Clinical Research Directory

Point of Care Fibrinogen Measurement in Trauma Patients in the Emergency Department

Background: Why This Study Matters When someone suffers a severe injury (like from a car crash), they can bleed heavily. One complication doctors often face is something called Trauma-Induced Coagulopathy (TIC). This is a condition where the blood doesn't clot properly, making bleeding worse. The reasons behind TIC are complicated and not fully understood. One important substance involved is fibrinogen, a protein that helps blood clot. Low levels of fibrinogen are often the first sign of TIC and tend to be linked with how bad the injury is. Because of this, doctors have been giving trauma patients extra fibrinogen early on, hoping it will help them survive. However, a recent large study (called CRYOSTAT-2) showed that giving high doses of fibrinogen to all trauma patients didn't actually help reduce deaths. This suggests that not everyone needs it-only patients with very low fibrinogen levels (below 1.5 grams per liter) should get it. The problem is: it currently takes 30 to 45 minutes to get fibrinogen test results. In emergency situations, that's too slow. So doctors have been guessing who needs it, which might not always be the best approach. What This Study Aims to Do This new study wants to see if a faster, bedside test-called a point-of-care (POC) fibrinogen test-can be used in the Emergency Department (ED) during trauma resuscitations. Main Goals: Feasibility: Can the test be done quickly and easily during emergency care? Usefulness: If the fast test had been available, would doctors have made different decisions-like giving or not giving fibrinogen? And would that have changed outcomes for the patients? Study Details Feasibility Study: To see if the test is practical during trauma care. Retrospective Cohort Study: To look back at patients and see if early test results could have changed decisions or outcomes. Who's In the Study? Adults over 16 who arrive at the ED with serious trauma and for whom the hospital's Massive Transfusion Protocol was activated (meaning they had major bleeding). They must have received at least one unit of blood. How the Study Will Work The Test: A small amount of blood (0.15 ml) will be taken from blood that's already being drawn for routine care-so no extra blood draws are needed. The POC test (called qLabs Fib) will be done at the same time as standard lab tests. Important Note: Doctors won't make decisions based on this fast test for now. It's just being tested for feasibility. Nurses will note how long the test takes and if they had any trouble using it. Later, researchers will look back at the data to see: * What the fibrinogen levels were. * Whether the fast results could have helped guide better treatment. * If outcomes like how much blood was given or survival were affected. Why It Matters If the fast test works well, it could lead to * Faster, more accurate treatment in trauma cases. * Less unnecessary use of fibrinogen, saving resources and avoiding possible side effects. * Better outcomes for patients by tailoring treatment to their actual needs.

Implementation of an Empiric Transfusion Bundle for Out of Hospital Patients With Haemorrhagic Shock

The investigators will evaluate the implementation of a treatment bundle (Fibrinogen, Plasma and Tranexamic Acid)

Viscoelastic Tests (VET) Versus Conventional Coagulation Tests (CCT) for Management of Trauma-Induced Coagulopathy

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.

ROTEM in Sepsis Trauma Outcome in Intensive Care

This prospective observational study aims to investigate the ability of advanced ROTEM analysis using Principal Component Analysis (PCA) to detect early signs of disseminated intravascular coagulation (DIC) and trauma-induced coagulopathy (TIC) in hospitalized patients with sepsis or trauma. Standard coagulation tests and ROTEM measurements will be collected and analyzed in relation to clinical outcomes.

Tranexamic Acid in Patients With Traumatic Bleeding Based on Dynamic Monitoring of Thromboelastography

Trauma is an important global public health problem and is the leading cause of death in people under 40 years old. Studies have shown that early prehospital administration of TXA 1 g intravenously followed by a continuous infusion of 1 g tranexamic acid (TXA) over 8 hours ( 1+1 regimen) is effective in reducing mortality in trauma patients, but there is a residual risk of death. This clinical study utilized real-time dynamic monitoring of coagulation fibrinolytic status in trauma patients using thromboelastography (TEG) to assess the need for a second or even multiple administrations of TXA (1+X regimen) in addition to the administration of 1 g of TXA intravenously and to compare the two mortality rates, thus guiding the early and precise use of TXA in trauma patients to potentially reduce mortality in trauma patients while decreasing thromboembolic risk. The present study is an optimization and addition to the TXA 1+1 regimen. Currently, no relevant studies have been reported. This study has important clinical significance for standardizing the early and precise use of TXA in trauma patients and improving the effectiveness and safety of TXA.