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  • Fibrinogen Early In Severe Trauma studY (FEISTY): results from an Australian multicentre randomised controlled pilot trial

    Author(s)
    Winearls, James
    Wullschleger, Martin
    Wake, Elizabeth
    McQuilten, Zoe
    Reade, Michael
    Hurn, Catherine
    Ryan, Glenn
    Trout, Melita
    Walsham, James
    Holley, Anthony
    George, Shane
    Dyer, Wayne
    McCullough, James
    Keijzers, Gerben
    Fraser, John
    et al.
    Griffith University Author(s)
    Wullschleger, Martin
    Keijzers, Gerben
    Fraser, John F.
    George, Shane A.
    Wake, Liz
    Campbell, Donald G.
    Year published
    2021
    Metadata
    Show full item record
    Abstract
    Background: Haemorrhage is a major cause of death in severe trauma. Fibrinogen plays a critical role in maintaining haemostasis in traumatic haemorrhage, and early replacement using fibrinogen concentrate (FC) or cryoprecipitate (Cryo) is recommended by several international trauma guidelines. Limited evidence supports one product over the other, with widespread geographic and institutional variation in practice. Two previous trials have investigated the feasibility of rapid FC administration in severely injured trauma patients, with conflicting results. <br /><br />Objective: To compare the time to fibrinogen replacement ...
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    Background: Haemorrhage is a major cause of death in severe trauma. Fibrinogen plays a critical role in maintaining haemostasis in traumatic haemorrhage, and early replacement using fibrinogen concentrate (FC) or cryoprecipitate (Cryo) is recommended by several international trauma guidelines. Limited evidence supports one product over the other, with widespread geographic and institutional variation in practice. Two previous trials have investigated the feasibility of rapid FC administration in severely injured trauma patients, with conflicting results. <br /><br />Objective: To compare the time to fibrinogen replacement using FC or Cryo in severely injured trauma patients with major haemorrhage and hypofibrinogenaemia. Design, setting, patients and interventions: A multicentre controlled pilot trial in which adult trauma patients with haemorrhage were randomly assigned (1:1) to receive FC or Cryo for fibrinogen replacement, guided by FIBTEM A5 (functional fibrinogen assessment at 5 minutes after clot formation, using rotational thromboelastometry). <br /><br />Main outcome measures: The primary outcome was time to commencement of fibrinogen replacement. Secondary outcomes included effects of the intervention on plasma fibrinogen levels and clinical outcomes including transfusion requirements and mortality. <br /><br />Results: Of the 100 randomly assigned patients, 62 were hypofibrinogenaemic and received the intervention (n = 37) or Cryo (n = 25). Median (interquartile range [IQR]) time to delivery of FC was 29 min (23-40 min) compared with 60 min (40- 80 min) for Cryo (P = 0.0001). All 62 patients were hypofibrinogenaemic before receiving FC or Cryo (FC: median FIBTEM A5, 8 mm [IQR, 7-9 mm]; Cryo: median FIBTEM A5, 9 mm [IQR, 5-10 mm]). In the FC arm patients received a median of 3 g FC (IQR, 2-4 g), and in the Cryo arm patients received a median of 8 units of Cryo (IQR, 8-14 units). Restoration of fibrinogen levels was achieved in both arms after the intervention. Blood product transfusion, fluid resu
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    Journal Title
    Critical care and resuscitation
    Volume
    23
    Issue
    1
    Publisher URI
    https://ccr.cicm.org.au/journal-editions/2021/march/toc-march-2021/original-articles/article-6
    Subject
    Clinical sciences
    Nursing
    Science & Technology
    Life Sciences & Biomedicine
    Critical Care Medicine
    General & Internal Medicine
    Publication URI
    http://hdl.handle.net/10072/406585
    Collection
    • Journal articles

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