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

NCT ID: NCT06494293

Last Updated: 2024-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-04-30

Study Completion Date

2025-05-31

Brief Summary

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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

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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

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Trauma Injury

Keywords

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Data collection

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

Data Collection

Intervention Type OTHER

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

Interventions

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Data Collection

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Direction Centrale du Service de Santé des Armées

OTHER

Sponsor Role collaborator

Hôpital NOVO

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dr Dorian WOLFF

Role: PRINCIPAL_INVESTIGATOR

Hôpital NOVO

Locations

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

Aulnay-sous-Bois, , France

Site Status

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

Beaumont-sur-Oise, , France

Site Status

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

Pontoise, , France

Site Status

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

Saint-Denis, , France

Site Status

Countries

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France

Central Contacts

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Maryline DELATTRE

Role: CONTACT

Phone: +33130754131

Email: [email protected]

Véronique DA COSTA

Role: CONTACT

Phone: +33130755069

Email: [email protected]

Facility Contacts

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Dr Valérie RAPHAEL

Role: primary

Dr Dorian WOLFF

Role: primary

Dr Dorian WOLFF

Role: primary

Dr Brigitte Hennequin

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 37071770 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29248187 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30044935 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23192066 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28207628 (View on PubMed)

Other Identifiers

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CHRD1024

Identifier Type: -

Identifier Source: org_study_id