Trauma InjuryTRAPNCT06494293
How Many Patients Suffering Major Trauma Would be Eligible for a Pre-hospital Transfusion
An observational study of Trauma Injury, run by Hôpital NOVO at 4 sites in France.
Trial summary
The aim of the study is to measure the number of patients being cared for by a medical team for major trauma who could benefit from a transfusion labile blood products and thus provide a scientific argument in favour of supplying labile blood products to pre-hospital Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trauma Injury
- What is being tested?
- Data Collection
- How many people
- 200 participants
- Where
- 4 sitesFrance
- Study dates
- Apr 2025to May 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: Patients being cared for by a medical team for major trauma requiring transport to an emergency/recovery unit or declared dead during care between the 1st January 2023 and the 31th December 2023.
Who may be able to join
- Patients over 18
- Taken care of by a MICU team from participating centres
- Victims of major trauma requiring transport to an emergency/recovery unit or declared dead during care
- Informed and did not object to the collection of his data for research purposes during his lifetime
Who cannot join
- Traumatological reason for departure not confirmed in the emergency medical services report
- Patient care of by the MICU for secondary transport (transport from one hospital to another)
- Patient died without resuscitation by a professional
- Patient with manifest isolated closed head injury
- Patient deprived of civil rights
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites
Resuscitation Services (SMUR) Ballanger - Centre Hospitalier Intercommunal Robert Ballanger
Aulnay-sous-Bois, 93600
Dr Valérie RAPHAEL, valerie.raphael@ght-gpne.fr
Resuscitation Services (SAMU/SMUR) - Hôpital NOVO -Beaumont/Oise Site
Beaumont-sur-Oise, 95260
Dr Dorian WOLFF, +33 1 39 37 35 12, dorian.wolff@ght-novo.fr
Resuscitation Services (SAMU/SMUR) - Hôpital NOVO -Pontoise Site
Pontoise, 95300
Dr Dorian WOLFF, +33 1 30 75 40 15, dorian.wolff@ght-novo.fr
Resuscitation Services (SMUR) Delafontaine - Centre Hospitalier de Saint-Denis
Saint-Denis, 93000
Dr Brigitte Hennequin, Brigitte.hennequin@ch-stdenis.fr
About this study
Official title: How Many Patients Suffering Major Trauma Would be Eligible for a Pre-hospital Transfusion: A Multicentre Retrospective Study.
The aim of the study is to measure the number of patients being cared for by a medical team for major trauma who could benefit from a transfusion labile blood products and thus provide a scientific argument in favour of supplying labile blood products to pre-hospital
Read the detailed description
In France, pre-hospital resuscitation of major trauma patients does not use labile blood products, except in exceptional circumstances. The physician staffed Mobile Intensive Care Unit (MICU) are not equipped with this type of product. The first cause of death compatible with survival in the event of pre-hospital treatment identified in major trauma in war medicine is exsanguination. Mortality in haemorrhagic shock occurs rapidly and appears to be significantly reduced if transfusions are performed early. Early transfusion has proved its worth in the military context, leading the armed forces health service to recommend transfusion as a first-line treatment as quickly as possible, from the moment the patient is taken into care on the battlefield. More recently, in the North American civilian pre-hospital setting, the PAMPer study included 501 patients, 230 of whom were transfused with fresh frozen plasma (FFP - 2 units). The authors reported a significant reduction in mortality at D+30 in the FFP group (23.2% vs 33%; p=0.03). It therefore seems that transfusion as early as possible is associated with a reduction in mortality in the context of major trauma.
The aim of the study is to measure the number of patients being cared for by a medical team for major trauma who could benefit from a transfusion labile blood products and thus provide a scientific argument in favour of supplying labile blood products to pre-hospital.
- Conditions
- Trauma Injury
- Being tested
- Data Collection
- Keywords
- Major trauma, Mobile Intensive Care Unit (MCIU), Out of hospital emergency care, Blood transfusion
- Medical subject headings
- Accidental Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data CollectionOther
Collection of medical data from MICU intervention file and patient medical files from participating centres
| Study group | Role | What they receive |
|---|---|---|
| Data collection | Collection of medical data from MICU intervention file and patient medical files from participating centres Receives: Other: Data Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of the proportion of patients being cared for a medical team for major trauma who could have benefited from a pre-hospital transfusion
The main analysis criterion will be the presence, during pre-hospital management, of a massive and immediate blood transfusion criterion measured by the ABC (Assessment of Blood Consumption) score between the arrival of the MICU and 10 minutes before arrival at the hospital.
This score is used to predict the need for massive transfusion, defined in particular as the administration of 4 labile blood products within the first hour of hospital care.
This score will be calculated retrospectively on the basis of data collected from the medical record at the time the patient is taken into medical care, and then every 10 minutes during the course of the care until 10 minutes after arrival at hospital.
An ABC score greater than or equal to 2 indicates a probability of massive transfusion greater than 75%. We will consider a score >= 2 as "probably requiring a pre-hospital transfusion".
Measured: At the end of the study, an average of 4 month
Secondary outcomes (4)
Evaluation of the concordance between the number of patients who received a transfusion during their pre-hospital care and the ABC (Assessment of Blood Consumption) score
The concordance will be assessed by the presence of at least one transfusion, whatever the volume between the work-up and arrival at hospital.
Measured: At the end of the study, an average of 4 month
Assessment of patient mortality on arrival at the resuscitation/recovery centre
Mortality will be assessed by the number of patients alive on arrival of the MICU and dead on arrival at hospital.
Measured: At the end of the study, an average of 4 month
Assessment of patients care time
Care time will be determined by the time between the arrival of the medical team and arrival at the hospital.
Measured: At the end of the study, an average of 4 month
Assessment of the number of patients who could have benefited of a REBOA (Resuscitative Endovascular Balloon Occlusion of the Aorta)
This number will be assessed as follow : number of patients potentially eligible for placement of a REBOA in terms of the presence of abdominal or pelvic bleeding on ultrasound, a PAS > 90 mmHg despite 3 mg/h NAD (noradrenaline) and the absence of thoracic trauma or Supra Aortic Trunks (SATs).
Measured: At the end of the study, an average of 4 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study startApr 2025 (estimated)
- Primary completionMay 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Trauma InjuryStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hôpital NOVO
- Sponsor type
- University, hospital or other
- Collaborators
- Direction Centrale du Service de Santé des Armées
- Responsible party
- Sponsor
- Investigators
- Dr Dorian WOLFF, Principal investigator, Hôpital NOVO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06494293
- Sponsor's protocol ID
- CHRD1024
- Acronym
- TRAP
- Status last verified
- Dec 2024
- First submitted
- 2 Jul 2024
- Last updated
- 31 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bichot A, Pasquier P, Martinaud C, Corcostegui SP, Boutot F, Cazes N, Boutillier du Retail C, Travers S, Galant J. Use of prehospital transfusion by French emergency medical services: A national survey. Transfusion. 2023 May;63 Suppl 3:S241-S248. doi: 10.1111/trf.17374. Epub 2023 Apr 20.
PubMed 37071770Vitalis V, Carfantan C, Montcriol A, Peyrefitte S, Luft A, Pouget T, Sailliol A, Ausset S, Meaudre E, Bordes J. Early transfusion on battlefield before admission to role 2: A preliminary observational study during "Barkhane" operation in Sahel. Injury. 2018 May;49(5):903-910. doi: 10.1016/j.injury.2017.11.029. Epub 2017 Nov 23.
PubMed 29248187Sperry JL, Guyette FX, Brown JB, Yazer MH, Triulzi DJ, Early-Young BJ, Adams PW, Daley BJ, Miller RS, Harbrecht BG, Claridge JA, Phelan HA, Witham WR, Putnam AT, Duane TM, Alarcon LH, Callaway CW, Zuckerbraun BS, Neal MD, Rosengart MR, Forsythe RM, Billiar TR, Yealy DM, Peitzman AB, Zenati MS; PAMPer Study Group. Prehospital Plasma during Air Medical Transport in Trauma Patients at Risk for Hemorrhagic Shock. N Engl J Med. 2018 Jul 26;379(4):315-326. doi: 10.1056/NEJMoa1802345.
PubMed 30044935Eastridge BJ, Mabry RL, Seguin P, Cantrell J, Tops T, Uribe P, Mallett O, Zubko T, Oetjen-Gerdes L, Rasmussen TE, Butler FK, Kotwal RS, Holcomb JB, Wade C, Champion H, Lawnick M, Moores L, Blackbourne LH. Death on the battlefield (2001-2011): implications for the future of combat casualty care. J Trauma Acute Care Surg. 2012 Dec;73(6 Suppl 5):S431-7. doi: 10.1097/TA.0b013e3182755dcc.
PubMed 23192066Fox EE, Holcomb JB, Wade CE, Bulger EM, Tilley BC; PROPPR Study Group. Earlier Endpoints are Required for Hemorrhagic Shock Trials Among Severely Injured Patients. Shock. 2017 May;47(5):567-573. doi: 10.1097/SHK.0000000000000788.
PubMed 28207628
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Many Patients Suffering Major Trauma Would be Eligible for a Pre-hospital Transfusion: A Multicentre Retrospective Study.
- ClinicalTrials.gov ID
- NCT06494293
- Acronym / sponsor ID
- TRAP / CHRD1024
- Conditions
- Trauma Injury
- Keywords
- Major trauma, Mobile Intensive Care Unit (MCIU), Out of hospital emergency care, Blood transfusion
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hôpital NOVOUniversity, hospital or other
- Collaborators
- Direction Centrale du Service de Santé des Armées
- Study start
- Apr 2025 (estimated)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 10 Jul 2024 (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.
The aim of the study is to measure the number of patients being cared for by a medical team for major trauma who could benefit from a transfusion labile blood products and thus provide a scientific argument in favour of supplying labile blood products to pre-hospital
Detailed description
In France, pre-hospital resuscitation of major trauma patients does not use labile blood products, except in exceptional circumstances. The physician staffed Mobile Intensive Care Unit (MICU) are not equipped with this type of product. The first cause of death compatible with survival in the event of pre-hospital treatment identified in major trauma in war medicine is exsanguination. Mortality in haemorrhagic shock occurs rapidly and appears to be significantly reduced if transfusions are performed early. Early transfusion has proved its worth in the military context, leading the armed forces health service to recommend transfusion as a first-line treatment as quickly as possible, from the moment the patient is taken into care on the battlefield. More recently, in the North American civilian pre-hospital setting, the PAMPer study included 501 patients, 230 of whom were transfused with fresh frozen plasma (FFP - 2 units). The authors reported a significant reduction in mortality at D+30 in the FFP group (23.2% vs 33%; p=0.03). It therefore seems that transfusion as early as possible is associated with a reduction in mortality in the context of major trauma.
The aim of the study is to measure the number of patients being cared for by a medical team for major trauma who could benefit from a transfusion labile blood products and thus provide a scientific argument in favour of supplying labile blood products to pre-hospital.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Data collection | – | Other: Data CollectionCollection of medical data from MICU intervention file and patient medical files from participating centres |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients being cared for by a medical team for major trauma requiring transport to an emergency/recovery unit or declared dead during care between the 1st January 2023 and the 31th December 2023.
Key inclusion criteria (4 listed)
- Patients over 18
- Taken care of by a MICU team from participating centres
- Victims of major trauma requiring transport to an emergency/recovery unit or declared dead during care
- Informed and did not object to the collection of his data for research purposes during his lifetime
Key exclusion criteria (5 listed)
- Traumatological reason for departure not confirmed in the emergency medical services report
- Patient care of by the MICU for secondary transport (transport from one hospital to another)
- Patient died without resuscitation by a professional
- Patient with manifest isolated closed head injury
- Patient deprived of civil rights
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data CollectionCollection of medical data from MICU intervention file and patient medical files from participating centres | Other | Data collection |
Primary outcome
Measurement of the proportion of patients being cared for a medical team for major trauma who could have benefited from a pre-hospital transfusion
Time frame: At the end of the study, an average of 4 month
The main analysis criterion will be the presence, during pre-hospital management, of a massive and immediate blood transfusion criterion measured by the ABC (Assessment of Blood Consumption) score between the arrival of the MICU and 10 minutes before arrival at the hospital. This score is used to predict the need for massive transfusion, defined in particular as the administration of 4 labile blood products within the first hour of hospital care. This score will be calculated retrospectively on the basis of data collected from the medical record at the time the patient is taken into medical care, and then every 10 minutes during the course of the care until 10 minutes after arrival at hospital. An ABC score greater than or equal to 2 indicates a probability of massive transfusion greater than 75%. We will consider a score >= 2 as "probably requiring a pre-hospital transfusion".
4 secondary outcomes
Evaluation of the concordance between the number of patients who received a transfusion during their pre-hospital care and the ABC (Assessment of Blood Consumption) score
Time frame: At the end of the study, an average of 4 month
Assessment of patient mortality on arrival at the resuscitation/recovery centre
Time frame: At the end of the study, an average of 4 month
Assessment of patients care time
Time frame: At the end of the study, an average of 4 month
Assessment of the number of patients who could have benefited of a REBOA (Resuscitative Endovascular Balloon Occlusion of the Aorta)
Time frame: At the end of the study, an average of 4 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2024.
- Background: PubMed 37071770Bichot A, Pasquier P, Martinaud C, Corcostegui SP, Boutot F, Cazes N, Boutillier du Retail C, Travers S, Galant J. Use of prehospital transfusion by French emergency medical services: A national survey. Transfusion. 2023 May;63 Suppl 3:S241-S248. doi: 10.1111/trf.17374. Epub 2023 Apr 20.
- Background: PubMed 29248187Vitalis V, Carfantan C, Montcriol A, Peyrefitte S, Luft A, Pouget T, Sailliol A, Ausset S, Meaudre E, Bordes J. Early transfusion on battlefield before admission to role 2: A preliminary observational study during "Barkhane" operation in Sahel. Injury. 2018 May;49(5):903-910. doi: 10.1016/j.injury.2017.11.029. Epub 2017 Nov 23.
- Background: PubMed 30044935Sperry JL, Guyette FX, Brown JB, Yazer MH, Triulzi DJ, Early-Young BJ, Adams PW, Daley BJ, Miller RS, Harbrecht BG, Claridge JA, Phelan HA, Witham WR, Putnam AT, Duane TM, Alarcon LH, Callaway CW, Zuckerbraun BS, Neal MD, Rosengart MR, Forsythe RM, Billiar TR, Yealy DM, Peitzman AB, Zenati MS; PAMPer Study Group. Prehospital Plasma during Air Medical Transport in Trauma Patients at Risk for Hemorrhagic Shock. N Engl J Med. 2018 Jul 26;379(4):315-326. doi: 10.1056/NEJMoa1802345.
- Background: PubMed 23192066Eastridge BJ, Mabry RL, Seguin P, Cantrell J, Tops T, Uribe P, Mallett O, Zubko T, Oetjen-Gerdes L, Rasmussen TE, Butler FK, Kotwal RS, Holcomb JB, Wade C, Champion H, Lawnick M, Moores L, Blackbourne LH. Death on the battlefield (2001-2011): implications for the future of combat casualty care. J Trauma Acute Care Surg. 2012 Dec;73(6 Suppl 5):S431-7. doi: 10.1097/TA.0b013e3182755dcc.
- Background: PubMed 28207628Fox EE, Holcomb JB, Wade CE, Bulger EM, Tilley BC; PROPPR Study Group. Earlier Endpoints are Required for Hemorrhagic Shock Trials Among Severely Injured Patients. Shock. 2017 May;47(5):567-573. doi: 10.1097/SHK.0000000000000788.
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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.
Dr Dorian WOLFF principal investigator
Hôpital NOVO
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trauma Injury, run by Hôpital NOVO at 4 sites in France.
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 4 inclusion and 5 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: opening soon, as of the sponsor's last update on 31 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maryline DELATTRE (+33130754131, maryline.delattre@ght-novo.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of the proportion of patients being cared for a medical team for major trauma who could have benefited from a pre-hospital transfusion (time frame: At the end of the study, an average of 4 month). 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 NCT06494293, which also lists 5 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 31 Dec 2024.