Fibrinogen in the initial resuscitation of severe trauma (FiiRST): a randomized feasibility trial

Nascimento, Bruno; Arnold, Donald M.; Tien, Homer; Peng, Haiping; Rizoli, Sandro; Karanicolas, Paul J.; Alam, Asim; Xiong, Wei; Selby, R.; Garzon, A-m; Colavecchia, C.; Howald, R.; Nathens, Avery B.; Beckett, A.

doi:10.1093/bja/aew343

Cited by 81 publications

(45 citation statements)

References 41 publications

(45 reference statements)

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“…FC can be stored in the trauma bay, rapidly reconstituted and administered. The recently published FiiRST trial that reports early FC use is feasible and increases plasma fibrinogen levels during traumatic haemorrhage [40]. The recently completed, but not yet published, E-FIT trial (ISRCTN67540073) investigated empiric fixed-dose FC delivery in severe trauma in addition to standard MHPs, with time to delivery of FC as the primary endpoint.…”

Section: Discussionmentioning

confidence: 99%

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

Winearls

Wullschleger

Wake³

et al. 2017

Trials

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BackgroundHaemorrhage 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/designThe 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.DiscussionThe 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 registrationClinicalTrials.gov, ID: NCT02745041. Registered 4 May 2016.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-017-1980-x) contains supplementary material, which is available to authorized users.

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“…A number of studies have investigated the time to administration of fibrinogen replacement and have compared FC to cryoprecipitate but as yet there have been no large studies powered for patient‐centred outcomes or reduction in blood product usage . Systems that achieve early and rapid fibrinogen replacement generally involve empiric delivery of FC to patients presenting with clinical indications of severe bleeding, not those exclusively with a low fibrinogen level . Empiric, immediate transfusion therapy such as the early coagulation support protocol, which provides FC to patients meeting clinical parameters on presentation and before ROTEM or SLT results, have been able to reduce the administration time to under 30 min .…”

Section: Methodsmentioning

confidence: 99%

Viscoelastic haemostatic assays and fibrinogen in paediatric acute traumatic coagulopathy: A comprehensive review

Maconachie

Jansen

Cottle

et al. 2020

Emergency Medicine Australasia

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Objective Haemorrhage in paediatric trauma remains a significant cause of morbidity and mortality. Over recent years there has been increasing attention to the role of fibrinogen in traumatic haemorrhage and the association of low fibrinogen levels with poor patient outcomes. In addition, there has been a move towards using viscoelastic haemostatic assays (VHAs) to rapidly assess coagulation status and guide clinicians in the replacement of coagulation factors, including fibrinogen. In the paediatric population, there has been limited uptake of these principles and a paucity of data to support a change in practice. This paper summarises the available evidence in the published literature through a systematic review, presented in narrative format. Results There is limited high‐quality prospective data on the use of VHA in the management of acute traumatic coagulopathy in the paediatric population. While the use of fibrinogen early in major haemorrhage is becoming standard practice, there are currently no randomised prospective studies comparing fibrinogen concentrate to cryoprecipitate. Conclusions The early identification of hypo‐fibrinogenemia and acute traumatic coagulopathy in paediatric trauma using VHA testing and subsequent early fibrinogen replacement with a concentrated off the shelf product is an attractive treatment option. However, there is currently insufficient high‐level evidence to support the use of fibrinogen concentrate over cryoprecipitate in the paediatric trauma population. Pilot studies currently under way will go some way to addressing this important knowledge gap, and facilitate the design of larger definitive multi‐centre randomised trials.

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“…First, only two trials have been performed to determine the most effective dosing strategy (e.g., fixed dose vs. weight based vs. targeted to a postinfusion fibrinogen level): an RCT in postpartum hemorrhage found no impact of 2 g of fibrinogen, suggesting the minimum required dose is more than 2 g, and a trial in major pediatric surgery found earlier dosing of fibrinogen concentrate (at a higher FIBTEM maximum clot firmness threshold) was more effective in reducing transfusion requirements . Second, the preemptive use of fibrinogen concentrate before or early in the course of hemorrhage has been tested in only several small pilot trials, and a large definitive trial in severe traumatic hemorrhage is under way with cryoprecipitate (CRYOSTAT‐2/ISRCTN14998314). Overall, the preemptive use of fibrinogen before hemorrhage occurs has not been successful .…”

Section: Fibrinogen Concentratementioning

confidence: 99%

The use of coagulation factor concentrates for perioperative bleeding management – a global perspective

et al. 2020

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KEY IDEAS The use of purified, pathogen‐reduced coagulation factor concentrates instead of a ratio‐driven transfusion protocol using plasma, platelets, or cryoprecipitate may offer a faster, safer, and more specific approach to significantly increase the concentration of coagulation factors in bleeding patients. Available products, on‐label indications, price, and approach to laboratory monitoring differ considerably worldwide. Although evidence regarding optimal thresholds and dose of coagulation factor concentrates to treat massive perioperative bleeding is still limited, recently multiple high‐quality published trials with promising results have been published globally.

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“…Higher quality data from RCT data are scarce – with only three pilot/feasibility studies having been published so far (Curry et al , , ; Nascimento et al , ), and one RCT comparing speed of delivery of fibrinogen concentrate to cryoprecipitate reporting preliminary data at a trauma conference this month (FEISTY, NCT02745041). The three pilot studies evaluated the feasibility of administering (i) CRYOSTAT‐1 (ISRCTN55509212): 4 g fibrinogen (as 2 pools of cryoprecipitate); (ii) FiiRST (NCT02203968): 6 g fibrinogen concentrate and (iii) EFIT‐1 (ISRCTN67540073): 6 g fibrinogen concentrate at timescales of 90, 60 and 45 min.…”

Section: Transfusion and Adjunctive Haemostatic Therapies For Trauma mentioning

confidence: 99%

Transfusion strategies for major haemorrhage in trauma

Curry

Davenport

2018

Br J Haematol

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Summary Trauma is a leading cause of death worldwide in persons under 44 years of age, and uncontrolled haemorrhage is the most common preventable cause of death in this patient group. The transfusion management of trauma haemorrhage is unrecognisable from 20 years ago. Changes in clinical practice have been driven primarily by an increased understanding of the pathophysiology of trauma‐induced coagulopathy (TIC), which is associated with poor clinical outcomes, including a 3‐ to 4‐fold increased risk of death. Targeting this coagulopathy alongside changes to surgical and anaesthetic practices (an overarching strategy known as damage control surgery/damage control resuscitation) has led to a significant reduction in mortality rates over the last two decades. This narrative review will discuss the transfusion practices that are currently used for trauma haemorrhage and the evidence that supports these practices.

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“…Fibrinogen concentrate is made from plasma and, compared with cryoprecipitate, has the advantages of pathogen reduction treatment, small volume of infusion, long shelf‐life, no requirement for thawing before administration and/or need for discard if not transfused within 4–6 h (Nascimento et al, ; McQuilten et al, , ). Nascimento et al .…”

Section: Blood Component and Coagulation Factor Supportmentioning

confidence: 99%

Massive transfusions for critical bleeding: is everything old new again?

2018

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Massive transfusion or major haemorrhage protocols have been widely adopted in the treatment of critically bleeding patients. Following evidence that higher ratios of transfused plasma and platelets to red blood cells may offer survival benefits in military trauma patients, these ratios are now commonly incorporated into massive transfusion protocols. They more closely resemble the effects of whole blood transfusion, which in the second half of last century was largely replaced by individual blood component transfusion based on laboratory-guided indicators. However, high-quality evidence to guide transfusion support for critically bleeding patients across the range of bleeding contexts is lacking, including for both trauma and non-trauma patients. More data on major haemorrhage support and clinical outcomes are needed to inform guidelines and practice.

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Fibrinogen in the initial resuscitation of severe trauma (FiiRST): a randomized feasibility trial

Abstract: Early infusion of FC is feasible and increases plasma fibrinogen concentration during trauma resuscitation. Larger trials are justified.

Cited by 81 publications

References 41 publications

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

Viscoelastic haemostatic assays and fibrinogen in paediatric acute traumatic coagulopathy: A comprehensive review

The use of coagulation factor concentrates for perioperative bleeding management – a global perspective

Transfusion strategies for major haemorrhage in trauma

Massive transfusions for critical bleeding: is everything old new again?

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