NCT03508141: FEISTY Jnr

Fibrinogen Early In Severe Trauma studY Junior

Status unknown Phase 2 Last updated 29 June 2020

What this trial tests

Phase 2 trial testing Fibrinogen Concentrate in Trauma in 44 participants. Status unknown.

Timeline

1 July 2018

Primary endpoint
30 June 2021

30 June 2021

Quick facts

Lead sponsor	Gold Coast Hospital and Health Service
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	44
Start date	1 July 2018
Primary completion	30 June 2021
Estimated completion	30 June 2021
Sites	10 locations across Australia

Drugs / interventions tested

• Fibrinogen Concentrate — full drug profile →
• Cryoprecipitate — full drug profile →

Conditions studied

• Trauma — all drugs for Trauma →
• Hemorrhage — all drugs for Hemorrhage →
• Coagulopathy — all drugs for Coagulopathy →
• Pediatrics — all drugs for Pediatrics →

Sponsor

Gold Coast Hospital and Health Service

Who can join

Adults 3 Months to 18, any sex, with Trauma or Hemorrhage. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

1. Haemorrhage in severe trauma is a significant cause of mortality and is potentially the most preventable cause of death in paediatric trauma patients
2. Trauma Induced Coagulopathy (TIC) is a complex coagulopathy associated with severe trauma
3. Hypo/dysfibrinogenaemia plays an important role in TIC
4. Early replacement of fibrinogen may improve outcomes
5. Fibrinogen replacement is potentially inadequate in standard fixed ratio Major Haemorrhage Protocols (MHP) utilising Plasma and/or Cryoprecipitate
6. The majority of centres utilise cryoprecipitate for additional fibrinogen supplementation as part of a MHP
7. Cryoprecipitate administration is often delayed (between 60 - 120 minutes) in a fixed ratio MHP
8. It is clear early intervention in severe traumatic haemorrhage is associated with improved outcomes - CRASH 2 and PROPPR studies
9. Increasing interest in the use of Fibrinogen Concentrate (FC) in severe bleeding but not supported by high level evidence
10. 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

12\. No previous studies comparing FC and Cryoprecipitate in bleeding paediatric trauma patients 13. Fibrinogen supplementation will be guided by an accepted ROTEM targeted treatment algorithm 14. Pilot, multi-centre randomised controlled trial comparing FC to Cryoprecipitate (current standard practise in fibrinogen supplementation) 15. Hypothesis: Fibrinogen replacement in severe traumatic haemorrhage can be achieved quicker with a more predictable dose response using Fibrinogen Concentrate compared to Cryoprecipitate 16. It is imperative that robust and clinically relevant trials are performed to investigate fibrinogen supplementation in paediatric trauma patients before widespread adoption makes performing such studies unfeasible

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Fibrinogen Early In Severe Trauma studY (FEISTY): results from an Australian multicentre randomised controlled pilot trial.
   Winearls J, Wullschleger M, Wake E, McQuilten Z, et al · · 2021 · cited 36× · PMID 38046391 · DOI 10.51893/2021.1.oa3
2. Recent advances in use of fresh frozen plasma, cryoprecipitate, immunoglobulins, and clotting factors for transfusion support in patients with hematologic disease.
   Nair PM, Rendo MJ, Reddoch-Cardenas KM, Burris JK, et al · · 2020 · cited 19× · PMID 32892846 · DOI 10.1053/j.seminhematol.2020.07.006
3. Fibrinogen Early In Severe paediatric Trauma studY (FEISTY junior): protocol for a randomised controlled trial.
   George S, Wake E, Jansen M, Roy J, et al · · 2022 · cited 5× · PMID 35508351 · DOI 10.1136/bmjopen-2021-057780