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Recruiting NCT06551350

Retrospective Assessment of Referral of a Major Trauma Patient

Observational Trauma Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Data Collection.
Who it may be relevant to
Registry conditions: Trauma Injury. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Retrospective Assessment of Referral of a Major Trauma Patient in Val-d'Oise

Overview

The aim of this study is to find out whether major trauma patients from the Val d'Oise are referred to the appropriate trauma centre for their care and to assess the quality of triage within the Val d'Oise department.

Detailed description

In France, the number of major trauma is estimated at between 15,000 and 20,000 per year. It is the leading cause of death in patients under the age of 40, and is a significant source of long-term dependency. Mortality from severe trauma varies depending on the region and the circumstances of the accident. Effective initial care and referral to specialist trauma centres are crucial to improving survival. Access to these centres must be guaranteed throughout France. Trauma centres play a central role in the management of serious trauma patients. They are classified by level, from level I to level III.

The triage process aims to direct the patient to the trauma centre with the appropriate level of care. The challenge is to send the "right patient to the right place at the right time". Over-triage and under-triage are two critical concepts in the management of trauma patients. Over-triage (patients considered to be more seriously injured than they really are) leads to excessive consumption of resources and increases waiting times for patients who really need a level I or II trauma centre. Under-triage (patients considered to be less seriously injured than they really are), is characterised by patients being referred to a trauma centre that is insufficiently equipped for their needs, compromises their chances of survival and recovery. In both cases, the loss of chance for the patient is real.

The aim of this study is to find out whether major trauma patients from the Val d'Oise are referred to the appropriate trauma centre for their care, and to assess the quality of triage within the Val d'Oise department.

Interventions

  • Other Data Collection
    Collection of medical data from MICU intervention file and the medical records of patients at the destination hospital

Primary outcome measures

  • Triage assessment of a major trauma patient [Time frame: At the end of the study, an average of 9 month]
Secondary outcome measures (7)
  • Assess if the intervention time is correlated with an under-triage [Time frame: At the end of the study, an average of 9 month]
  • Assess if presumed alcohol intoxication is correlated with a higher rate of under-triage [Time frame: At the end of the study, an average of 9 month]
  • Assess if deliberate toxic poisoning is correlated with a higher rate of under-triage [Time frame: At the end of the study, an average of 9 month]
  • Assess if the TRENAU grade is predictive in pre-hospital of an appropriate referral following an intra-hospital trauma assessment [Time frame: At the end of the study, an average of 9 month]
  • Assess if the positive Shock-Index is predictive of an appropriate pre-hospital referral to a level 1 trauma centre [Time frame: At the end of the study, an average of 9 month]
  • Assess if the positive Shock-Index ( ≥ 0.9 ) is predictive of an intra-hospital blood transfusion [Time frame: At the end of the study, an average of 9 month]
  • Assess if the MGAP is predictive of an appropriate referral following an intra-hospital trauma assessment [Time frame: At the end of the study, an average of 9 month]

Eligibility criteria

Inclusion criteria

  • Between the 1st January 2023 and the 31th December 2023
  • Regulated by SAMU 95 with suspected major trauma
  • Sending an MCIU
  • At least 1 Vittel criterion\*

Exclusion criteria

  • Death on site
  • Care by an MICU team outside the 95
  • Minor patients and legal protection
  • Transport refusals
  • Vittel criterion :
  • Physiological variables : Glasgow score < 13 Systolic blood pressure < 90 mmHg O2 saturation < 90%
  • Elements of kinetics : Ejection from a vehicle Other passenger killed in the same vehicle Fall > 6 metres Victim thrown or crushed Overall assessment (deformation of the vehicle, estimated speed, absence of helmet, absence of seatbelt) Blast
  • Anatomical lesions : Penetrating trauma to the head, neck, thorax, abdomen, pelvis, arm or thigh Flail chest Severe burn, smoke inhalation Pelvic fracture Suspected spinal cord injury Amputation of wrist, ankle or above Acute limb ischaemia
  • Pre-hospital resuscitation : Assisted ventilation Filling > 1000 ml with colloids Catecholamines Inflated shock-proof trousers
  • Medical context (to be assessed) : Age > 65 Cardiac or coronary insufficiency Respiratory insufficiency Pregnancy (2nd and 3rd trimesters) Blood crase disorders

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • Resuscitation Services (SAMU 95/SMUR) - Hôpital NOVO -Pontoise Site — Pontoise

Publications

  • MacKenzie EJ, Rivara FP, Jurkovich GJ, Nathens AB, Frey KP, Egleston BL, Salkever DS, Scharfstein DO. A national evaluation of the effect of trauma-center care on mortality. N Engl J Med. 2006 Jan 26;354(4):366-78. doi: 10.1056/NEJMsa052049. PMID 16436768
  • Haagsma JA, Graetz N, Bolliger I, Naghavi M, Higashi H, Mullany EC, Abera SF, Abraham JP, Adofo K, Alsharif U, Ameh EA, Ammar W, Antonio CA, Barrero LH, Bekele T, Bose D, Brazinova A, Catala-Lopez F, Dandona L, Dandona R, Dargan PI, De Leo D, Degenhardt L, Derrett S, Dharmaratne SD, Driscoll TR, Duan L, Petrovich Ermakov S, Farzadfar F, Feigin VL, Franklin RC, Gabbe B, Gosselin RA, Hafezi-Nejad N, PMID 26635210
  • Hirsch M, Carli P, Nizard R, Riou B, Baroudjian B, Baubet T, Chhor V, Chollet-Xemard C, Dantchev N, Fleury N, Fontaine JP, Yordanov Y, Raphael M, Burtz CP, Lafont A; health professionals of Assistance Publique-Hopitaux de Paris (APHP). The medical response to multisite terrorist attacks in Paris. Lancet. 2015 Dec 19;386(10012):2535-8. doi: 10.1016/S0140-6736(15)01063-6. Epub 2015 Nov 28. No abstra PMID 26628327
  • Cotte J, Courjon F, Beaume S, Prunet B, Bordes J, N'Guyen C, Contargyris C, Lacroix G, Montcriol A, Kaiser E, Meaudre E. Vittel criteria for severe trauma triage: Characteristics of over-triage. Anaesth Crit Care Pain Med. 2016 Apr;35(2):87-92. doi: 10.1016/j.accpm.2015.06.013. Epub 2015 Dec 1. PMID 26592159
  • Sartorius D, Le Manach Y, David JS, Rancurel E, Smail N, Thicoipe M, Wiel E, Ricard-Hibon A, Berthier F, Gueugniaud PY, Riou B. Mechanism, glasgow coma scale, age, and arterial pressure (MGAP): a new simple prehospital triage score to predict mortality in trauma patients. Crit Care Med. 2010 Mar;38(3):831-7. doi: 10.1097/CCM.0b013e3181cc4a67. PMID 20068467
  • Liao TK, Ho CH, Lin YJ, Cheng LC, Huang HY. Shock index to predict outcomes in patients with trauma following traffic collisions: a retrospective cohort study. Eur J Trauma Emerg Surg. 2024 Oct;50(5):2191-2198. doi: 10.1007/s00068-024-02545-4. Epub 2024 May 31. PMID 38819683
  • Bouzat P, Ageron FX, Brun J, Levrat A, Berthet M, Rancurel E, Thouret JM, Thony F, Arvieux C, Payen JF; TRENAU group. A regional trauma system to optimize the pre-hospital triage of trauma patients. Crit Care. 2015 Mar 18;19(1):111. doi: 10.1186/s13054-015-0835-7. PMID 25887150
  • Baker SP, O'Neill B, Haddon W Jr, Long WB. The injury severity score: a method for describing patients with multiple injuries and evaluating emergency care. J Trauma. 1974 Mar;14(3):187-96. No abstract available. PMID 4814394

Identifiers

NCT: NCT06551350 · CHRD0924

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗