Fibrinogen Early In Severe Trauma studY

Summary

* Haemorrhage in severe trauma is a significant cause of mortality and is potentially the most preventable cause of death in trauma patients * Trauma Induced Coagulopathy (TIC) is a complex coagulopathy associated with severe trauma * Hypo/dysfibrinogenaemia plays an important role in TIC * Early replacement of fibrinogen may improve outcomes * Fibrinogen replacement is potentially inadequate in standard fixed ratio Major Haemorrhage Protocols (MHP) utilising Plasma and/or Cryoprecipitate * The majority of centres utilise cryoprecipitate for additional fibrinogen supplementation as part of a MHP * Cryoprecipitate administration is often delayed (between 60 - 120 minutes) in a fixed ratio MHP * It is clear early intervention in severe traumatic haemorrhage is associated with improved outcomes - CRASH 2 and PROPPR studies * Increasing interest in the use of Fibrinogen Concentrate (FC) in severe bleeding but not supported by high level evidence * Benefits of FC - viral inactivation, known dose, easily reconstituted, can be administered quickly in high dose and stored at room temperature in the trauma resuscitation bay * No previous studies comparing FC and Cryoprecipitate in bleeding trauma patients * Fibrinogen supplementation will be guided by an accepted ROTEM targeted treatment algorithm * It will be a pilot, multi-centre randomised controlled trial comparing FC to Cryoprecipitate (current standard practise in fibrinogen supplementation) * Hypothesis: Fibrinogen replacement in severe traumatic haemorrhage can be achieved quicker with a more predictable dose response using Fibrinogen Concentrate compared to Cryoprecipitate * It is imperative that robust and clinically relevant trials are performed to investigate fibrinogen supplementation in trauma before widespread adoption makes performing such studies unfeasible

Timeline

Start

2016-12

Primary completion

2018-01-20

Completion

2018-02-20

Publications

• Morrow GB, Feller T, McQuilten Z, Wake E, Ariens RAS, Winearls J, Mutch NJ, Laffan MA, Curry N. Cryoprecipitate transfusion in trauma patients attenuates hyperfibrinolysis and restores normal clot structure and stability: Results from a laboratory sub-study of the FEISTY trial. Crit Care. 2022 Sep 26;26(1):290. doi: 10.1186/s13054-022-04167-x.
• Winearls J, Wullschleger M, Wake E, Hurn C, Furyk J, Ryan G, Trout M, Walsham J, Holley A, Cohen J, Shuttleworth M, Dyer W, Keijzers G, Fraser JF, Presneill J, Campbell D. Fibrinogen Early In Severe Trauma studY (FEISTY): study protocol for a randomised controlled trial. Trials. 2017 May 26;18(1):241. doi: 10.1186/s13063-017-1980-x.

Drugs

Indications