ANZICS CTG Endorsed Study


Fibrinogen Early In Severe Trauma studY II

Study Description

A prospective phase III, multi-centre, randomised, controlled, two arm parallel, open label trial evaluating the effect of Fibrinogen Concentrate (FC) compared to standard care, Cryoprecipitate (Cryo) in severely injured bleeding adult trauma patients with hypofibrinogenemia.

Major haemorrhage in the setting of severe trauma is associated with significant morbidity and mortality. Haemorrhage is compounded by Trauma Induced Coagulopathy of which hypofibrinogenaemia plays a significant role. There is good evidence to suggest that hypofibrinogenaemia in trauma is associated with worse outcomes and it is postulated that early replacement may reduce haemorrhage and improve outcomes. The FEISTY pilot trial has demonstrated that a guided fibrinogen replacement strategy utilising FC or Cryo is feasible and it is significantly quicker to administer FC compared to Cryo. The optimal form of fibrinogen replacement (FC or Cryo) in traumatic haemorrhage continues to be debated with limited quality evidence. There are a number of theoretical benefits to FC none of which have been evaluated in a RCT. The size and population distribution of Australia makes the rapid availability of FC an attractive option but its efficacy must be tested in a RCT. FEISTY II Trial will evaluate clinically relevant endpoints of a guided dose of FC vs. Cryo (standard of care) in traumatic haemorrhage.

Management Committee

Zoe McQuilten, James Winearls, Jamie Cooper, Stephane Heretier, Elizabeth Wake, Tony Trapani, Bridget Ady, James Moore, Shaanti Olatunji

Administering Institution

ANZIC -RC, Monash University

Sample Size

850 patients




CTG2021-04, NCT05449834


James Winearls (email)