Retrospective Assessment of Referral of a Major Trauma Patient

NCT ID: NCT06551350

Last Updated: 2024-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

461 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-18

Study Completion Date

2025-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Trauma Injury

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Major trauma Mobile Intensive Care Unit (MCIU)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Data Collection

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hôpital NOVO

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Fabrice LOUVET

Role: PRINCIPAL_INVESTIGATOR

Hôpital NOVO

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Pontoise, , France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Maryline DELATTRE

Role: CONTACT

Phone: +3333130754131

Email: [email protected]

Véronique DA COSTA

Role: CONTACT

Phone: +3333130755069

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Dr Fabrice LOUVET

Role: primary

Pierre CHENEVIER

Role: backup

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 16436768 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26635210 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26628327 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26592159 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20068467 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38819683 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25887150 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 4814394 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 5107365 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

https://www.insee.fr/fr/statistiques

Insee. Statistiques sur les accidents En France.

https://www.santepubliquefrance.fr

Santé publique France. "Traumatismes non intentionnels." Bulletin épidémiologique hebdomadaire. 2023

https://www.santepubliquefrance.fr/maladies-et-traumatismes/traumatismes

Santé publique France. "Traumatismes et accidents de la vie courante." Publié le 6 mai 2022

https://dumas.ccsd.cnrs.fr/dumas-00631527

Thèse de Doctorat Université de Rennes 1

https://theses.hal.science/tel-03084258

Thèse de Doctorat en santé Publique - Epidémiologie. Université Paris-Saclay

https://dumas.ccsd.cnrs.fr/dumas-01119343

Thèse de Doctorat Université de Grenoble

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CHRD0924

Identifier Type: -

Identifier Source: org_study_id