NCT06551350

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
461

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 13, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

October 18, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

December 5, 2024

Status Verified

December 1, 2024

Enrollment Period

7 months

First QC Date

August 9, 2024

Last Update Submit

December 4, 2024

Conditions

Keywords

Major traumaMobile Intensive Care Unit (MCIU)

Outcome Measures

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

    At the end of the study, an average of 9 month

Secondary Outcomes (7)

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

    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

    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

    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

    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

    At the end of the study, an average of 9 month

  • +2 more secondary outcomes

Interventions

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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\*

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Resuscitation Services (SAMU 95/SMUR) - Hôpital NOVO -Pontoise Site

Pontoise, 95300, France

RECRUITING

Related Publications (9)

  • 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: 16436768BACKGROUND
  • 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.

    PMID: 26635210BACKGROUND
  • 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.

    PMID: 26628327BACKGROUND
  • 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: 26592159BACKGROUND
  • 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: 20068467BACKGROUND
  • 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: 38819683BACKGROUND
  • 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: 25887150BACKGROUND
  • 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: 4814394BACKGROUND
  • 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.

    PMID: 5107365BACKGROUND

Related Links

MeSH Terms

Conditions

Accidental Injuries

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Epidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Fabrice LOUVET

    Hôpital NOVO

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2024

First Posted

August 13, 2024

Study Start

October 18, 2024

Primary Completion

May 1, 2025

Study Completion

May 1, 2025

Last Updated

December 5, 2024

Record last verified: 2024-12

Locations