Winearls James, Wullschleger Martin, Wake Elizabeth, Hurn Catherine, Furyk Jeremy, Ryan Glenn, Trout Melita, Walsham James, Holley Anthony, Cohen Jeremy, Shuttleworth Megan, Dyer Wayne, Keijzers Gerben, Fraser John F, Presneill Jeffrey, Campbell Don
Gold Coast University Hospital, Southport, QLD, Australia.
School of Medicine, University of Queensland, St. Lucia, QLD, Australia.
Trials. 2017 May 26;18(1):241. doi: 10.1186/s13063-017-1980-x.
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.
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.
ClinicalTrials.gov, ID: NCT02745041 . Registered 4 May 2016.
出血是严重创伤导致死亡的主要原因。纤维蛋白原在创伤性出血的止血过程中起着关键作用。多项国际创伤指南推荐早期使用纤维蛋白原浓缩剂（FC）或冷沉淀（Cryo）替代纤维蛋白原。目前支持某一种产品优于另一种产品的证据有限，且在实践中存在广泛的地域和机构差异。这项先导试验是第一项比较FC和Cryo用于创伤性出血的随机对照试验。
方法/设计：严重创伤早期纤维蛋白原研究（FEISTY）是一项探索性、多中心、随机对照试验，比较FC和Cryo用于创伤性出血时补充纤维蛋白原的效果。本试验将采用血栓弹力图（ROTEM®）来指导和确定纤维蛋白原补充剂量。该试验将在澳大利亚的四个主要创伤中心招募100名创伤患者。有出血证据的成年创伤患者将在抵达创伤病房时入组，并随机接受FC或Cryo补充纤维蛋白原。主要结局是补充纤维蛋白原的差异时间。还有一些预先确定的次要结局，包括：干预对血浆纤维蛋白原水平的影响、可行性评估以及包括输血需求和死亡率在内的临床结局。
创伤性出血时替代纤维蛋白原的最佳方法存在激烈争论。在本试验中，将比较使用FC补充纤维蛋白原与使用Cryo的可行性和疗效。这项先导研究的结果将有助于设计一项更大型的试验，该试验有足够的效力来解决以患者为中心的结局问题。
ClinicalTrials.gov，标识符：NCT02745041。于2016年5月4日注册。
