1.
Emergency administration of fibrinogen concentrate for haemorrhage: systematic review and meta-analysis
Itagaki Y, Hayakawa M, Takahashi Y, Hirano S, Yamakawa K
World journal of emergency surgery : WJES. 2023;18(1):27
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Abstract
INTRODUCTION The occurrence of massive haemorrhages in various emergency situations increases the need for blood transfusions and increases the risk of mortality. Fibrinogen concentrate (FC) use may increase plasma fibrinogen levels more rapidly than fresh-frozen product or cryoprecipitate use. Previous several systematic reviews and meta-analyses have not effectively demonstrated FC efficacy in significantly improving the risk of mortality and reducing transfusion requirements. In this study, we investigated the use of FC for haemorrhages in emergency situations. METHODS AND ANALYSIS In this systematic review and meta-analysis, we included controlled trials, but excluded randomized controlled trials (RCTs) in elective surgeries. The study population consisted of patients with haemorrhages in emergency situations, and the intervention was emergency supplementation of FC. The control group was administered with ordinal transfusion or placebo. The primary and secondary outcomes were in-hospital mortality and the amount of transfusion and thrombotic events, respectively. The electronic databases searched included MEDLINE (PubMed), Web of Science, and the Cochrane Central Register of Controlled Trials. RESULTS Nine RCTs in the qualitative synthesis with a total of 701 patients were included. Results showed a slight increase in in-hospital mortality with FC treatment (RR 1.24, 95% CI 0.64-2.39, p = 0.52) with very low certainty of the evidence. There was no reduction in the use of red blood cells (RBC) transfusion in the first 24 h after admission with FC treatment (mean difference [MD] 0.0 Unit in the FC group, 95% CI - 0.99-0.98, p = 0.99) with very low certainty of the evidence. However, the use of fresh-frozen plasma (FFP) transfusion significantly increased in the first 24 h after admission with FC treatment (MD 2.61 Unit higher in the FC group, 95% CI 0.07-5.16, p = 0.04). The occurrence of thrombotic events did not significantly differ with FC treatment. CONCLUSIONS The present study indicates that the use of FC may result in a slight increase in in-hospital mortality. While FC did not appear to reduce the use of RBC transfusion, it likely increased the use of FFP transfusion and may result in a large increase in platelet concentrate transfusion. However, the results should be interpreted cautiously due to the unbalanced severity in the patient population, high heterogeneity, and risk of bias.
PICO Summary
Population
Patients admitted to hospital with emergency haemorrhage (9 randomised controlled trials, n= 701).
Intervention
Emergency supplementation of fibrinogen concentrate (FC).
Comparison
Standard transfusion treatments or placebo.
Outcome
Results showed a slight increase in in-hospital mortality with FC treatment (RR 1.24; 95% CI [0.64, 2.39]) with very low certainty of the evidence. There was no reduction in the use of red blood cells transfusion in the first 24 h after admission with FC treatment (mean difference [MD] 0.0 Unit in the FC group, 95% CI [- 0.99, 0.98]) with very low certainty of the evidence. The use of fresh-frozen plasma transfusion significantly increased in the first 24 h after admission with FC treatment (MD 2.61 Unit higher in the FC group, 95% CI [0.07, 5.16]). The occurrence of thrombotic events did not significantly differ with FC treatment.
2.
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.
3.
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.
4.
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.