Haemocomplettan® P (fibrinogen concentrate) and Fibrogammin® P (factor XIII concentrate) have been licensed in Austria since 1994 and 2000, respectively, despite a lack of evidence proving their efficacy and safety. In addition, the consumption particularly of Haemocomplettan® P has been increasing steadily within Austrian hospitals since 2001. In Austria fibrinogen concentrate is indicated for the treatment of both congenital hypofibrinogenemia which occurs rarely, and acquired hypofibrinogenemia which occurs much more frequently.
Acquired hypofibrinogenemia occurs frequently due to impaired synthesis, increased consumption, or increased loss of fibrinogen due to a number of underlying clinical conditions. The conventional method of measuring the plasma fibrinogen level is the Clauss assay. Nevertheless, ROTEM® rotational thrombelastometry is being increasingly employed in estimating the fibrinogen level and guiding transfusion of blood products. Its advantages are that it is a point-of-care device and that it provides results more quickly than the Clauss assay. However, the ROTEM® method appears to suggest substitution of fibrinogen more often than would be required, possibly leading to an increased rate of adverse events, such as thrombembolic complications.
The evidence concerning Haemocomplettan® P is of poor quality. Thresholds and dosages for the substitution of fibrinogen concentrate remain unclear. Moreover, the assessment of heterogeneous, highly selected, and severely ill patient populations compromise the generalisability of results. There is lack of evidence investigating the efficacy and safety of Fibrogammin® P because only one trial could be found regarding this drug. In addition, no evidence at all could be identified for the combined administration of Haemocomplettan® P and Fibrogammin® P.
There is an urgent need for evidence-based, national transfusion guidelines in Austria which are lacking at present. Existing guidelines, namely guidelines published by the Task Force for Coagulation of the Austrian Society of Anesthesiology, Resuscitation, and Intensive Care Medicine as well as local guidelines in one Austrian University Hospital, are neither evidence-based nor in accordance with recent guidelines from Canada, Great Britain, or Germany.