External Validation of the Clinical Pre-hospital "Red- Flag" Alert for Activation of Intra-hospital Hemorrhage Control Response in Blunt Trauma. (RED-FLAG 2)

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Trauma Injury

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

• Study Type: Observational
• Enrollment (Anticipated): 630

Contacts and Locations

• Study Contact: Name: François Morin, MD, MSc; Phone Number: 0033241353715; Email: francois.morin@chu-angers.fr
• Study Contact Backup: Name: Dominique Savary, MD, PhD; Phone Number: 0033241353715; Email: Dominique.Savary@chu-angers.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 hours

Collaborators and Investigators

• Sponsor: University Hospital, Angers
• Collaborators: Rennes University Hospital; University Hospital, Tours; Hospital, Laval, France; Hospital, Le Mans, France; Hospital, Chambery, France

Publications and helpful links

General Publications

• Krug EG, Sharma GK, Lozano R. The global burden of injuries. Am J Public Health. 2000 Apr;90(4):523-6. doi: 10.2105/ajph.90.4.523.
• Shackford SR, Mackersie RC, Holbrook TL, Davis JW, Hollingsworth-Fridlund P, Hoyt DB, Wolf PL. The epidemiology of traumatic death. A population-based analysis. Arch Surg. 1993 May;128(5):571-5. doi: 10.1001/archsurg.1993.01420170107016.
• Davis KA, Fabian TC, Cioffi WG. The Toll of Death and Disability From Traumatic Injury in the United States-The "Neglected Disease" of Modern Society, Still Neglected After 50 Years. JAMA Surg. 2017 Mar 1;152(3):221-222. doi: 10.1001/jamasurg.2016.4625. No abstract available.
• Sauaia A, Moore FA, Moore EE, Moser KS, Brennan R, Read RA, Pons PT. Epidemiology of trauma deaths: a reassessment. J Trauma. 1995 Feb;38(2):185-93. doi: 10.1097/00005373-199502000-00006.
• Beck B, Smith K, Mercier E, Gabbe B, Bassed R, Mitra B, Teague W, Siedenburg J, McLellan S, Cameron P. Differences in the epidemiology of out-of-hospital and in-hospital trauma deaths. PLoS One. 2019 Jun 4;14(6):e0217158. doi: 10.1371/journal.pone.0217158. eCollection 2019.
• Baker CC, Oppenheimer L, Stephens B, Lewis FR, Trunkey DD. Epidemiology of trauma deaths. Am J Surg. 1980 Jul;140(1):144-50. doi: 10.1016/0002-9610(80)90431-6.
• Teixeira PG, Inaba K, Hadjizacharia P, Brown C, Salim A, Rhee P, Browder T, Noguchi TT, Demetriades D. Preventable or potentially preventable mortality at a mature trauma center. J Trauma. 2007 Dec;63(6):1338-46; discussion 1346-7. doi: 10.1097/TA.0b013e31815078ae.
• Moore L, Stelfox HT, Evans D, Hameed SM, Yanchar NL, Simons R, Kortbeek J, Bourgeois G, Clement J, Turgeon AF, Lauzier F. Trends in Injury Outcomes Across Canadian Trauma Systems. JAMA Surg. 2017 Feb 1;152(2):168-174. doi: 10.1001/jamasurg.2016.4212.
• Cameron PA, Gabbe BJ, Cooper DJ, Walker T, Judson R, McNeil J. A statewide system of trauma care in Victoria: effect on patient survival. Med J Aust. 2008 Nov 17;189(10):546-50. doi: 10.5694/j.1326-5377.2008.tb02176.x.
• Abe T, Komori A, Shiraishi A, Sugiyama T, Iriyama H, Kainoh T, Saitoh D. Trauma complications and in-hospital mortality: failure-to-rescue. Crit Care. 2020 May 15;24(1):223. doi: 10.1186/s13054-020-02951-1.
• Shackelford SA, Del Junco DJ, Powell-Dunford N, Mazuchowski EL, Howard JT, Kotwal RS, Gurney J, Butler FK Jr, Gross K, Stockinger ZT. Association of Prehospital Blood Product Transfusion During Medical Evacuation of Combat Casualties in Afghanistan With Acute and 30-Day Survival. JAMA. 2017 Oct 24;318(16):1581-1591. doi: 10.1001/jama.2017.15097.
• Hamada SR, Rosa A, Gauss T, Desclefs JP, Raux M, Harrois A, Follin A, Cook F, Boutonnet M; Traumabase(R) Group; Attias A, Ausset S, Boutonnet M, Dhonneur G, Duranteau J, Langeron O, Paugam-Burtz C, Pirracchio R, de St Maurice G, Vigue B, Rouquette A, Duranteau J. Development and validation of a pre-hospital "Red Flag" alert for activation of intra-hospital haemorrhage control response in blunt trauma. Crit Care. 2018 May 5;22(1):113. doi: 10.1186/s13054-018-2026-9.
• Ageron FX, Coats TJ, Darioli V, Roberts I. Validation of the BATT score for prehospital risk stratification of traumatic haemorrhagic death: usefulness for tranexamic acid treatment criteria. Scand J Trauma Resusc Emerg Med. 2021 Jan 6;29(1):6. doi: 10.1186/s13049-020-00827-5.

Study record dates

Study Major Dates

• Study Start (Anticipated): May 10, 2023
• Primary Completion (Anticipated): May 10, 2023
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: March 24, 2023
• First Submitted That Met QC Criteria: April 6, 2023
• First Posted (Actual): April 19, 2023

Study Record Updates

• Last Update Posted (Actual): April 27, 2023
• Last Update Submitted That Met QC Criteria: April 26, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Injury; Severe trauma; Severe haemorrhage
• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Hemorrhage
• Other Study ID Numbers: RED-FLAG 2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No