Information for Patients

Why are we conducting the FEISTY study?

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.

The FEISTY study will investigate the feasibility of administering fibrinogen replacement rapidly to the severely injured trauma patient. The results of this study will be used to plan a larger study to investigate if theses treatments can reduce death rates in severely bleeding trauma patients.

Gold Coast University Hospital Helipad - FEISTY Study

What is the aim of the FEISTY study?

The aim of the study is to investigate the feasibility and efficacy of replacing fibrinogen in severely bleeding trauma patients using either Fibrinogen Concentrate or Cryoprecipitate.

What is being investigated?

The study is investigating the possibility that early fibrinogen replacement using Fibrinogen Concentrate, which is a concentrated form of fibrinogen that is manufactured from human sources of plasma, will achieve a quicker and more predictable response that current treatment options.

Which patients can take part?

Any adult patient suffering severe trauma who is critically bleeding. A highly experienced clinician determines if the patient is eligible for the study. Participating hospitals will recruit patients directly.

What does the FEISTY study involve for patients?

One group of patients will receive fibrinogen replacement using Fibrinogen Concentrate and the other Cryoprecipitate. The effects of the two different treatments will be assessed, focusing on blood test results of fibrinogen levels and clinical outcomes such as bleeding, organ failure and length of stay in hospital