An observational study in Trauma Injury, sponsored by University Hospital, Angers. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-27.
Sponsored by University Hospital, Angers · Observational
External validation of the clinical pre-hospital "Red- Flag" alert for activation of intra-hospital hemorrhage control response in blunt trauma.
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
3,000 studies on the registry are indexed under Hemorrhage; 474 are open to participants now.
This study's planned enrollment of 630 is above the median of 150 across 893 observational studies indexed under Hemorrhage.
Browse Hemorrhage studies →University Hospital, Angers is the lead sponsor of 464 studies on the registry; 116 are open to participants now.
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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.
Exclusion criteria:
Specific intra-hospital severe haemorrhage response
The main evaluation criterion is defined, as in the initial study by Hamada et al., by the presence of intrahospital criteria for severe hemorrhage justifying an immediate intrahospital action of hemostasis, defined by: * Red Blood Cell Concentrate transfusion required upon arrival at trauma center * Transfusion of at least 4 CGR within the first 6 hours of hospital management * Lactacidemy 5 mmol/L at first blood collection * Need for hemostasis surgery or radiology interventional prior to completion of a pan-body CT lesion assessment * Death from hemorrhagic shock within first 24 hours admission The ability of the RED-FLAG score to detect patients with severe hospital bleeding requiring immediate hemostasis action (as defined above) will be assessed by determining the area under the curve and its 95% CI of the ROC curve of this score.
Time frame: 24 hours
Comparison of the two RED-FLAG and BATT scores
We will compare the two BATT score and the RED-FLAG scores results and their possible correlation between. We will use the Pearson linear coefficient to make the comparison. The BATT (Bleeding Audit for Trauma \& Triage) score is a score with a minimum of 0 and a maximum of 27 points. Its identifies trauma patient at risk of significant haemorrhage. A score of 2 or more would be an appropriate threshold for pre-hospital tranexamic acid treatment. The RED-FLAG score is a score with a minimum of 0 and a maximum of 5 points. A score greater than or equal to 2 points identifies severe blunt trauma patients during the pre-hospital care phase and activating a specific immediate intra-hospital haemorrhage control response prior to arrival.
Time frame: 24 hours
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University Hospital, Angers