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RecruitingPhase 2ACTRN12623000812695

Efficacy and safety of prehospital fibrinogen early in severe trauma study: A feasibility phase II study (PRE-FEISTY II) (Stage 1).

Efficacy and safety of prehospital fibrinogen early in severe trauma study: A fphase II study (PRE-FEISTY II)(Stage 1)

Sponsor

New South Wales Ambulance

Enrollment

23 participants

Start Date

Dec 10, 2023

Study Type

Interventional

Conditions

Acute traumatic haemorrhage

Summary

This study aims to investigate the feasibility and effect of administering fibrinogen concentrate in the setting of severe traumatic bleeding in the prehospital setting, This is being done to evaluate the possibility of conducting a prehospital arm of the forthcoming FEISTY II study.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria3

  • Adult patient (aged greater than or equal to 18 years).
  • Judged to have ongoing haemorrhage by the treating clinician.
  • Receiving pre-hospital blood transfusion

Exclusion Criteria7

  • Injury judged incompatible with survival
  • Enrolment unable to occur within 6 hours of injury
  • Known pregnancy
  • Known genetic or drug induced coagulation disorder
  • Known objection to blood products
  • Dedicated prior fibrinogen replacement
  • Participation in a competing study

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Interventions

Intravenous or intraosseous administration of three vials (approximately 3g) of fibrinogen concentrate (RiaStap®) following the conclusion of initial resuscitation and stabilisation, anticipated to be

Intravenous or intraosseous administration of three vials (approximately 3g) of fibrinogen concentrate (RiaStap®) following the conclusion of initial resuscitation and stabilisation, anticipated to be in the timeframe of approximately 15 to 60 minutes following arrival of a prehospital medical team. The intervention will be delivered once. Adherence to the intervention will be monitored by regular ongoing audit of all patients treated by our service who receive prehospital blood transfusion. This audit is already embedded in our routine clinical governance procedures.

Locations(4)

NSW Ambulance Aeromedical Operations- Bankstown Base - Condell Park

NSW,QLD, Australia

NSW Ambulance Aeromedical Operations- Wollongong Base - Albion Park Rail

NSW,QLD, Australia

NSW Ambulance Aeromedical Operations- Orange Base - Huntley

NSW,QLD, Australia

Lismore Retrieval Service Helicopter Base - Loftville

NSW,QLD, Australia

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ACTRN12623000812695