An interventional study of Viscoelastic Tests (ROTEM) in Trauma Coagulopathy, sponsored by Hospices Civils de Lyon. Not yet recruiting at 7 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-11.
Sponsored by Hospices Civils de Lyon · Not applicable, Interventional, and Diagnostic
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 :
361 studies on the registry are indexed under Hemostatic Disorders; 65 are open to participants now.
This study's planned enrollment of 316 is above the median of 60 across 171 interventional studies indexed under Hemostatic Disorders.
Browse Hemostatic Disorders studies →Hospices Civils de Lyon is the lead sponsor of 1,866 studies on the registry; 448 are open to participants now.
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One of the following criteria:
Severe trauma in shock (shock index > 0.9 or SBP \< 90 mmHg) or with anemia ( \< 11 g.dL-1) and at least 1 of the following criteria:
Severe bone injury :
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
In this arm, patients will have a detection and a correction of the TIC based on conventional coagulation assays. The threshold used to initiate a correction, in case of ongoing bleeding, will be set at fibrinogen concentration ≤ 1.5 gr/L, PTratio \>1.5 or platelets \< 50 G.L-1 (\< 100 G.L-1 in case of severe brain injury).
The detection and correction of TIC will be based on viscoelastic assay using values of clotting time (CT EXTEM), clot amplitude at 5 minutes (A5 FIBTEM and A5 EXTEM) and maximum lysis (ML). The algorithm for the study has been recently published and is based on thresholds for EXTEM (CT, A5 and ML), FIBTEM (A5). The algorithmic correction by fibrinogen concentrates and FFP is initiated using different cutoffs and parameters than in control arm, but the quantity of fibrinogen concentrates and FFP transfused will be similar in both arms.
Device: Viscoelastic Tests (ROTEM)
Viscoelastic Tests (2-6 tests for the study over the first 24 hours)
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
Start is estimated for Oct 2025; primary completion for Jun 2027, 20 months later.
Of 31 non-industry interventional studies with no phase under Hemostatic Disorders, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 40. This study's planned 20 months is below that.
Counting every sponsor, half of 33 studies reached it within 22 months; a quarter within 13 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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