FEISTY – Fibrinogen Early In Severe Trauma study

Is it quicker to administer Fibrinogen concentrate than cryoprecipitate?

Grant ID: EMPJ-357R25-2016

Lay Summary

This clinical trial aims to improve the quality of the resuscitation of patients with traumatic haemorrhage. We are enrolling 100 patients from four major trauma centres in Queensland. Patients admitted with severe traumatic bleeding will be given either Fibrinogen concentrate or cryoprecipitate. Time to administration of these products and effects on blood fibrinogen levels will be measured. We are using innovative technology to identify hypofibrinogenaemia; we will provide data to define the optimal method of replacement and monitoring of the end points of resuscitation; and provide data on the role of fibrinogen concentrate and its use in traumatic haemorrhage. We are also exposing a broad range of ED physicians to potential practice changing research that may be translated to use in other patient groups with critical bleeding.

More than 7000 Australians are treated for severe trauma every year. Major bleeding in the setting of trauma is associated with poor outcomes and increased rates of death. Severe trauma causes a decrease in the factors within the blood that helps clots to form and stop bleeding. This loss of clotting factors is associated with worse outcomes and it is proposed that early replacement of these factors may reduce bleeding and improve outcomes. Fibrinogen is one of the key clotting factors that needs to be replaced in severe traumatic bleeding. Currently fibrinogen is replaced using cryoprecipitate; a blood product obtained from healthy volunteer donors. This is a precious resource that is stored frozen in the blood bank; it can take a long time to administer and place significant strain on blood banks. Fibrinogen concentrate (FC) is an alternative product used to assist in blood clotting. It is stored in powder form, can be reconstituted at the bedside and given quickly. The study will investigate whether it is quicker to administer FC than cryoprecipitate, which will reduce haemorrhage and improve outcomes. With positive impact for both large urban metropolitan areas and remote isolated communities.


Leveraged Funds

- Fibrinogen Concentrate (500g) will be supplied by CSL Behring. This is approximately $360,000 worth of product (1g FC = $720).
- ROTEM Sigma and Reagents will be supported by TEM International to the value of $120,000.
- GCHHS will support the study in terms of personnel to a value of $200,000. This will included top up funding to the NRG7 04 salary and additional administrative/research assistant staff wages (based at GCUH).


SHARE

Amount Awarded
$292,937


Program


Grant Scheme


Status
Active


Principal Investigator:
Dr Don Campbell


Co Investigators:
Dr Catherine Hurn
Dr James Winearls
Dr Martin Wullschleger


Associate Investigators:
Dr Jeremy Furyk
Dr Glenn Ryan
Prof Jeffrey Presneill
Prof John Fraser
A/Prof Gerben Keijzers
Megan Shuttleworth
Dr Wayne Dyer


Institution


Collaborating Institutions


CONTACT US +61 7 3720 5700 info@emfoundation.org.au 2/15 Lang Parade Milton Qld 4064