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

Abstract

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 fi xed-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 coagulo pathy, suggesting a need for the early identifi cation and treatment of coagulopathy that ROTEM® enables. Altogether, these factors provided a rationale for imple menting 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 (fi brinogen concentrate and prothrombin complex concentrate) correct coagulopathy eff ectively and rapidly, indicated by normalisation of ROTEM® parameters among bleeding trauma patients (Table 1). European guidelines for managing trauma raised the target fi brinogen concentra tion to 1.5 to 2 g/l [4], which we fi nd diffi cult to reach without using fi brinogen concentrate. Without a com parator group, our data are insuffi cient 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 hyperfi brinolysis. As reported elsewhere, we found that fulminant hyperfi brinolysis is associated with high mortality. Fulminant hyperfi brinolysis 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 benefi t from immediate, proactive administration of 1 g tranexamic acid followed by 2 to 4 g fi brinogen concentrate, with further doses as soon as ROTEM® results are available. 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 defi ciency. 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 concen trates in trauma, creating a degree of uncertainty with both of these options. Nevertheless, we consider the rationale to be stronger for ROTEM®-guided, concentratebased therapy.