Traumatic coagulopathy is a complex, multifactorial event that occurs in 20-30% of patients on admission. It increases mortality, and its treatment is one of the main priorities in the early management of severely injured patients. Diagnosis of coagulopathy has traditionally been based on conventional coagulation tests (CCTs), which provide an assessment of patients' coagulation in over 60 minutes. Over the past fifteen years, viscoelastic tests (VETs) have been proposed, providing a more rapid result (≤ 10 min) and can guide the administration of labile blood products (LBP). Various studies, mainly retrospective, have shown that the use of VETs is associated with a significant reduction in the use of LBP and the incidence of massive transfusions (MT). For example, it has been showed that the use of VETs was accompanied by a reduction in the administration of LBP and more particularly of RBC (Red blood cell concentrate) (4.8 units vs. 1.9 units). The investigators obtained the same result on a larger number of patients, with a further reduction in the administration of other LBP and in the incidence of MT (33% vs. 8%, p\<0.01). However, the main limitation of these 2 studies is that the results may not have been due solely to the use of ROTEM, but rather to a care package combining the use of ROTEM with the administration of tranexamic acid and the implementation of Damage Control Surgery techniques. To avoid this methodological criticism, we recently compared 2 contemporary French cohorts (2012-2019), in which patients had similar management of traumatic injuries, with the exception of the type of coagulation tests: CCT vs. VET. The use of VET s was associated with an increase in the number of patients alive at 24h without MT (76% vs. 55%, p\<0.001), but also with a sharp reduction in the administration of all LBPs. This composite criterion associating the occurrence of a MT with survival at 24 hours after hospital admission was the primary endpoint of the randomized iTACTIC study. iTACTICS was published in 2021, and aimed to compare in severely injured patients 2 strategies for the diagnosis and treatment of coagulopathies, based on CCT in one arm and VET in the other. In this work, the use of VET was not associated with an improvement in the proportion of patients alive at 24 hours without MT (64% vs. 67%, OR 1.15, CI95%: 0.8-1.7), nor with any of the other criteria studied. The main limitation of this study is that less than a third of the patients included had a coagulopathy on admission. The probability of receiving LBP was therefore low. In the subgroup of the most severe patients, an improvement in the primary endpoint was observed for patients randomized to the VET group. The small sample size and subgroup analysis, however, limited the significance of this result. All these elements suggest that it is necessary : * to use a composite endpoint rather than a single endpoint (mortality) for the evaluation of VET-based strategies, combining early mortality with the occurrence of a transfusion event. * conduct a randomized trial comparing the use of VETs with that of CCTs in trauma patients with a high probability of coagulopathy on admission to hospital.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
316
Viscoelastic Tests (2-6 tests for the study over the first 24 hours)
Service d'Anesthésie - Réanimation, CHU Angers
Angers, France
Service d'Anesthésie - Réanimation, Groupe Hospitalier Pellegrin CHU de Bordeaux
Bordeaux, France
Service de Réanimation - CH Annecy Genevois
Epagny METZ Tessy, France
Service d'Anesthésie - Réanimation, Hôpital Michallon- CHU Grenoble
La Tronche, France
Service d'Anesthésie - Réanimation, HCL Edouard Herriot
Lyon, France
Service d'Anesthésie-Réanimation, HCL Lyon Sud
Pierre-Benité, France
Service d'Anesthésie - Réanimation, HIA St Anne Toulon
Toulon, France
The survival without massive transfusion 24 hours after admission in the VET arm as compared to the CCT arm.
24 hours after admission in the VET arm as compared to the CCT arm. The survival 24 hours after admission will be combine with the non-occurrence of massive transfusion (i.e., at least 10 units of RBC received at 24h). This comparison will be first carried out in a crude manner, and then considering the stratification factor, i.e., a Glasgow Coma Scale \< 9 (severe traumatic brain injury) and administration of plasma (FFP or lyophilized plasma).
Time frame: 24hours after admission
Number and proportion of patient receiving labile blood products, at 4, 6 and 24 hours after hospital admission.
Time frame: 4, 6 and 24 hours after hospital admission
Number and proportion of patients receiving fibrinogen concentrates as well as the quantity administered (in grams), at 6 and 24 hours after hospital admission
Time frame: 6 and 24 hours after hospital admission
Number and proportion of patients who received massive transfusion, time critical transfusion and Rescue therapy
* A massive transfusion (MT, ≥ 10 RBC at H24) * A time critical transfusion (≥ 6 RBC at H6 following the admission). * Rescue therapy, defined as the emergency administration of blood products because the patient's clinical condition makes it impossible to wait for the results of biological tests (CCT or VTE).
Time frame: 24 hours
Number of RBCs received from admission to ICU discharge (or at 28 days maximum after randomization (Day 28)).
Time frame: At discharge or at 28 days maximum after randomization (Day 28))
Number and proportion of patients with a "Sepsis-related Organ Failure Assessment" (SOFA) score > 5, after randomization, at H24, Day 2, Day 3, Day 4.
Time frame: 4 days
Ventilator-free days, vasopressor days, renal replacement therapy days
Ventilator-free days (Calculated by the subtracting the number of days spent on mechanical ventilation from 28), vasopressor days (calculated as the total number of days spent on inotropic drugs, for example noradrenaline), renal replacement therapy days (calculated as the total number of days spent on hemofiltration or hemodialysis).
Time frame: 28 days
Total volume (mL) of fluids received at 24-hours including blood products and fluid resuscitation (crystalloids and colloids).
Time frame: H24
Number and proportion of patients who died at H6, H24 and Day 28
* For any reason (crude mortality) * By ISS score value (9-15=moderate trauma, 16-24 = severe trauma, ≥ 25 = very severe trauma) and stratified on the occurrence of brain-injury (defined by head AIS \> 3), according to shock define by a lactate more than 3.9 mmol.l-1 * By attributable cause of death, including trauma brain injuries, bleeding, anoxia, sepsis, other The time median between randomization and the occurrence of death will be measured and compared between trial arms.
Time frame: 28 days
Length of stay in the intensive care unit up to Day 28.
Time frame: 28 days
Timing and the number of hemorrhage control procedures (surgery, interventional radiology) in the first 6-hours following admission.
Time frame: 6 hours
Number and proportion of patients with grade 3 and 4 adverse events related to the management strategy between randomization and Day 28
* Ventilator-associated pneumonia * Acute Respiratory Distress Syndrome (ARDS) * Acute renal failure as defined by KDIGO (Kidney Disease / Improving Global Outcome 2012) * Septic shock defined * Any thromboembolic event; pulmonary embolism, deep vein thrombosis, gastrointestinal ischemia, non-traumatic limb ischemia, myocardial infarction, ischemic stroke.
Time frame: 28 days
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