Annually over 7000 Australians are treated for severe trauma. Haemorrhage secondary to severe
trauma is a major cause of potentially preventable death and poor outcomes in Australian
adults. Severe trauma may trigger changes in blood clotting mechanisms and factor levels
leading to inhibition of clot formation and reduced clot strength. This results in the
inability of the severely injured trauma patient to form adequate clots to help stop
bleeding. There is good evidence to suggest the loss of clotting factors during haemorrhage
is associated with worse outcomes and it is thought the early replacement of these factors
may reduce bleeding and improve patient outcomes. Fibrinogen is a key clotting factor that
helps bind clots together and early fibrinogen replacement may improve outcomes.
Currently fibrinogen is replaced using cryoprecipitate, a blood product made from blood
donated by healthy donors which is a precious resource. It can take a significant amount of
time to administer as it is frozen and stored in the blood bank. Timely administration of
cryoprecipitate is difficult as it requires thawing prior to transfusion. The large doses of
cryoprecipitate used in traumatic haemorrhage can put strain on local blood banks in
supplying requested units in a timely manner. Additionally, the widely dispersed population
of Australia introduces logistic challenges to the maintenance of adequate cryoprecipitate
stocks to individual hospital blood banks, especially in remote regions. However,
cryoprecipitate contains a number of other coagulation factors (not just fibrinogen) that may
be instrumental in clot formation and resistance to fibrinolysis.
Fibrinogen concentrate is an alternative product used to assist in blood clotting. It is a
dry powder form of fibrinogen and can be reconstituted at the bedside and given quickly. The
use of a fibrinogen factor concentrate with a long shelf life that is easy to use has
significant implications for both large urban metropolitan areas and remote isolated
communities.
The timing and mode of fibrinogen replacement in traumatic haemorrhage has implications for
patient outcomes, blood product availability, costs and the national blood supply. Despite
the importance of fibrinogen replacement in traumatic haemorrhage, there have been no
clinical trials powered for clinical outcomes directly comparing fibrinogen concentrate and
cryoprecipitate. FEISTY II will evaluate the efficacy, safety and cost-effectiveness of
Fibrinogen Concentrate vs Cryoprecipitate in trauma patients with major haemorrhage.
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 standard care with cryoprecipitate
Phase:
Phase 3
Details
Lead Sponsor:
Australian and New Zealand Intensive Care Research Centre
Collaborators:
Australasian College for Emergency Medicine Australasian Trauma Society Australian and New Zealand Intensive Care Society Clinical Trials Group Australian Red Cross Lifeblood Blood Synergy Program