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

NCT ID: NCT05820217

Last Updated: 2023-04-27

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 630 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-05-10
• Study Completion Date: 2024-12-31

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

Conditions

Trauma Injury

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rennes University Hospital

OTHER

Sponsor Role: collaborator

University Hospital, Tours

OTHER

Sponsor Role: collaborator

Hospital, Laval, France

UNKNOWN

Sponsor Role: collaborator

Hospital, Le Mans, France

UNKNOWN

Sponsor Role: collaborator

Hospital, Chambery, France

UNKNOWN

Sponsor Role: collaborator

University Hospital, Angers

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

François Morin, MD, MSc

Role: CONTACT

francois.morin@chu-angers.fr

0033241353715

Dominique Savary, MD, PhD

Role: CONTACT

Dominique.Savary@chu-angers.fr

0033241353715

References

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.

Reference Type: RESULT

PMID: 28030708 (View on PubMed)

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.

Reference Type: RESULT

PMID: 10754963 (View on PubMed)

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.

Reference Type: RESULT

PMID: 7869433 (View on PubMed)

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.

Reference Type: RESULT

PMID: 31163036 (View on PubMed)

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.

Reference Type: RESULT

PMID: 7396078 (View on PubMed)

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.

Reference Type: RESULT

PMID: 8489391 (View on PubMed)

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.

Reference Type: RESULT

PMID: 18212658 (View on PubMed)

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.

Reference Type: RESULT

PMID: 27829100 (View on PubMed)

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.

Reference Type: RESULT

PMID: 19012550 (View on PubMed)

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.

Reference Type: RESULT

PMID: 32414401 (View on PubMed)

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.

Reference Type: RESULT

PMID: 29067429 (View on PubMed)

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.

Reference Type: RESULT

PMID: 29728151 (View on PubMed)

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.

Reference Type: RESULT

PMID: 33407716 (View on PubMed)

Other Identifiers

RED-FLAG 2

Identifier Type: -

Identifier Source: org_study_id