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RecruitingNCT06551350SAMU-TRAUMASUpdated Dec 5, 2024

Retrospective Assessment of Referral of a Major Trauma Patient

An observational study in Trauma Injury, sponsored by Hôpital NOVO. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-05.

Sponsored by Hôpital NOVO · Observational

From the registry’s dates

  • Primary completion was expected by May 2025, 1 year 5 months ago, but the record still lists the study as recruiting.
  • Started Oct 2024; still recruiting 1 year 11 months later.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
461
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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.

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Conditions studied

  • Trauma Injury

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Keywords

  • Major trauma
  • Mobile Intensive Care Unit (MCIU)
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In context

Wounds and Injuries

5,056 studies on the registry are indexed under Wounds and Injuries; 861 are open to participants now.

This study's planned enrollment of 461 is above the median of 135 across 1,597 observational studies indexed under Wounds and Injuries.

Browse Wounds and Injuries studies →

Lead sponsor

Hôpital NOVO is the lead sponsor of 69 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients regulated by SAMU 95 with suspected major trauma between the 1st January 2023 and the 31th December 2023.

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

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
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
461 participants (estimated)
Patient registry
No

Interventions

  • OtherData Collection

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

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What researchers measure

Primary outcomes

  1. Triage assessment of a major trauma patient

    The criterion is the evaluation of the referral of the major trauma patient after post-Medics injury assessment into over, normo and under-triage The over-triage patient is referred to a level I trauma centre with an Injury Severity Score (ISS) \<16 The normo-triage patients are either referred to: * a level 1 trauma centre with an ISS \>15 * the local scanner and then to an intensive care unit at the scanner site * in the emergency department and then to a surgical unit * emergency with a return home afterwards The under-triage patient is either referred to: * the local scanner and then to a level 1 trauma centre * initially emergency with hospitalisation in an intensive care or continuing care unit afterwards

    Time frame: At the end of the study, an average of 9 month

Secondary outcomes

  1. Assess if the intervention time is correlated with an under-triage

    The correlation will be assessed by the proportion of patients under-triaged during the following hours: * 7am to 9am * From 6pm to 9pm * From 9pm to 7am i.e. the ratio between the number of under-triaged patients and the number of major trauma patients treated during the defined time slots.

    Time frame: At the end of the study, an average of 9 month

  2. Assess if presumed alcohol intoxication is correlated with a higher rate of under-triage

    The correlation will be assessed by the proportion of patients under-triaged in patients with suspected alcohol intoxication. Presence of suspected alcohol intoxication assessed clinically i.e. the ratio between the number of under-triaged patients with suspected alcohol intoxication and the total number of major trauma patients

    Time frame: At the end of the study, an average of 9 month

  3. Assess if deliberate toxic poisoning is correlated with a higher rate of under-triage

    The correlation will be assessed by the proportion of patients under-triaged in patients with suspected deliberate toxic poisoning. Presence of deliberate toxic poisoning assessed clinically i.e. the ratio between the number of under-triaged patients with suspected deliberate toxic poisoning and the total number of major trauma patients

    Time frame: At the end of the study, an average of 9 month

  4. Assess if the TRENAU grade is predictive in pre-hospital of an appropriate referral following an intra-hospital trauma assessment

    The criterion will be assessed by the correlation between TRENAU grade and level of trauma centre for final admission : TRENAU A in a level 1 trauma centre TRENAU B in a level 2 trauma centre TRENAU C in a level 3 trauma centre The TRENAU grade (Trauma System du Réseau Nord Alpin des Urgences) is used to classify major trauma patients into 3 categories (A, B and C) in the pre-hospital phase, so that they can be referred to the appropriate level of hospital

    Time frame: At the end of the study, an average of 9 month

  5. Assess if the positive Shock-Index is predictive of an appropriate pre-hospital referral to a level 1 trauma centre

    The criterion will be assessed by the number of patient with positive Shock-Index (≥ 0.9) at the time of MCIU care referred to a level 1 trauma centre (final admission)

    Time frame: At the end of the study, an average of 9 month

  6. Assess if the positive Shock-Index ( ≥ 0.9 ) is predictive of an intra-hospital blood transfusion

    The criterion will be assessed by the number of patient with positive Shock-Index (≥ 0.9) at the time of MCIU care and who have had an intra-hospital blood transfusion

    Time frame: At the end of the study, an average of 9 month

  7. Assess if the MGAP is predictive of an appropriate referral following an intra-hospital trauma assessment

    The evaluation criterion will be assessed as follow : Number of patient with a MGAP between 23 and 29 and an final admission in a level 3 trauma centre Number of patient with a MGAP between 18 and 22 and an final admission in a level 2 trauma centre Number of patient with a MGAP \< 18 and an final admission in a level 3 trauma centre The MGAP score (Mechansim, Glasgow, Age, Arterial pressure) can predict the risk of in-hospital death in trauma patients. Three risk groups have been defined: low (23-29 points), intermediate (18-22 points) and high (\<18 points).

    Time frame: At the end of the study, an average of 9 month

07

Study locations

1 of 1 sites recruiting
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References and documents

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. PubMed 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, Hamadeh RR, Hijar M, Hu G, Jayaraman SP, Jiang G, Khader YS, Khan EA, Krishnaswami S, Kulkarni C, Lecky FE, Leung R, Lunevicius R, Lyons RA, Majdan M, Mason-Jones AJ, Matzopoulos R, Meaney PA, Mekonnen W, Miller TR, Mock CN, Norman RE, Orozco R, Polinder S, Pourmalek F, Rahimi-Movaghar V, Refaat A, Rojas-Rueda D, Roy N, Schwebel DC, Shaheen A, Shahraz S, Skirbekk V, Soreide K, Soshnikov S, Stein DJ, Sykes BL, Tabb KM, Temesgen AM, Tenkorang EY, Theadom AM, Tran BX, Vasankari TJ, Vavilala MS, Vlassov VV, Woldeyohannes SM, Yip P, Yonemoto N, Younis MZ, Yu C, Murray CJ, Vos T. The global burden of injury: incidence, mortality, disability-adjusted life years and time trends from the Global Burden of Disease study 2013. Inj Prev. 2016 Feb;22(1):3-18. doi: 10.1136/injuryprev-2015-041616. Epub 2015 Dec 3. PubMed 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 abstract available. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 4814394 ↗
  • Rating the severity of tissue damage. I. The abbreviated scale. JAMA. 1971 Jan 11;215(2):277-80. doi: 10.1001/jama.1971.03180150059012. No abstract available. PubMed 5107365 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06551350
Lead sponsor
Hôpital NOVO
Responsible party
Sponsor
First posted
Aug 13, 2024
Start date
Oct 18, 2024
Primary completion
May 2025 (estimated)
Completion
May 2025 (estimated)
Last update
Dec 5, 2024

Study contacts

Maryline DELATTRE
Contact
maryline.delattre@ght-novo.fr
+3333130754131
Véronique DA COSTA
Contact
veronique.dacosta@ght-novo.fr
+3333130755069
Fabrice LOUVET
principal investigator · Hôpital NOVO

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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