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Hemostatic effects of fibrinogen concentrate compared with cryoprecipitate in children after cardiac surgery: A randomized pilot trial
Galas FR, de Almeida JP, Fukushima JT, Vincent JL, Osawa EA, Zeferino S, Camara L, Guimaraes VA, Jatene MB, Hajjar LA
Journal of Thoracic & Cardiovascular Surgery. 2014;148((4):):1647-55.
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Abstract
OBJECTIVES Acute acquired hypofibrinogenemia in children undergoing cardiac surgery is a major concern because it often results in perioperative bleeding and high rates of allogeneic blood transfusion. Fibrinogen concentrate has been proposed as an alternative to cryoprecipitate (the gold standard therapy), with minimal infectious and immunologic risks. Our objective was to investigate the efficacy and safety of fibrinogen concentrate in children undergoing cardiac surgery. METHODS In this randomized pilot study, patients were allocated to receive fibrinogen concentrate (60 mg/kg) or cryoprecipitate (10 mL/kg) if bleeding was associated with fibrinogen levels <1 g/dL after cardiopulmonary bypass weaning. The primary outcome was postoperative blood losses during the 48 hours after surgery. RESULTS A total of 63 patients were included in the study, 30 in the fibrinogen concentrate group and 33 in the cryoprecipitate group. The median 48-hour blood loss was not significantly different between the 2 groups (320 mL [interquartile range, 157-750] vs 410 mL [interquartile range, 215-510], respectively; P = .672). After treatment, plasma fibrinogen concentration increased similarly following administration of both products. There were no differences in allogeneic blood transfusion after intervention treatment. CONCLUSIONS A large trial comparing fibrinogen concentrate and cryoprecipitate in the management of children with acute acquired hypofibrinogenemia during heart surgery is feasible. The preliminary results of our study showed that the use of fibrinogen concentrate was as efficient and safe as cryoprecipitate in the management of bleeding children undergoing cardiac surgery. Copyright 2014 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.
Clinical Commentary
Dr Simon Stanworth - NHS Blood & Transplant, Oxford, UK
What is known?
There are several different sources of fibrinogen for use in patients with major bleeding such as trauma or postpartum or surgery. The two main concentrated sources are fibrinogen concentrate or cryoprecipitate. Cryoprecipitate is the standard method of fibrinogen supplementation in UK. The evidence relating to the clinical effectiveness of cryoprecipitate is very limited; with very few randomised controlled trials (RCTs) completed to date. Fibrinogen concentrate (FgC) is increasingly available and a recent Cochrane review evaluating the effectiveness of FgC for patients with bleeding found limited data (six small trials, none in trauma) but reported no effect on overall mortality but did find a reduction in allogeneic transfusion.
What did this paper set out to examine?
Pilot trials are needed to inform the design of larger definitive trials which can answer fundamental questions about effectiveness of fibrinogen supplementation in patients with major bleeding. This study describes a pilot study of fibrinogen concentrate or cryoprecipitate to reduce bleeding in children undergoing cardiac surgery. Patients younger than 7 years and admitted for elective cardiac surgery and cardio-pulmonary bypass were screened and eligible for randomisation to receive fibrinogen concentrate (60mg/kg) or cryoprecipitate (10ml/kg) if they developed diffuse bleeding at wound surfaces and a fibrinogen concentration < 1g/L/.
What did they show?
A total of 63 patients were included in the pilot, 30 received fibrinogen concentrate and 33 cryoprecipitate. There were no differences in post-operative blood losses (primary outcome), and the median 48 hour blood loss was not significantly different between the two groups. Rises in plasma fibrinogen concentration were similar between the two groups, and there were no significant differences between the groups for adverse events and a range of other clinical outcomes.
What are the implications for practice and for future work?
In addition to documenting feasibility of recruitment, the pilot study supports the need for larger trials, not just to understand how different sources of fibrinogen should be used, but also to evaluate comparative differences between products. Cryoprecipitate is a pooled blood component) that has a variable, but high Fg concentration (15-20 g/L), but also contains other plasma proteins (FVIII, FXIII, von Willebrand’s factor and fibronectin) which may confer additional haemostatic benefits.