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.

Overview

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.

Interventions

• Other Data Collection
  Collection of medical data from MICU intervention file and patient medical files from participating centres

Primary outcome measures

• 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]

Secondary outcome measures (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 [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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

France · 4 centers

• Resuscitation Services (SMUR) Ballanger - Centre Hospitalier Intercommunal Robert Ballange — Aulnay-sous-Bois
• Resuscitation Services (SAMU/SMUR) - Hôpital NOVO -Beaumont/Oise Site — Beaumont-sur-Oise
• Resuscitation Services (SAMU/SMUR) - Hôpital NOVO -Pontoise Site — Pontoise
• Resuscitation Services (SMUR) Delafontaine - Centre Hospitalier de Saint-Denis — Saint-Denis

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. PMID 37071770
• 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. PMID 29248187
• 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 Hemorr PMID 30044935
• 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. PMID 23192066
• 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. PMID 28207628

Identifiers

NCT: NCT06494293 · CHRD1024

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗