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

December 30, 2024 updated by: Hôpital NOVO

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

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Aulnay-sous-Bois, France, 93600
        • Resuscitation Services (SMUR) Ballanger - Centre Hospitalier Intercommunal Robert Ballanger
        • Contact:
      • Beaumont-sur-Oise, France, 95260
        • Resuscitation Services (SAMU/SMUR) - Hôpital NOVO -Beaumont/Oise Site
        • Contact:
      • Pontoise, France, 95300
        • Resuscitation Services (SAMU/SMUR) - Hôpital NOVO -Pontoise Site
        • Contact:
      • Saint-Denis, France, 93000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Data collection
Collection of medical data from MICU intervention file and patient medical files from participating centres
Other: Data Collection
Collection of medical data from MICU intervention file and patient medical files from participating centres

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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".
At the end of the study, an average of 4 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At the end of the study, an average of 4 month
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.
At the end of the study, an average of 4 month
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.
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)
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).
At the end of the study, an average of 4 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hôpital NOVO

Collaborators

Direction Centrale du Service de Santé des Armées

Investigators

  • Principal Investigator: Dr Dorian WOLFF, Hôpital NOVO

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2025

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

July 2, 2024

First Submitted That Met QC Criteria

July 9, 2024

First Posted (Actual)

July 10, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 30, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHRD1024

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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