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Investigating Fibrinogen in Severe Paediatric Trauma

Gold Coast University Hospital

There is evidence that fibrinogen deficiency plays a significant role in TIC, particularly in children. The FEISTY Junior Trial therefore aims to replicate FEISTY, appropriately modified for the paediatric population of 3 months to 18 years. As there are no published studies comparing Fibrinogen Concentrate and Cryoprecipitate in the paediatric population, the aim is to develop an evidence base in paediatrics that is as robust as that in the adult setting for severe traumatic haemorrhage.

We hypothesise that fibrinogen replacement in severe traumatic haemorrhage in children can be achieved more rapidly with a more predictable dose response using Fibrinogen Concentrate compared to Cryoprecipitate.

The FEISTY Junior study will investigate the use of Fibrinogen Concentrate against currently accepted standards of fibrinogen supplementation – cryoprecipitate using an accepted viscoelastic haemostatic assay (VHA) algorithm.

Specifics of the trial

Trial Aims

– To investigate the feasibility of early fibrinogen replacement in traumatic haemorrhage utilising either FC or Cryoprecipitate in children

– Compare time to administration of fibrinogen replacement between FC and Cryoprecipitate

– To investigate the effects of fibrinogen replacement (utilising either FC or Cryoprecipitate) on fibrinogen levels during traumatic haemorrhage

– Investigating the feasibility of implementing the study protocol in a pilot multicentre study

– Use the data generated in the pilot study to inform on logistical considerations and guide planning of a large definitive multicentre study with patient centred outcome measures as primary endpoint

Trial Design

– Multi-centre (5 sites)

– Randomised controlled, un-blinded, feasibility trial

Inclusion Criteria

1. Child (3 months to < 18 years) affected by trauma

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

Exclusion Criteria

– Injury judged incompatible with survival

– Randomisation unable to occur within 6 hours of hospital admission

– Pregnancy

– Known personal or parental objection to blood products

– Known coagulation disorder (i.e. haemophilia, von Willebrand disease)

– Previous fibrinogen replacement this admission

– Pre-Trauma Centre fibrinogen replacement

– Participation in competing study


Outcome Measures

Primary Outcome Measures

(1a) Time to administration of fibrinogen replacement from time of presentation to the Trauma Centre
(1b) Feasibility of administering FC within 30 mins of clinical scenario and ROTEM analysis suggesting Fibrinogen replacement is required
(2) Effects on fibrinogen levels during traumatic haemorrhage as measured by Clauss Fibrinogen and FIBTEM analysis

Secondary Outcome Measures

(1) Transfusion requirements (in number of units or PRBC, FFP, FC, Cryoprecipitate, Platelets, PCC at 4, 6, 24, 48hrs);
(2) Duration of bleeding episode or time until surgical control and with no further requirement or coagulation factors;
(3) Duration of ICU and Hospital LOS;
(4) Duration of Mechanical ventilation;
(5) ROTEM, Multiplate, FBC, INR, APTT, FibC analysis at pre-specified time points – ED presentation OR recognition of significant haemorrhage, 10mins after intervention, as clinically indicated, after every 4 units PRBC, at ICU admission and then daily for 7 days;
(6) Specific evaluation of EXTEM CT (clotting time) during active haemorrhage and in response to fibrinogen replacement;
(7) Adverse events – TACO/TRALU/Sepsis/MOF/ARF;
(8) Thromboembolic complications;
(9) All-cause mortality at 4, 6, 24 hours and up to 90 days
(10) Functional outcomes at 30 and 90 days

Feasibility Outcome Measures

(1) Time to randomisation;
(2) FC or Cryoprecipitate wastage;
(3) Proportion of patients with blood sampling at all pre-specified time points;
(4) Number of missed patients (eligible but not enrolled);
(5) Randomisation errors;
(6) Protocol violations
(7) Follow up rates with functional outcome assessment

Collaborators and Sponsors

This is an investigator initiated, designed and driven study coordinated from Gold Coast University Hospital.

Participating Sites

Gold Coast University Hospital
Gold Coast University Hospital
Royal Brisbane Womens Hospital
Royal Brisbane and Women's Hospital
Princess Alexandra Hospital
Princess Alexandra Hospital
Townsville Hospital
Townsville Hospital
Lady Cilento Children's Hospital
Lady Cilento Children's Hospital