How Many Patients Suffering Major Trauma Would be Eligible for a Pre-hospital Transfusion
ConditionTrauma Injury
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHôpital NOVO
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial 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.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Data Collection
Other interventionCollection of medical data from MICU intervention file and patient medical files from participating centres
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: Data collection1 intervention
Trial outcomes
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
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".
Time frame
At the end of the study, an average of 4 monthSecondary 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
The concordance will be assessed by the presence of at least one transfusion, whatever the volume between the work-up and arrival at hospital.
Time frame
At the end of the study, an average of 4 month2
Assessment of patient mortality on arrival at the resuscitation/recovery centre
Mortality will be assessed by the number of patients alive on arrival of the MICU and dead on arrival at hospital.
Time frame
At the end of the study, an average of 4 month3
Assessment of patients care time
Care time will be determined by the time between the arrival of the medical team and arrival at the hospital.
Time frame
At the end of the study, an average of 4 month4
Assessment of the number of patients who could have benefited of a REBOA (Resuscitative Endovascular Balloon Occlusion of the Aorta)
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).
Time frame
At the end of the study, an average of 4 monthSponsors and contacts
Click on the lead sponsor to view all of their trials.
Hôpital NOVO
Lead sponsor
Direction Centrale du Service de Santé des Armées
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: