Trial | NCT03508141  Report issue

Title

Fibrinogen Early In Severe Trauma studY Junior
Fibrinogen Concentrate vs Cryoprecipitate in Traumatic Haemorrhage in Children: A Pilot Randomised Controlled Trial

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    44
Haemorrhage in severe trauma is a significant cause of mortality and is potentially the most preventable cause of death in paediatric 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

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
Study Started
Jul 01
2018
Primary Completion
Jun 30
2021
Anticipated
Study Completion
Jun 30
2021
Anticipated
Last Update
Jun 29
2020

Drug Fibrinogen Concentrate

Experimental

  • Other names: Riastap

Drug Cryoprecipitate

Comparator

Fibrinogen Concentrate Experimental

Fibrinogen Replacement using Fibrinogen Concentrate as per ROTEM (FIBTEM) FIBTEM A5 0mm = 60mg/kg FC FIBTEM A5 1-4mm = 50mg/kg FC FIBTEM A5 5-6mm = 40mg/kg FC FIBTEM A5 7-8mm = 30mg/kg FC FIBTEM A5 9-10mm = 20mg/kg FC

Cryoprecipitate Active Comparator

Fibrinogen Replacement using Cryoprecipitate as per ROTEM (FIBTEM) FIBTEM A5 0mm = 6ml/kg Cryoprecipitate FIBTEM A5 1-4mm = 5ml/kg Cryoprecipitate FIBTEM A5 5-6mm = 4ml/kg Cryoprecipitate FIBTEM A5 7-8mm = 3ml/kg Cryoprecipitate FIBTEM A5 9-10mm = 2ml/kg Cryoprecipitate

Criteria 

Inclusion Criteria:

Child affected by trauma (3 months to 18 years)
Judged to have significant haemorrhage OR predicted to require significant transfusion by the treating clinician
Activation of Local MHP or transfusion of emergency red blood cells (Pre-hospital or at Trauma Centre)

Exclusion Criteria:

Injury judged incompatible with survival
Randomisation unable to occur within 6 hours of hospital admission
Pregnancy
Known personal or parental objection to blood products
Known coagulation disorder (i.e. haemophilia, von Willebrand disease)
Previous dedicated fibrinogen replacement this admission
Pre-Trauma Centre dedicated fibrinogen replacement
Participation in competing study
No Results Posted