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Fibrinogen Early In Severe Trauma studY Junior

NCT03508141 — Phase 2, Unknown, 44 participants, Gold Coast Hospital and Health Service
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Fibrinogen Concentrate vs Cryoprecipitate in Traumatic Haemorrhage in Children: A Pilot Randomised Controlled Trial

RegistryNCT03508141, acronym FEISTY Jnr
StatusUnknown
PhasePhase 2
Study typeInterventional; randomized, parallel, masking: single, treatment
Enrollment44 (Estimated)
SponsorGold Coast Hospital and Health Service (Other gov); collaborators: Emergency Medicine Foundation, National Blood Authority, Australian Red Cross
ConditionsTrauma, Hemorrhage, Coagulopathy, Pediatrics
InterventionsFibrinogen Concentrate, Cryoprecipitate (Drug)
Datesstart 2018-07-01, primary completion 2021-06-30 (estimated), completion 2021-06-30 (estimated), first posted 2018-04-25, last updated 2020-06-29
Locations10 sites in Australia

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-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

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+Arms and interventions

ArmTypeInterventionsDescription
Fibrinogen ConcentrateExperimentalDrug: Fibrinogen ConcentrateFibrinogen 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
CryoprecipitateActive comparatorDrug: CryoprecipitateFibrinogen 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
  • Fibrinogen Concentrate (Drug), also known as Riastap: Experimental
  • Cryoprecipitate (Drug): Comparator

+Outcome measures

Primary outcomes

  • Time to administration of fibrinogen replacement from time of identification of hypofibrinogenaemia requiring fibrinogen replacement [3 Hours]: Time to fibrinogen replacement

Secondary outcomes

  • Transfusion Requirements [Up to 48 hours after Trauma Unit presentation]: In number of units of Packed Red Blood Cells, Plasma, FC, Cryoprecipitate, Platelets, Prothrombin Complex Concentrate at 4, 6, 24, 48hrs
  • Duration of bleeding episode or time until surgical control [It is anticipated that haemorrhage control will be achieved within 12 hours]: Duration bleeding episode
  • Intensive Care Unit LOS [1 Year]: ICU LOS
  • Hospital LOS [1 Year]: Hospital LOS
  • Adverse Events [1 Year]: Transfusion related adverse events, Sepsis, Multiple Organ Failure, Acute Renal Failure, Symptomatic Thromboembolic Complications
  • All Cause Mortality [Up to 90 Days]: Mortality at 4, 6, 24 hours and up to 90 days
  • Functional Outcomes GOS-E Paediatrics [Up to 90 Days]: Functional Outcome Measures at 60 and 90 Days

+Eligibility

Sex: All, ages: 3 Months to 18 Years

Inclusion Criteria:

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

Exclusion Criteria:

1. Injury judged incompatible with survival
2. Randomisation unable to occur within 6 hours of hospital admission
3. Pregnancy
4. Known personal or parental objection to blood products
5. Known coagulation disorder (i.e. haemophilia, von Willebrand disease)
6. Previous dedicated fibrinogen replacement this admission
7. Pre-Trauma Centre dedicated fibrinogen replacement
8. Participation in competing study

+Locations (10)

FacilityCityCountryStatus
Westmead Childrens HospitalSydney, New South WalesAustraliaRecruiting
Royal Brisbane and Women's HospitalBrisbane, QueenslandAustraliaRecruiting
Lady Cilento Children's HospitalBrisbane, QueenslandAustraliaRecruiting
Princess Alexandra HospitalBrisbane, QueenslandAustraliaRecruiting
Cairns HospitalCairns, QueenslandAustraliaRecruiting
Gold Coast University HospitalGold Coast, QueenslandAustraliaRecruiting
Mackay Base HospitalMackay, QueenslandAustraliaRecruiting
Rockhampton HospitalRockhampton, QueenslandAustraliaRecruiting
Townsville HospitalTownsville, QueenslandAustraliaRecruiting
Royal Adelaide HospitalAdelaide, South AustraliaAustraliaRecruiting

+Publications

  • Results publication: George S, Wake E, Jansen M, Roy J, Maconachie S, Paasilahti A, Wiseman G, Gibbons K, Winearls J; FEISTY Investigators. Fibrinogen Early In Severe paediatric Trauma studY (FEISTY junior): protocol for a randomised controlled trial. BMJ Open. 2022 May 4;12(5):e057780. doi: 10.1136/bmjopen-2021-057780. PMID 35508351

+Investigators

My Notes