Clarifying the role of fibrinogen concentrate in major haemorrhage: a reply

We thank Dr Rohrbacher for his comments regarding the use of fibrinogen concentrate to manage major haemorrhage across specialties [1]. We agree that its use is no longer ‘off-label’ and have corrected this accordingly in Table 1 here and a corrigendum will be issued to accompany the guidelines [2]. However, we would like to highlight that the current indication listed in the Summary of Product Characteristics: “treatment of bleeding episodes and peri-operative prophylaxis in patients with congenital hypo- or afibrinogenaemia with bleeding tendency”, is subject to interpretation.

We agree that there are currently no published superiority clinical effectiveness data for human fibrinogen concentrate (Fibryga^®, Octapharma Ltd, Manchester, UK) over cryoprecipitate. This should be balanced against the putative benefits of fibrinogen concentrate (logistical advantages, storage requirements, preparation times). Previous systematic reviews have shown a paucity of high-quality data [3], but the evidence-base is shifting. Recently, the FIBRES trial showed that fibrinogen concentrate was non-inferior to cryoprecipitate in patients undergoing cardiac surgery [4]. A within-trial health economic evaluation of FIBRES found that fibrinogen concentrate was cost-effective when compared with cryoprecipitate [5]. An ongoing phase-3 randomised trial, FEISTY-2 [6], will allocate 850 patients randomly from Australian and New Zealand major trauma centres to receive either fibrinogen concentrate or cryoprecipitate.