Randomized evaluation of fibrinogen vs placebo in complex cardiovascular surgery (REPLACE): a double-blind phase III study of haemostatic therapy

Rahe‐Meyer, Niels; Levy, Jerrold H.; Mazer, C. David; Schramko, Alexey; Klein, A. A.; Brát, Radim; Okita, Yutaka; Ueda, Yuichi; Schmidt, Daniel; Ranganath, Ramakrishnan; Gill, Ravi

doi:10.1093/bja/aew169

Cited by 115 publications

(138 citation statements)

References 23 publications

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“…However, the data presented showed that the mean plasma fibrinogen level in both groups was > 4g/l and therefore hypofibrinogenaemia was unlikely to be contributing to bleeding. The REPLACE study; investigating FC use in cardiac surgery has recently been published (158). This study randomised patients to FC or Placebo with a 5 minute bleeding mass of >60g after separation from cardio-pulmonary bypass.…”

Section: Fibrinogen Trials In Non-traumatic Haemorrhagementioning

confidence: 99%

“…The results of FEISTY will be used to design a larger and hopefully definitive multi-centre study with the aim of addressing patient centred outcomes such as allogenic blood product transfusion requirements and mortality. By performing a pilot multi-centre study it is hoped to identify logistical issues that could impact on the design and conduct of a definitive study and potentially avoid the mistakes made in recently published FC studies (158).…”

Section: Fibrinogen Trials In Traumatic Haemorrhagementioning

confidence: 99%

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Fibrinogen in traumatic haemorrhage: A narrative review

Winearls

Campbell

Hurn

et al. 2017

Injury

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Abstract:Haemorrhage in the setting of severe trauma is associated with significant morbidity and mortality. There is increasing awareness of the important role fibrinogen plays in traumatic haemorrhage. Fibrinogen levels fall precipitously in severe trauma and the resultant hypofibrinogenaemia is associated with poor outcomes. Hence, it has been postulated that early fibrinogen replacement in severe traumatic haemorrhage may improve outcomes, although, to date there is a paucity of high quality evidence to support this hypothesis. In addition there is controversy regarding the optimal method for fibrinogen supplementation. We review the current evidence regarding the role of fibrinogen in trauma, the rationale behind fibrinogen supplementation and discuss current research.

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Section: Fibrinogen Trials In Non-traumatic Haemorrhagementioning

confidence: 99%

Section: Fibrinogen Trials In Traumatic Haemorrhagementioning

confidence: 99%

Fibrinogen in traumatic haemorrhage: A narrative review

Winearls

Campbell

Hurn

et al. 2017

Injury

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“…37 These results and others from previous RCTs of fibrinogen concentrate in surgery summarized by Levy et al 38 do not highlight any thrombotic or safety concerns with fibrinogen concentrate. Further safety and adverse event data should become available for cryoprecipitate and fibrinogen concentrate with increased clinical experience and trials of fibrinogen replacement in active hemorrhage.…”

Section: Thrombotic Complicationsmentioning

confidence: 55%

Cryoprecipitate transfusion: current perspectives

Wong¹,

Curry²

2016

IJCTM

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“…Our original study design had to be modified because of a very slow recruitment rate due to screening failures. Despite having a simpler bleeding assessment compared with other fibrinogen studies, we encountered no diffuse bleeding after 44 patients . In addition, we changed the inclusion criteria to only patients with lower pre‐operative fibrinogen levels.…”

Section: Discussionmentioning

confidence: 99%

“…Several studies have provided evidence supporting its superiority to conventional treatment using FFP and a recently published trial (FIBRES) demonstrated non‐inferiority of fibrinogen concentrate compared with Cryo usage in severe bleeding . Other studies have shown conflicting results . Results from single‐center studies with different designs (prophylactic approach or bleeding assessment) could not be confirmed by an international multicenter trial (REPLACE) .…”

Section: Introductionmentioning

confidence: 99%

The prophylactic use of fibrinogen concentrate in high‐risk cardiac surgery

Kwapisz

Kent

DiQuinzio

et al. 2020

Acta Anaesthesiol Scand

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Background Perioperative blood loss is a major contributor to morbidity and mortality in cardiac surgery. Plasma fibrinogen levels play an essential role in hemostasis and deplete quickly during hemorrhage. The objective of this study was to determine whether prophylactic fibrinogen concentrate administration lowers overall blood product transfusion requirements in high‐risk cardiac surgery in patients with low fibrinogen plasma levels. Methods The study was performed in a prospective, randomized, and double‐blinded design. The investigation included 62 patients undergoing elective, high‐risk cardiac surgery. After weaning from cardiopulmonary bypass and reversal of heparin patients received either fibrinogen concentrate or placebo. The primary outcome variable was overall blood product usage 24 hours after intervention. Results The fibrinogen group received numerically fewer total units of blood products than the placebo group, but the difference was not statistically or clinically significant (for groups n = 27; n = 29 and 19 vs 37 units, respectively, P = .908). The overall transfusion rate in both groups was significantly lower than the institutional average suggested (fibrinogen group 26%, placebo group 28%). The fibrinogen group showed significantly higher fibrinogen levels (2.38 vs 1.83 g/L (end of surgery), P < .001; 3.33 vs 2.68 g/L (12 hours after intervention), P = .003) and improved viscoelastic coagulation parameters (FIBTEM MCF, 27 vs 23 mm, P = .022). Conclusion This randomized, controlled trial demonstrates that point‐of‐care guided and prophylactic treatment with fibrinogen concentrate does not reduce transfusion of blood products in a setting of unexpectedly low transfusion rate as tested in this cohort, but may improve coagulation parameters in the setting of high‐risk cardiac surgery.

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Randomized evaluation of fibrinogen vs placebo in complex cardiovascular surgery (REPLACE): a double-blind phase III study of haemostatic therapy

Abstract: ClinicalTrials.gov identifier no. NCT01475669; EudraCT trial no. 2011-002685-20.

Cited by 115 publications

References 23 publications

Fibrinogen in traumatic haemorrhage: A narrative review

Fibrinogen in traumatic haemorrhage: A narrative review

Cryoprecipitate transfusion: current perspectives

The prophylactic use of fibrinogen concentrate in high‐risk cardiac surgery

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