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Fibrinogen Early In Severe Trauma studY (FEISTY): Study protocol for a randomised controlled trial

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Version 1 2021-09-28, 08:20
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posted on 2024-06-05, 04:06 authored by J Winearls, M Wullschleger, E Wake, C Hurn, Jeremy FurykJeremy Furyk, G Ryan, M Trout, J Walsham, A Holley, J Cohen, M Shuttleworth, W Dyer, G Keijzers, JF Fraser, J Presneill, D Campbell
Background: Haemorrhage is a leading cause of death in severe trauma. Fibrinogen plays a critical role in maintaining haemostasis in traumatic haemorrhage. Early fibrinogen replacement is recommended by several international trauma guidelines using either fibrinogen concentrate (FC) or cryoprecipitate (Cryo). There is limited evidence to support one product over the other with widespread geographic and institutional variation in practice. This pilot trial is the first randomised controlled trial comparing FC to Cryo in traumatic haemorrhage. Methods/design: The Fibrinogen Early In Severe Trauma studY (FEISTY) is an exploratory, multicentre, randomised controlled trial comparing FC to Cryo for fibrinogen supplementation in traumatic haemorrhage. This trial will utilise thromboelastometry (ROTEM®) to guide and dose fibrinogen supplementation. The trial will recruit 100 trauma patients at four major trauma centres in Australia. Adult trauma patients with evidence of haemorrhage will be enrolled on arrival in the trauma unit and randomised to receiving fibrinogen supplementation with either FC or Cryo. The primary outcome is the differential time to fibrinogen supplementation. There are a number of predetermined secondary outcomes including: effects of the intervention on plasma fibrinogen levels, feasibility assessments and clinical outcomes including transfusion requirements and mortality. Discussion: The optimal method for replacing fibrinogen in traumatic haemorrhage is fiercely debated. In this trial the feasibility and efficacy of fibrinogen supplementation using FC will be compared to Cryo. The results of this pilot study will facilitate the design of a larger trial with sufficient power to address patient-centred outcomes

History

Journal

Trials

Volume

18

Article number

241

Pagination

1-11

Location

London, Eng.

Open access

  • Yes

eISSN

1745-6215

Language

eng

Publication classification

C1 Refereed article in a scholarly journal

Publisher

BioMed Central

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