Trauma InjuryRED-FLAG 2NCT05820217
External Validation of the Clinical Pre-hospital "Red- Flag" Alert for Activation of Intra-hospital Hemorrhage Control Response in Blunt Trauma.
An observational study of Trauma Injury, run by University Hospital, Angers.
Trial summary
External validation of the clinical pre-hospital "Red- Flag" alert for activation of intra-hospital hemorrhage control response in blunt trauma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trauma Injury
- How many people
- 630 participants
- Where
- No sites listed yet
- Study dates
- 10 May 2023to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Patients with Not Considered Severe Trauma (Not A, B or C) after pre-hospital medical assessment
- Patient objecting to participating in research
Trial locations and contacts
No sites are listed yet.
About this study
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
External validation of the clinical pre-hospital "Red- Flag" alert for activation of intra-hospital hemorrhage control response in blunt trauma.
Read the 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
- Keywords
- Injury, Severe haemorrhage, Severe trauma
- Medical subject headings
- Accidental Injuries, Wounds and Injuries, Hemorrhage
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours
Secondary outcomes (1)
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.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start10 May 2023 (estimated)
- Primary completion10 May 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Trauma InjuryStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 630 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Collaborators
- Rennes University Hospital, University Hospital, Tours, Hospital, Laval, France, Hospital, Le Mans, France, Hospital, Chambery, France
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05820217
- Sponsor's protocol ID
- RED-FLAG 2
- Acronym
- RED-FLAG 2
- Status last verified
- Apr 2023
- First submitted
- 24 Mar 2023
- Last updated
- 27 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 28030708Krug 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.
PubMed 10754963Sauaia 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.
PubMed 7869433Beck 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.
PubMed 31163036Baker 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.
PubMed 7396078Shackford 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.
PubMed 8489391Teixeira 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.
PubMed 18212658Moore 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.
PubMed 27829100Cameron 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.
PubMed 19012550Abe 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.
PubMed 32414401Shackelford 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.
PubMed 29067429Hamada 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.
PubMed 29728151Ageron 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.
PubMed 33407716
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05820217
- Acronym / sponsor ID
- RED-FLAG 2 / RED-FLAG 2
- Conditions
- Trauma Injury
- Keywords
- Injury, Severe haemorrhage, Severe trauma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 630 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Collaborators
- Rennes University Hospital, University Hospital, Tours, Hospital, Laval, France, Hospital, Le Mans, France, Hospital, Chambery, France
- Study start
- 10 May 2023 (estimated)
- Primary completion
- 10 May 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 19 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Patients with Not Considered Severe Trauma (Not A, B or C) after pre-hospital medical assessment
- Patient objecting to participating in research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Specific intra-hospital severe haemorrhage response
Time frame: 24 hours
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.
1 secondary outcome
Comparison of the two RED-FLAG and BATT scores
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2023.
- Results publication: PubMed 28030708Davis 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.
- Results publication: PubMed 10754963Krug 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.
- Results publication: PubMed 7869433Sauaia 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.
- Results publication: PubMed 31163036Beck 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.
- Results publication: PubMed 7396078Baker 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.
- Results publication: PubMed 8489391Shackford 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.
- Results publication: PubMed 18212658Teixeira 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.
- Results publication: PubMed 27829100Moore 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.
- Results publication: PubMed 19012550Cameron 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.
- Results publication: PubMed 32414401Abe 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.
- Results publication: PubMed 29067429Shackelford 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.
- Results publication: PubMed 29728151Hamada 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Trauma Injury, run by University Hospital, Angers.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact François Morin, MD, MSc (0033241353715, francois.morin@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Specific intra-hospital severe haemorrhage response (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05820217, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2023.