Fibrinogen Early In Severe Trauma studY Junior

Trauma Clinical Trial

— FEISTY Jnr  

Official title:

Fibrinogen Concentrate vs Cryoprecipitate in Traumatic Haemorrhage in Children: A Pilot Randomised Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03508141
• Other study ID #: FEISTY Jnr 1
• Status: Recruiting
• Phase: Phase 2
• Start date: July 1, 2018
• Est. completion date: June 30, 2021

Study information

• Verified date: June 2020
• Source: Gold Coast Hospital and Health Service
• Contact: James Winearls, MBBS
• Phone: +61756875684
• Email: james.winearls[@]health.qld.gov.au
• Is FDA regulated: No
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Coagulopathy
• Hemorrhage
• Pediatrics
• Trauma

Intervention

Drug:
• Fibrinogen Concentrate
Experimental
• Cryoprecipitate
Comparator

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Lady Cilento Children's Hospital	Brisbane	Queensland
Australia	Princess Alexandra Hospital	Brisbane	Queensland
Australia	Royal Brisbane and Women's Hospital	Brisbane	Queensland
Australia	Cairns Hospital	Cairns	Queensland
Australia	Gold Coast University Hospital	Gold Coast	Queensland
Australia	Mackay Base Hospital	Mackay	Queensland
Australia	Rockhampton Hospital	Rockhampton	Queensland
Australia	Westmead Childrens Hospital	Sydney	New South Wales
Australia	Townsville Hospital	Townsville	Queensland

Sponsors (4)

Lead Sponsor	Collaborator
Gold Coast Hospital and Health Service	Australian Red Cross, Emergency Medicine Foundation, National Blood Authority

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to administration of fibrinogen replacement from time of identification of hypofibrinogenaemia requiring fibrinogen replacement	Time to fibrinogen replacement	3 Hours
Secondary	Transfusion Requirements	In number of units of Packed Red Blood Cells, Plasma, FC, Cryoprecipitate, Platelets, Prothrombin Complex Concentrate at 4, 6, 24, 48hrs	Up to 48 hours after Trauma Unit presentation
Secondary	Duration of bleeding episode or time until surgical control	Duration bleeding episode	It is anticipated that haemorrhage control will be achieved within 12 hours
Secondary	Intensive Care Unit LOS	ICU LOS	1 Year
Secondary	Hospital LOS	Hospital LOS	1 Year
Secondary	Adverse Events	Transfusion related adverse events, Sepsis, Multiple Organ Failure, Acute Renal Failure, Symptomatic Thromboembolic Complications	1 Year
Secondary	All Cause Mortality	Mortality at 4, 6, 24 hours and up to 90 days	Up to 90 Days
Secondary	Functional Outcomes GOS-E Paediatrics	Functional Outcome Measures at 60 and 90 Days	Up to 90 Days