:
Title
28-day mortality
Description
The primary endpoint will be 28-day mortality, defined as the occurrence of death from any cause within the first 28 days following trauma.
Time Frame
28th day
Secondary Outcome Measure Information:
Title
Undertriage
Description
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.
Time Frame
28th day
Title
Over-triage
Description
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
Time Frame
28th day
Title
Transfer to a trauma centre
Description
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;
Time Frame
1 day
Title
Secondary inter-hospital transfer
Description
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;
Time Frame
28th day
Title
Days living without mechanical ventilation
Description
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;
Time Frame
28th day
Title
Days living without resuscitation
Description
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;
Time Frame
28th day
Title
Length of stay in resuscitation
Description
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;
Time Frame
28th day
Title
Modalities of the post-traumatic injury assessment by chest X-ray
Description
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
Time Frame
first 24 hours of hospitalization
Title
Modalities of the post-traumatic injury assessment by pelvis X-ray
Description
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
Time Frame
first 24 hours of hospitalization
Title
Modalities of the post-traumatic injury assessment by abdominal ultrasound
Description
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
Time Frame
first 24 hours of hospitalization
Title
Modalities of the post-traumatic injury assessment by transcranial Doppler scan
Description
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
Time Frame
first 24 hours of hospitalization
Title
Modalities of the post-traumatic injury assessment by CT scan
Description
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
Time Frame
first 24 hours of hospitalization
Title
Modalities of the post-traumatic injury assessment by bone radiographs
Description
This criterion will be assessed at the end of the first 24 hours of hospitalization. This evaluation will include guided bone radiographs;
Time Frame
first 24 hours of hospitalization
Title
Need for and timing of laparotomy
Description
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;
Time Frame
28th day
Title
Need for and timing of hemostasis thoracotomy
Description
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;
Time Frame
28th day
Title
Need for and timing of embolization
Description
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;
Time Frame
28th day
Title
Need for and timing of craniectomy
Description
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;
Time Frame
28th day
Title
Need for and timing of intracranial pressure measurement
Description
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;
Time Frame
28th day
Title
Need for and timing of chest drainage
Description
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;
Time Frame
28th day
Title
Distance to the nearest available pre-hospital medical facility
Description
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.
Time Frame
1 day
Title
Length of mechanical ventilation
Description
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;
Time Frame
28th day
Title
Length of hospital stay
Description
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;
Time Frame
28th day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
RAUX Mathieu, MD PhD
Phone
+33142177204
Email
mathieu.raux@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
RAUX Mathieu, MD PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Pitié-Salpetrière
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
RAUX Mathieu, MD PhD
Phone
0142177204
Ext
+33
Email
mathieu.raux@aphp.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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