Trauma is the leading cause of death worldwide in individual’s aged 18-39 with data from the WHO suggesting that worldwide almost 6 million deaths every year are directly attributable to trauma. Despite advances in trauma management, a significant proportion of these deaths are still due to haemorrhage. Death can occur early as a result of uncontrollable haemorrhage; in patients where surgical haemorrhage control is achieved subsequent morbidity and mortality can be attributed to effects of massive haemorrhage and large volume blood product transfusion.
Trauma Induced Coagulopathy (TIC) is a complex coagulopathy associated with severe trauma. Hypofibrinogenaemia plays an important role in TIC. Fibrinogen is an important blood clotting protein that helps form stable blood clots to stop bleeding. Fibrinogen levels fall very quickly in severe traumatic haemorrhage and it is postulated that early replacement of fibrinogen may improve outcomes. The majority of trauma centres in Australia utilise cryoprecipitate for additional fibrinogen supplementation as part of a Massive Transfusion protocol. There is an increasing use of early Fibrinogen Concentrate in severe bleeding but this is not supported by high level evidence.
There are currently no previous published studies comparing a targeted dose of Fibrinogen Concentrate and Cryoprecipitate in bleeding trauma patients. This pilot multi-centre randomised controlled trial will compare Fibrinogen Concentrate to Cryoprecipitate for fibrinogen replacement in severely injured trauma patients. The FEISTY study will be performed at 4 major trauma centres in Queensland, Australia.