Clinical trial NCT06494293: How Many Patients Suffering Major Trauma Would be Eligible for a Pre-hospital Transfusion
Official title: How Many Patients Suffering Major Trauma Would be Eligible for a Pre-hospital Transfusion: A Multicentre Retrospective Study.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Trauma Injury
Keywords: Major trauma
Mobile Intensive Care Unit (MCIU)
Out of hospital emergency care
Blood transfusion
Lead sponsor: Hôpital NOVO
Sponsor class: OTHER
Collaborators: name: Direction Centrale du Service de Santé des Armées
First posted: 2024-07-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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

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.

Eligibility criteria: Inclusion Criteria :

* 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

Exclusion Criteria :

* 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

Primary outcomes:
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
timeFrame: At the end of the study, an average of 4 month
Secondary outcomes:
measure: 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
timeFrame: At the end of the study, an average of 4 month
measure: Assessment of patient mortality on arrival at the resuscitation/recovery centre
timeFrame: At the end of the study, an average of 4 month
measure: Assessment of patients care time
timeFrame: At the end of the study, an average of 4 month
measure: Assessment of the number of patients who could have benefited of a REBOA (Resuscitative Endovascular Balloon Occlusion of the Aorta)
timeFrame: At the end of the study, an average of 4 month
Other outcomes:
Locations:
city: Aulnay-sous-Bois
country: France
facility: Resuscitation Services (SMUR) Ballanger - Centre Hospitalier Intercommunal Robert Ballanger
city: Beaumont-sur-Oise
country: France
facility: Resuscitation Services (SAMU/SMUR) - Hôpital NOVO -Beaumont/Oise Site
city: Pontoise
country: France
facility: Resuscitation Services (SAMU/SMUR) - Hôpital NOVO -Pontoise Site
city: Saint-Denis
country: France
facility: Resuscitation Services (SMUR) Delafontaine - Centre Hospitalier de Saint-Denis
Study officials:
affiliation: Hôpital NOVO
name: Dr Dorian WOLFF
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Vitalis 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.
citation: Sperry 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.
citation: Eastridge 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.
citation: Fox 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.