Trauma Clinical Trial - Fibrinogen Early In Severe Trauma studY Junior

Status Recruiting

Clinical Trial Summary

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

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03508141
Study type	Interventional
Source	Gold Coast Hospital and Health Service
Contact	James Winearls, MBBS
Phone	+61756875684
Email	james.winearls@health.qld.gov.au
Status	Recruiting
Phase	Phase 2
Start date	July 1, 2018
Completion date	June 30, 2021

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Fibrinogen Early In Severe Trauma studY Junior — FEISTY Jnr

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms