1.
Use of fibrinogen concentrate for trauma-related bleeding: A systematic-review and meta-analysis
Stabler, S. N., Li, S. S., Karpov, A., Vu, E. N.
The Journal of Trauma and Acute Care Surgery. 2020;89(6):1212-1224
Abstract
BACKGROUND Trauma-induced coagulopathy contributes to significant morbidity and mortality in patients who experience trauma-related bleeding. This study aimed to synthesize the evidence supporting the efficacy and safety of preemptive and goal-directed fibrinogen concentrate (FC) in the management of trauma-related hemorrhage. METHODS PubMed, Medline, EMBASE, Web of Science, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, ClinicalTrials.gov, and the WHO International Clinical Trials Registry Platform were systematically searched. All trial designs, except individual case reports, which evaluated the preemptive or goal-directed use of FC for trauma-related bleeding/coagulopathy, in patients older than 16 years, were included in the systematic review. For the included randomized controlled trials comparing FC with control, meta-analysis was performed and a risk-of bias-assessment was completed using the Cochrane Methodology and Preferred Reporting Items Systematic Reviews and Meta-analysis guidelines. RESULTS A total of 2,743 studies were identified; 26 were included in the systematic review, and 5 randomized controlled trials (n = 238) were included in the meta-analysis. For the primary outcome of mortality, there was no statistically significant difference between the groups, with 22% and 23.4% in the FC and comparator arms, respectively (risk ratio, 1.00 [95% confidence interval, 0.39 to 2.56]; p = 0.99). In addition, there was no statistical difference between FC and control in packed red blood cell, fresh frozen plasma, or platelet transfusion requirements, and thromboembolic events. Overall, the quality of evidence was graded as low to moderate because of concerns with risk of bias, imprecision, and inconsistency. CONCLUSION Further high-quality, adequately powered studies are needed to assess the impact of FC in trauma, with a focus on administration as early as possible from the point of entry into the trauma system of care. LEVEL OF EVIDENCE Systematic review and Meta-analysis, level II.
2.
The use of fibrinogen concentrate for the management of trauma-related bleeding: a systematic review and meta-analysis
Mengoli C, Franchini M, Marano G, Pupella S, Vaglio S, MariettaM, Liumbruno GM
Blood Transfusion.. 2017;15((4)):318-324.
Abstract
Haemorrhage following injury is associated with significant morbidity and mortality. The role of fibrinogen concentrate in trauma-induced coagulopathy has been the object of intense research in the last 10 years and has been systematically analysed in this review. A systematic search of the literature identified six retrospective studies and one prospective one, involving 1,650 trauma patients. There were no randomised trials. Meta-analysis showed that fibrinogen concentrate has no effect on overall mortality (risk ratio: 1.07, 95% confidence interval: 0.83-1.38). Although the meta-analytic pooling of the current literature evidence suggests no beneficial effect of fibrinogen concentrate in the setting of severe trauma, the quality of data retrieved was poor and the final results of ongoing randomised trials will help to further elucidate the role of fibrinogen concentrate in traumatic bleeding.
3.
Efficacy and safety of fibrinogen concentrate in trauma patients--a systematic review
Aubron C, Reade MC, Fraser JF, Cooper DJ
Journal of Critical Care. 2014;29((3):):471.e11-7.
Abstract
PURPOSE Uncontrolled bleeding is the main preventable cause of death in severe trauma patients. Fibrinogen is the first coagulation factor to decrease during trauma-induced coagulopathy, suggesting that pharmacological replacement might assist early hemorrhage control. Several sources of fibrinogen are available; however, fibrinogen concentrate (FC) is not routinely used in trauma settings in most countries. The aim of this review is to summarize the available literature evaluating the use of FC in the management of severe trauma. METHODS Studies reporting the administration of FC in trauma patients published between January 2000 and April 2013 were identified from MEDLINE and from the Cochrane Library. RESULTS The systematic review identified 12 articles reporting FC usage in trauma patients: 4 case reports, 7 retrospective studies, and 1 prospective observational study. Three of these were not restricted to trauma patients. CONCLUSIONS Despite methodological flaws, some of the available studies suggested that FC administration may be associated with a reduced blood product requirement. Randomized trials are warranted to determine whether FC improves outcomes in prehospital management of trauma patients or whether FC is superior to another source of fibrinogen in early hospital management of trauma patients. Copyright 2014 Elsevier Inc. All rights reserved.
4.
Fibrinogen concentrates for bleeding trauma patients: what is the evidence?
Meyer MA, Ostrowski SR, Windelov NA, Johansson PI
Vox Sanguinis. 2011;101((3):):185-90.
Abstract
Introduction: A balanced transfusion of red blood cells, fresh frozen plasma and platelets are recommended for massively bleeding trauma patients. Fibrinogen concentrates could potentially lessen or replace the need for fresh frozen plasma and/or platelet transfusions. Objective: To provide a review of the literature covering the application of fibrinogen concentrates in trauma care. Methods: PubMed and Cochrane database search, 'fibrinogen' and ('concentrate' or 'trauma'), not 'congenital', 10[em space]years. Results: Only four papers were identified. None were randomized controlled trials. The main conclusion of these papers was that administration of fibrinogen sometimes together with prothrombin complex concentrate might improve haemostasis in trauma patients resuscitated with synthetic colloids. Conclusion: Evidence for the use of fibrinogen concentrate to trauma patients with massive bleeding is lacking. Well-designed prospective, randomized, double-blinded studies evaluating the effect of fibrinogen concentrate, as the only intervention, are urgently needed. Copyright 2011 The Author(s). Vox Sanguinis Copyright 2011 International Society of Blood Transfusion.
5.
A systematic review of randomized controlled trials exploring the effect of immunomodulative interventions on infection, organ failure, and mortality in trauma patients
Spruijt NE, Visser T, Leenen LP
Critical Care (London, England). 2010;14((4):):R150.
Abstract
INTRODUCTION Following trauma, patients may suffer an overwhelming pro-inflammatory response and immune paralysis resulting in infection and multiple organ failure (MOF). Various potentially immunomodulative interventions have been tested. The objective of this study is to systematically review the randomized controlled trials (RCTs) that investigate the effect of potentially immunomodulative interventions in comparison to a placebo or standard therapy on infection, MOF, and mortality in trauma patients. METHODS A computerized search of MEDLINE, the Cochrane CENTRAL Register of Controlled Trials, and EMBASE yielded 502 studies, of which 18 unique RCTs were deemed relevant for this study. The methodological quality of these RCTs was assessed using a critical appraisal checklist for therapy articles from the Centre for Evidence Based Medicine. The effects of the test interventions on infection, MOF, and mortality rates and inflammatory parameters relative to the controls were recorded. RESULTS In most studies, the inflammatory parameters differed significantly between the test and control groups. However, significant changes in infection, MOF, and mortality rates were only measured in studies testing immunoglobulin, IFN-, and glucan. CONCLUSIONS Based on level 1b and 2b studies, administration of immunoglobulin, IFN-, or glucan have shown the most promising results to improve the outcome of trauma patients.