Fibrinogen Early In Severe Trauma studY Junior (FEISTY Jnr)

Gold Coast Hospital and Health Service

Status and phase: Unknown; Phase 2

Conditions: Pediatrics; Coagulopathy; Hemorrhage; Trauma

Treatments: Drug: Fibrinogen Concentrate; Drug: Cryoprecipitate

Study type: Interventional

Funder types: Other

Identifiers

NCT03508141

FEISTY Jnr 1

Details and patient eligibility

About

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

11. 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

Enrollment: 44 estimated patients

Sex: All

Ages: 3 months to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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44 participants in 2 patient groups

Fibrinogen Concentrate

Experimental group

Description:

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

Treatment:

Drug: Fibrinogen Concentrate

Cryoprecipitate

Active Comparator group

Description:

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

Treatment:

Drug: Cryoprecipitate