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

NCT05820217 | Unknown

• 1 other identifier: RED-FLAG 2
• Study Type: observational
• Target: 630
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Trauma Injury

Keywords

Injury; Severe haemorrhage; Severe trauma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Comparison of the two RED-FLAG and BATT scores

  24 hours

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Angers: lead
• Rennes University Hospital: collaborator
• University Hospital, Tours: collaborator
• Hospital, Laval, France: collaborator
• Hospital, Le Mans, France: collaborator
• Hospital, Chambery, France: collaborator

Related Publications (13)

• 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.

  PMID: 28030708 RESULT

• 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.

  PMID: 10754963 RESULT

• 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.

  PMID: 7869433 RESULT

• 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.

  PMID: 31163036 RESULT

• 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.

  PMID: 7396078 RESULT

• 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.

  PMID: 8489391 RESULT

• 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.

  PMID: 18212658 RESULT

• 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.

  PMID: 27829100 RESULT

• 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.

  PMID: 19012550 RESULT

• 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.

  PMID: 32414401 RESULT

• 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.

  PMID: 29067429 RESULT

• 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.

  PMID: 29728151 RESULT

• 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.

  PMID: 33407716 RESULT

MeSH Terms

Conditions

Accidental Injuries; Wounds and Injuries; Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

François Morin, MD, MSc

CONTACT

0033241353715; francois.morin@chu-angers.fr

Dominique Savary, MD, PhD

CONTACT

0033241353715; Dominique.Savary@chu-angers.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2023
• First Posted: April 19, 2023
• Study Start: May 10, 2023
• Primary Completion: May 10, 2023
• Study Completion: December 31, 2024
• Last Updated: April 27, 2023

Record last verified: 2023-04