Trauma Clinical Trial
— FEISTY JnrOfficial title:
Fibrinogen Concentrate vs Cryoprecipitate in Traumatic Haemorrhage in Children: A Pilot Randomised Controlled Trial
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
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Gold Coast Hospital and Health Service | Australian Red Cross, Emergency Medicine Foundation, National Blood Authority |
Australia,
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 |
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