ROTEM^®-guided coagulation factor concentrate therapy in trauma: 2-year experience in Venice, Italy

Haemostatic therapy for trauma-induced coagulopathy is typically based on administration of allogeneic blood products, although the evidence supporting this approach is poor [1]. Fixed-ratio protocols have been proposed for administering fresh frozen plasma, red blood cells and platelets, but the optimal ratio has not been established and the speed of intervention may be more important [2].

In contrast to fixed-ratio treatment, coagulation factor concentrate therapy guided by point-of-care monitoring allows patients' actual needs to be targeted [3]. Our initial experience with ROTEM^® (Tem International GmbH, Munich, Germany) indicated correlation between the clinical condition and extent of coagulopathy, suggesting a need for the early identification and treatment of coagulopathy that ROTEM^® enables. Altogether, these factors provided a rationale for implementing ROTEM^®-guided therapy for trauma patients in our hospital.

In our experience, this approach is feasible and can replace formula-driven treatment. We found that coagulation factor concentrates (fibrinogen concentrate and prothrombin complex concentrate) correct coagulopathy effectively and rapidly, indicated by normalisation of ROTEM^® parameters among bleeding trauma patients (Table 1). European guidelines for managing trauma raised the target fibrinogen concentration to 1.5 to 2 g/l [4], which we find difficult to reach without using fibrinogen concentrate. Without a comparator group, our data are insufficient to show reduced red blood cell transfusion or improvements in morbidity/mortality. However, we did see a progressive reduction in fresh frozen plasma consumption. Another advantage of using a ROTEM^®-guided approach is the opportunity to detect hyperfibrinolysis. As reported elsewhere, we found that fulminant hyperfibrinolysis is associated with high mortality. Fulminant hyperfibrinolysis may potentially be considered the last gasp of the coagulation system; it may be a marker not only of severe coagulopathy, but also of poor clinical outcome. Our experience also suggests that patients with massive bleeding may benefit from immediate, proactive administration of 1 g tranexamic acid followed by 2 to 4 g fibrinogen concentrate, with further doses as soon as ROTEM^® results are available.

Table 1 Details of bleeding trauma patients receiving ROTEM^®-guided coagulation factor concentrate treatment

Fibrinogen concentrate is currently imported in Italy and we use it according to the manufacturer's label. In some countries the product is licensed only for congenital deficiency. However, it is possible to use life-saving drugs for indications beyond the label, providing the physician is convinced that this use is in the patient's best interest; such practice is regulated by health authorities in several countries. High-quality, randomised controlled trials are lacking for both allogeneics and coagulation factor concentrates in trauma, creating a degree of uncertainty with both of these options. Nevertheless, we consider the rationale to be stronger for ROTEM^®-guided, concentrate-based therapy.