For patients who had been affected by severe trauma and critical bleeding, timely treatment is lifesaving. Often a transfusion of blood product is required for the purpose of replenishing blood loss and/or for the treatment of clotting abnormalities that are common in trauma. In Australia, uncontrolled bleeding is directly responsible for about a third of in-hospital trauma deaths.
Fibrinogen is an important blood clotting protein. When patients have significant bleeding their levels of fibrinogen can be very low. There have been indications that early replacement of this protein may help to reduce bleeding. In this study, all eligible patients will receive fibrinogen. They will be randomly selected to receive fibrinogen in one of two forms. One is a concentrated agent (Fibrinogen Concentrate) and the other is transfusion of a blood product that contains fibrinogen (Cryoprecipitate). Each patient’s fibrinogen replacement needs will be assessed using a specific blood test.
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 fibrinogen concentrate or cryoprecipitate.
