Trauma, Hemorrhage, Coagulopathy, Pediatrics
Conditions
Keywords
Fibrinogen Concentrate, Cryoprecipitate
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
Interventions
Experimental
DRUGCryoprecipitate
Comparator
Sponsors
Emergency Medicine Foundation
National Blood Authority
Australian Red Cross
Gold Coast Hospital and Health Service
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Months to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to administration of fibrinogen replacement from time of identification of hypofibrinogenaemia requiring fibrinogen replacement | 3 Hours | Time to fibrinogen replacement |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| Adverse Events | 1 Year | Transfusion related adverse events, Sepsis, Multiple Organ Failure, Acute Renal Failure, Symptomatic Thromboembolic Complications |
Countries
Australia
Contacts
Primary ContactJames Winearls, MBBS
Backup ContactElizabeth Wake, BN
Outcome results
None listed