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Fibrinogen Early In Severe paediatric Trauma studY (FEISTY junior): protocol for a randomised controlled trial
Shane George1,2,3, Elizabeth Wake4,5, Melanie Jansen6,7
1Departments of Emergency Medicine and Children's Critical Care, Gold Coast University Hospital, Southport, Queensland, Australia shane.george@uq.edu.au.
Insights
This study investigates fibrinogen concentrate (FC) versus cryoprecipitate for treating trauma-induced coagulopathy in children. Early fibrinogen replacement may improve outcomes and reduce blood product reliance.
Area of Science:
- Trauma care
- Pediatric critical care
- Hematology
Background:
- Hemorrhage is a leading cause of death in pediatric trauma patients.
- Trauma-induced coagulopathy (TIC) involves fibrinogen and platelets, but mechanisms are unclear.
- Early recognition and treatment of coagulopathy are crucial for improving outcomes.
Purpose of the Study:
- To assess the feasibility of a randomized trial comparing fibrinogen concentrate (FC) and cryoprecipitate for pediatric trauma.
- To evaluate the time to fibrinogen replacement in severely injured children.
- To explore the potential of viscoelastic hemostatic assays in guiding treatment.
Main Methods:
- Prospective, multicenter, open-label, randomized feasibility study.
- Inclusion of severely injured children (3 months-18 years) with traumatic hemorrhage.
- Allocation to FC or cryoprecipitate if FIBTEM A5 ≤10, guided by a standardized algorithm.
Main Results:
- The study is a feasibility trial, results on efficacy are pending.
- Primary outcome: time to fibrinogen replacement.
- Secondary outcomes: clinical and feasibility measures.
Conclusions:
- Early fibrinogen replacement guided by viscoelastic assays shows promise for pediatric trauma.
- FC offers potential advantages for remote centers lacking cryoprecipitate.
- This research may reduce transfusion needs and improve trauma care equity.
Introduction:
Trauma causes 40% of child deaths in high-income countries, with haemorrhage being a leading contributor to death in this population. There is a growing recognition that fibrinogen and platelets play a major role in trauma-induced coagulopathy (TIC) but the exact physiological mechanisms are poorly understood.
Methods And Analysis:
This is a prospective multicentre, open-label, randomised, two-arm parallel feasibility study conducted in the emergency departments, intensive care units and operating theatres of participating hospitals. Severely injured children, aged between 3 months and 18 years, presenting with traumatic haemorrhage requiring transfusion of blood products will be screened for inclusion.Sixty-eight patients will be recruited and will be allocated to fibrinogen replacement using fibrinogen concentrate (FC) or cryoprecipitate in a 1:1 ratio. Fibrinogen replacement will be administered to patients with a FIBTEM A5 of ≤10. All other aspects of the currently used rotational thromboelastometry-guided treatment algorithm and damage-control approach to trauma remain the same in both groups.The primary outcome is time to administration of fibrinogen replacement from time of identification of hypofibrinogenaemia. Clinical secondary outcomes and feasibility outcomes will also be analysed.
Ethics And Dissemination:
This study has received ethical clearance from the Children's Health Queensland Human Research Ethics Committee (HREC/17/QRCH/78). Equipment and consumables for sample testing have been provided to the study by Haemoview Diagnostics, Werfen Australia and Haemonetics Australia. FC has been provided by CSL Behring, Australia. The funding bodies and industry partners have had no input into the design of the study, and will not be involved in the preparation or submission of the manuscript for publication.The use of viscoelastic haemostatic assays and early fibrinogen replacement has the potential to improve outcomes in paediatric trauma through earlier recognition of TIC. This in turn may reduce transfusion volumes and downstream complications and reduce the reliance on donor blood products such as cryoprecipitate.The use of FC has implications for regional and remote centres who would not routinely have access to cryoprecipitate but could store FC easily. Access to early fibrinogen replacement in these centres could make a significant impact and assist in closing the gap in trauma care available to residents of these communities.Outcomes of this study will be submitted for publication in peer-reviewed journals and submitted for presentation at national and international scientific fora.
Trial Registration Number:
NCT03508141.
