Fibrinogen concentrate (FCH)

Fibrinogen concentrate is a single-factor treatment purified from pools of human plasma and processed further into a powder that allows for easy storage and reconstitution at administration. It is approved for the treatment and prophylaxis of congenital fibrinogen deficiencies such as afibrinogenaemia and hypofibrinogenaemia in many countries including the UK, USA, Canada, Australia and many other European countries (Costa-Filho et al., 2016). It is also approved in Brazil, Uruguay, Taiwan and some European countries such as Germany and Austria as the standard treatment for acquired fibrinogen deficiency experienced during trauma, surgery and postpartum haemorrhage (PPH) (Costa-Filho et al., 2016).

Human fibrinogen concentrate (FCH) is obtained through Cohn fractionation of pooled human plasma. The resulting fraction has high purity and allows for accurate dosing since a defined dose is filled per vial.  Reconstitution with sterile water to the desired final concentration for infusion is fast and allows for lower infusion volumes compared to FFP and cryoprecipitate. This latter characteristic reduces the risk of complications related to high transfusion volumes. An additional routine step in the manufacture of fibrinogen concentrate is viral inactivation using techniques such as heat treatment, pasteurisation, nanofiltration, treatment with solvent detergents or a combination of these techniques. This ensures that the risk of viral contamination during treatment remains minimal. The half-life of fibrinogen concentrate was determined as approximately 77 hours in patients of congenital fibrinogen deficiency (Idris et al 2014). A requirement for repeated doses therefore indicates high levels of fibrinogen consumption or limited production. 

There has been recent interest in better understanding the usefulness for fibrinogen concentrate, both for the prevention and treatment of severe bleeding episodes. Also, more comprehensive studies to compare fibrinogen concentrate against the standard cryoprecipitate treatment are underway.

FCH for treatment of congenital deficiency

FCH is the approved standard treatment for acute bleeds and as a prophylactic treatment for congenital fibrinogen deficiencies in the UK, USA, Canada, Australia and many European countries (Costa-Filho et al., 2016). This is because FCH is proven to be safe due to viral inactivation and due to the lower volumes required for infusion (Casini et al., 2016). FCH has been shown to be effective and well tolerated for patients of afibrinogenaemia, hypofibrinogenaemia and dysfibrinogenaemia (Kreuz et al., 2005; Manco-Johnson et al., 2009; Peyvandi, 2009; Casini et al., 2016). FCH has also been shown to improve outcome when used as a prophylactic treatment prior to surgery for congenital fibrinogen deficiency (Bornikova et al., 2011). This benefit needs to be balanced with the risk of thrombolytic complications and supplementation and is therefore restricted to scenarios where bleeding is expected.

FCH for treatment of acquired fibrinogen deficiency

Fibrinogen concentrate is approved for acquired fibrinogen deficiency in Brazil, Uruguay, Taiwan and some European countries such as Germany and Austria (Costa-Filho et al., 2016). Various studies indicate that fibrinogen concentrate may be useful for treating patients with acquired fibrinogen deficiencies experienced during cardiac and other surgeries, postpartum haemorrhage (PPH), trauma, as well as during liver transplantation and more specifically, for dilutional and consumptive coagulopathies.

Discover more in the next section on FCH in cardiac patients

 

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