Clinical trial NCT05820217: External Validation of the Clinical Pre-hospital "Red- Flag" Alert for Activation of Intra-hospital Hemorrhage Control Response in Blunt Trauma.
Official title: External Validation of the Clinical Pre-hospital "Red- Flag" Alert for Activation of Intra-hospital Hemorrhage Control Response in Blunt Trauma. A Prospective Multicentric Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Trauma Injury
Keywords: Injury
Severe haemorrhage
Severe trauma
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
Collaborators: name: Rennes University Hospital
name: University Hospital, Tours
name: Hospital, Laval, France
name: Hospital, Le Mans, France
name: Hospital, Chambery, France
First posted: 2023-04-19
Enrollment: 630
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: In France, the pre-hospital response system is organised. Any traumatized patient or witness of a trauma has the opportunity to request health assistance by calling the "15 emergency number". Under medical regulation, the emergency physician will hire pre-hospital road and/or helicopter medical means in order to medically and quickly take care of these patients.

The collections of information will then be made by 6 centers

This population of severely traumatized patients supported by medicalized Mobile Emergency and Resuscitation Facilities (SMUR) will be our study population. A systematic collection of information from these patients will be collected prospectively using a SMUR sheet.

Brief summary: External validation of the clinical pre-hospital "Red- Flag" alert for activation of intra-hospital hemorrhage control response in blunt trauma.

Detailed description: Severe trauma, with a variety of causes, is responsible for more than 9% of the world's population and is the leading cause of preventable mortality among 15-35 year olds. Massive hemorrhage remains the second leading cause of early mortality in those traumatized after head trauma, accounting for about 40% of deaths. In 71% of cases this mortality is pre-hospital without access to rapid medicalization. Intra-hospital mortality is also important.

The main factors explaining this mortality in patients with severe bleeding are delays in recognition and management. The effectiveness of the "trauma systems" and the management channels for severe traumatized injuries are thus generally assessed by the intra-hospital mortality rate. Optimal and early management is therefore essential from the pre-hospital phase.

The treatment of traumatic hemorrhagic shock requires means of local hemostasis, medication management and can go as far as the establishment of massive transfusion protocols (PTM). This type of PTM is activated in about 8% of cases. While it is little practiced in pre-hospital and still debated today, its early hospital establishment is essential.

Rym Hamada et al. highlighted a predictive score "RED-FLAG" of severe hemorrhage in severe traumatized patients requiring the immediate implementation of rapid hemorrhage control (activation of PTM, hemostasis surgery, etc.).

This score is based on 5 clinico-biological items. A score of 2 or more is predictive of an immediate intra-hospital action of hemostasis. In France, several networks are organized around centers 15 and hospitals specialized in the management of severe traumatized, from alert to definitive treatment, in accordance with the international recommendations in force.

The objective of this study is to perform external and prospective validation, within a new cohort, of the "RED-FLAGS" score. For this, we are conducting a multicenter and prospective study

Eligibility criteria: Inclusion Criteria:

* Adult patients (More than 18 yo)
* Regulated by the medical regulation centers (SAMU - centres 15) of the hospitals of Angers (SAMU 49), Rennes (SAMU 35), Le Mans (SAMU 72), Tours (SAMU 37), Laval (SAMU 53) and Chambéry (SAMU 73)
* Patients with severe trauma classified as A or B
* And benefiting respectively from hospital support in trauma centers
* Not subject to limitation of active therapeutics
* Member or beneficiary of a social security scheme

Exclusion criteria:

* Patients with Not Considered Severe Trauma (Not A, B or C) after pre-hospital medical assessment
* Patient objecting to participating in research

Primary outcomes:
measure: Specific intra-hospital severe haemorrhage response
timeFrame: 24 hours
Secondary outcomes:
measure: Comparison of the two RED-FLAG and BATT scores
timeFrame: 24 hours
Other outcomes:
Locations:
Study officials:
References:
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