How Many Patients Suffering Major Trauma Would be Eligible for a Pre-hospital Transfusion

NCT06494293 | Not Yet Recruiting

• 1 other identifier: CHRD1024
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 4

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

Conditions

Trauma Injury

Keywords

Major trauma; Mobile Intensive Care Unit (MCIU); Out of hospital emergency care; Blood transfusion

Outcome Measures

Primary Outcomes (1)

• 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".

  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

  At the end of the study, an average of 4 month

• Assessment of patient mortality on arrival at the resuscitation/recovery centre

  At the end of the study, an average of 4 month

• Assessment of patients care time

  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)

  At the end of the study, an average of 4 month

Study Arms (1)

Data collection

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

Other: Data Collection

Interventions

Data Collection OTHER

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

Data collection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hôpital NOVO: lead
• Direction Centrale du Service de Santé des Armées: collaborator

Study Sites (4)

Resuscitation Services (SMUR) Ballanger - Centre Hospitalier Intercommunal Robert Ballanger

Aulnay-sous-Bois, 93600, France

Location

Resuscitation Services (SAMU/SMUR) - Hôpital NOVO -Beaumont/Oise Site

Beaumont-sur-Oise, 95260, France

Location

Resuscitation Services (SAMU/SMUR) - Hôpital NOVO -Pontoise Site

Pontoise, 95300, France

Location

Resuscitation Services (SMUR) Delafontaine - Centre Hospitalier de Saint-Denis

Saint-Denis, 93000, France

Location

Related Publications (5)

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 30044935 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Accidental Injuries

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Dr Dorian WOLFF

  Hôpital NOVO

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maryline DELATTRE

CONTACT

+33130754131; maryline.delattre@ght-novo.fr

Véronique DA COSTA

CONTACT

+33130755069; veronique.dacosta@ght-novo.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2024
• First Posted: July 10, 2024
• Study Start: April 1, 2025
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: December 31, 2024

Record last verified: 2024-12

Locations

FR (4)