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

Not yet recruiting

• Conditions: Trauma Injury
• Interventions: Other: Data Collection

• Registration Number: NCT06494293
• Lead Sponsor: Hôpital NOVO

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.

Study Timeline

• Study First Submitted: 2024-07-02
• Study First Submitted QC: 2024-07-09
• Study First Posted: 2024-07-10
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-30
• Last Update Posted: 2024-12-31
• Study Start: 2025-04
• Primary Completion: 2025-05
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Data collection	Data Collection	Collection of medical data from MICU intervention file and patient medical files from participating centres

Primary Outcome Measures

Name	Time	Method
Measurement of the proportion of patients being cared for a medical team for major trauma who could have benefited from a pre-hospital transfusion	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 Outcome Measures

Name	Time	Method
Assessment of patients care time	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.
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	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).
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	The concordance will be assessed by the presence of at least one transfusion, whatever the volume between the work-up and arrival at hospital.
Assessment of patient mortality on arrival at the resuscitation/recovery centre	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.

Trial Locations

Locations (4)

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

Resuscitation Services (SAMU/SMUR) - Hôpital NOVO -Beaumont/Oise Site; 🇫🇷 Beaumont-sur-Oise, France

Resuscitation Services (SAMU/SMUR) - Hôpital NOVO -Pontoise Site; 🇫🇷 Pontoise, France

Resuscitation Services (SMUR) Delafontaine - Centre Hospitalier de Saint-Denis; 🇫🇷 Saint-Denis, France