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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06494293
Acronym
TRAP
Enrollment
200
Registered
2024-07-10
Start date
2025-04-30
Completion date
2025-05-31
Last updated
2024-12-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Trauma Injury

Keywords

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

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.

Interventions

OTHERData Collection

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

Sponsors

Direction Centrale du Service de Santé des Armées
CollaboratorOTHER
Hôpital NOVO
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Measurement of the proportion of patients being cared for a medical team for major trauma who could have benefited from a pre-hospital transfusionAt the end of the study, an average of 4 monthThe 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

MeasureTime frameDescription
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) scoreAt the end of the study, an average of 4 monthThe 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 centreAt the end of the study, an average of 4 monthMortality will be assessed by the number of patients alive on arrival of the MICU and dead on arrival at hospital.
Assessment of patients care timeAt the end of the study, an average of 4 monthCare 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 monthThis 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).

Countries

France

Contacts

Primary ContactMaryline DELATTRE
maryline.delattre@ght-novo.fr+33130754131
Backup ContactVéronique DA COSTA
veronique.dacosta@ght-novo.fr+33130755069

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026