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. Haemorrhage secondary to severe trauma is a major cause of potentially preventable death and poor outcomes. Severe trauma triggers changes in blood clotting leading to a problem with clot formation and clot strength. This results in a decreased ability for the severely injured trauma patient to form adequate clots and stop bleeding. There is good evidence that the loss of clotting factors during haemorrhage is associated with worse outcomes and it is thought that early replacement of these factors may reduce bleeding and improve a patient’s outcome. Fibrinogen is a key clotting factor that helps bind clots together. Early fibrinogen replacement may improve outcomes.
Currently, there are two ways fibrinogen can be replaced; either using cryoprecipitate (Cryo) or fibrinogen concentrate (FC). There are pros and cons for both forms of fibrinogen replacement and their effects have to date not been investigated in an RCT involving trauma patients. The FEISTY II trial is informed by the FEISTY Pilot trial. The FEISTY Pilot trial enrolled 100 bleeding trauma patients and investigated whether it was possible to give FC and Cryo early in trauma resuscitation, and which could be given faster. The trial also investigated the assessment of clot strength and quality using either FC or Cryo. The trial showed the FC could be administered in a shorter timeframe than cryoprecipitate. However, although both Cryo and FC increased the fibrinogen levels of patients, the results suggested that the blood clot may be stronger with Cryo. The size and population distribution of Australia makes the rapid availability of FC an attractive option but its efficacy compared to Cryo must be tested in a RCT.
FEISTY II is a phase III randomised trial which will enrol 850 patients from Australian and New Zealand major trauma centres, with a primary patient outcome of days alive out of hospital at day 90 after injury. Severely injured trauma patients who require blood transfusion and have evidence of low fibrinogen levels will be randomised to receive either FC or Cryo.