Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06494293

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

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

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Trauma Injury Accidental Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Resuscitation Services (SMUR) Ballanger - Centre Hospitalier Intercommunal Robert Ballanger, Aulnay-sous-Bois, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Data Collection

Other

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

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

    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".

Secondary outcomes

  1. 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

    The concordance will be assessed by the presence of at least one transfusion, whatever the volume between the work-up and arrival at hospital.

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

    Time frame: At the end of the study, an average of 4 month

    Mortality will be assessed by the number of patients alive on arrival of the MICU and dead on arrival at hospital.

  3. Assessment of patients care time

    Time frame: At the end of the study, an average of 4 month

    Care time will be determined by the time between the arrival of the medical team and arrival at the hospital.

  4. 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

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Maryline DELATTRE

CONTACT

[email protected]

+33130754131

Véronique DA COSTA

CONTACT

[email protected]

+33130755069

Sponsors and collaborators

Lead sponsor

Hôpital NOVO

Other

Collaborators

  • Direction Centrale du Service de Santé des Armées

Registry information

Official study title

How Many Patients Suffering Major Trauma Would be Eligible for a Pre-hospital Transfusion: A Multicentre Retrospective Study.

Acronym: TRAP

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 10, 2024
Registry last updated
Dec 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.