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dc.contributor.authorWinearls, J
dc.contributor.authorWullschleger, M
dc.contributor.authorWake, E
dc.contributor.authorHurn, C
dc.contributor.authorFuryk, J
dc.contributor.authorRyan, G
dc.contributor.authorTrout, M
dc.contributor.authorWalsham, J
dc.contributor.authorHolley, A
dc.contributor.authorCohen, J
dc.contributor.authorShuttleworth, M
dc.contributor.authorDyer, W
dc.contributor.authorKeijzers, G
dc.contributor.authorFraser, JF
dc.contributor.authorPresneill, J
dc.contributor.authorCampbell, D
dc.date.accessioned2021-02-04T01:47:41Z
dc.date.available2021-02-04T01:47:41Z
dc.date.issued2017-05-26
dc.identifierpii: 10.1186/s13063-017-1980-x
dc.identifier.citationWinearls, J., Wullschleger, M., Wake, E., Hurn, C., Furyk, J., Ryan, G., Trout, M., Walsham, J., Holley, A., Cohen, J., Shuttleworth, M., Dyer, W., Keijzers, G., Fraser, J. F., Presneill, J. & Campbell, D. (2017). Fibrinogen Early In Severe Trauma studY (FEISTY): study protocol for a randomised controlled trial. TRIALS, 18 (1), https://doi.org/10.1186/s13063-017-1980-x.
dc.identifier.issn1745-6215
dc.identifier.urihttp://hdl.handle.net/11343/259478
dc.description.abstractBACKGROUND: 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. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT02745041 . Registered 4 May 2016.
dc.languageEnglish
dc.publisherBMC
dc.rights.urihttps://creativecommons.org/licenses/by/4.0
dc.titleFibrinogen Early In Severe Trauma studY (FEISTY): study protocol for a randomised controlled trial
dc.typeJournal Article
dc.identifier.doi10.1186/s13063-017-1980-x
melbourne.affiliation.departmentMedicine (St Vincent's)
melbourne.affiliation.departmentCritical Care
melbourne.affiliation.facultyMedicine, Dentistry & Health Sciences
melbourne.source.titleTrials
melbourne.source.volume18
melbourne.source.issue1
dc.rights.licenseCC BY
melbourne.elementsid1213549
melbourne.contributor.authorCampbell, Duncan
melbourne.contributor.authorPresneill, Jeffrey
dc.identifier.eissn1745-6215
melbourne.accessrightsOpen Access


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