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Clinical Trials/NCT06494293
NCT06494293
Not yet recruiting
Not Applicable

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

Hôpital NOVO4 sites in 1 country200 target enrollmentApril 2025
ConditionsTrauma Injury

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Trauma Injury
Sponsor
Hôpital NOVO
Enrollment
200
Locations
4
Primary Endpoint
Measurement of the proportion of patients being cared for a medical team for major trauma who could have benefited from a pre-hospital transfusion
Status
Not yet recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2025
End Date
May 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Hôpital NOVO
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

  • 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)
  • 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)

Study Sites (4)

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