Clinical trial NCT03508141: Fibrinogen Early In Severe Trauma studY Junior
Official title: Fibrinogen Concentrate vs Cryoprecipitate in Traumatic Haemorrhage in Children: A Pilot Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Trauma
Hemorrhage
Coagulopathy
Pediatrics
Keywords: Fibrinogen Concentrate
Cryoprecipitate
Lead sponsor: Gold Coast Hospital and Health Service
Sponsor class: OTHER_GOV
Collaborators: name: Emergency Medicine Foundation
name: National Blood Authority
name: Australian Red Cross
First posted: 2018-04-25
Enrollment: 44
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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


Eligibility criteria: 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

Primary outcomes:
measure: Time to administration of fibrinogen replacement from time of identification of hypofibrinogenaemia requiring fibrinogen replacement
timeFrame: 3 Hours
Secondary outcomes:
measure: Transfusion Requirements
timeFrame: Up to 48 hours after Trauma Unit presentation
measure: Duration of bleeding episode or time until surgical control
timeFrame: It is anticipated that haemorrhage control will be achieved within 12 hours
measure: Intensive Care Unit LOS
timeFrame: 1 Year
measure: Hospital LOS
timeFrame: 1 Year
measure: Adverse Events
timeFrame: 1 Year
measure: All Cause Mortality
timeFrame: Up to 90 Days
measure: Functional Outcomes GOS-E Paediatrics
timeFrame: Up to 90 Days
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Westmead Childrens Hospital
state: New South Wales
city: Brisbane
country: Australia
facility: Royal Brisbane and Women's Hospital
state: Queensland
city: Brisbane
country: Australia
facility: Lady Cilento Children's Hospital
state: Queensland
city: Brisbane
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Cairns
country: Australia
facility: Cairns Hospital
state: Queensland
city: Gold Coast
country: Australia
facility: Gold Coast University Hospital
state: Queensland
city: Mackay
country: Australia
facility: Mackay Base Hospital
state: Queensland
city: Rockhampton
country: Australia
facility: Rockhampton Hospital
state: Queensland
city: Townsville
country: Australia
facility: Townsville Hospital
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
Study officials:
affiliation: Lady Cilento Children's Hospital
name: Shane George, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.