Use Of Fibrinogen Research Articles

Human Fibrinogen for Maintenance and Differentiation of Induced Pluripotent Stem Cells in Two Dimensions and Three Dimensions.

Human fibrin hydrogels are a popular choice for use as a biomaterial within tissue engineered constructs because they are biocompatible, nonxenogenic, autologous use compatible, and biodegradable. We have recently demonstrated the ability to culture induced pluripotent stem cell (iPSC)‐derived retinal pigment epithelium on fibrin hydrogels. However, iPSCs themselves have relatively few substrate options (e.g., laminin) for expansion in adherent cell culture for use in cell therapy. To address this, we investigated the potential of culturing iPSCs on fibrin hydrogels for three‐dimensional applications and further examined the use of fibrinogen, the soluble precursor protein, as a coating substrate for traditional adherent cell culture. iPSCs successfully adhered to and proliferated on fibrin hydrogels. The two‐dimensional culture with fibrinogen allows for immediate adaption of culture models to a nonxenogeneic model. Similarly, multiple commercially available iPSC lines adhered to and proliferated on fibrinogen coated surfaces. iPSCs cultured on fibrinogen expressed similar levels of the pluripotent stem cell markers SSea4 (98.7% ± 1.8%), Oct3/4 (97.3% ± 3.8%), TRA1‐60 (92.2% ± 5.3%), and NANOG (96.0% ± 3.9%) compared with iPSCs on Geltrex. Using a trilineage differentiation assay, we found no difference in the ability of iPSCs grown on fibrinogen or Geltrex to differentiate to endoderm, mesoderm, or ectoderm. Finally, we demonstrated the ability to differentiate iPSCs to endothelial cells using only fibrinogen coated plates. On the basis of these data, we conclude that human fibrinogen provides a readily available and inexpensive alternative to laminin‐based products for the growth, expansion, and differentiation of iPSCs for use in research and clinical cell therapy applications. stem cells translational medicine 2019;8:512–521

Patient blood management in cardiac surgery: The “Granducato algorithm”

BackgroundPatients undergoing cardiac surgery are subject to severe alterations of the coagulation system. The four cardiac surgery centers in Tuscany (Italy) structured and shared an algorithm (Granducato Patient Blood Management algorithm, G-PBMa) with predefined interventions for patient blood management. The aim of the study is to analyze the impact of that algorithm on the transfusion needs and bleeding-related outcomes in a large patient population. MethodsMulticenter retrospective observational study on 3839 patients undergoing cardiac surgery at the four cardiac centers in Tuscany. The G-PBMa was released at the end of 2015 and it was structured in three parts: pre-, intra-, and post-operative. The year 2014, before the G-PBMa (1955 patients) and the year 2016 (1884 patients) after the G-PBMa in place were compared. Logistic regression analyses were used. ResultsThe main changes introduced were the routine application of viscoelastic tests in bleeding patients (+72%) and the use of fibrinogen and prothrombin complex concentrate (+67%). The G-PBMa resulted in a significant reduction in the overall transfusion rate and in the transfusion rate of the separate blood products (relative risk for transfusions: 0.75, 95% confidence interval 0.65–0.85, P = 0.001). For preoperative hemoglobin values of between 8 and 10 g/dL, the absolute difference in RBC transfusion rate before and after the G-PBMa introduction ranged around 15%–17%. The G-PBMa introduction determined lower (P = 0.02) chest drain blood loss, lower (P = 0.001) postoperative acute kidney injury and shorter (P = 0.001) hospital stay. ConclusionsThe G-PBMa was effective in reducing blood loss, transfusion requirements, and resulted in a better outcome.

Blood fibrinogen levels discriminate low- and high risk intraductal papillary mucinous neoplasms (IPMNs)

Background: The risk assessment of intraductal papillary mucinous neoplasms (IPMN) to either guide patients to surgical resection or watchful waiting is still under debate. Additional markers to better separate low and high-risk lesions would improve patient selection. Methods: Patients who underwent pancreatic resections for IPMNs between January 2008 and December 2012 with available blood samples were selected and retrospectively assessed. Data on cyst characteristics such as cyst size, duct relation and main-duct dilatation were collected and plasma fibrinogen levels were measured. Results: A total of 73 patients fulfilled the inclusion criteria by pancreatic resection for pathologically confirmed IPMN and available blood sample. Histologically, IPMNs were classified as low-grade and borderline in 52 (71.2%, group 1) and as high-grade and invasive in 21 (28.8%, group 2) of all cases. Fibrinogen levels showed significant differences between the two groups (group 1: mean 3.62 g/L (SD ± 1.14); group 2: mean 4.49 g/L (SD ± 1.57); p= 0.027). A ROC-curve analysis calculated a cut-off value of 4.71 g/L separated groups 1 and 2 (p= 0.008). Fibrinogen levels remained as the only significant factor in multivariable analysis, cyst size and duct relation were not significant. Conclusion: Blood fibrinogen differed between low and high risk IPMNs and therefore, the use of fibrinogen as an additional discriminator in the pre-operative risk assessment of IPMNs should be further evaluated.

Blood fibrinogen levels discriminate low- and high risk intraductal papillary mucinous neoplasms (IPMNs)

Background: The risk assessment of intraductal papillary mucinous neoplasms (IPMN) to either guide patients to surgical resection or watchful waiting is still under debate. Additional markers to better separate low and high-risk lesions would improve patient selection. Methods: Patients who underwent pancreatic resections for IPMNs between January 2008 and December 2012 with available blood samples were selected and retrospectively assessed. Data on cyst characteristics such as cyst size, duct relation and main-duct dilatation were collected and plasma fibrinogen levels were measured. Results: A total of 73 patients fulfilled the inclusion criteria by pancreatic resection for pathologically confirmed IPMN and available blood sample. Histologically, IPMNs were classified as low-grade and borderline in 52 (71.2%, group 1) and as high-grade and invasive in 21 (28.8%, group 2) of all cases. Fibrinogen levels showed significant differences between the two groups (group 1: mean 3.62 g/L (SD ± 1.14); group 2: mean 4.49 g/L (SD ± 1.57); p= 0.027). A ROC-curve analysis calculated a cut-off value of 4.71 g/L separated groups 1 and 2 (p= 0.008). Fibrinogen levels remained as the only significant factor in multivariable analysis, cyst size and duct relation were not significant. Conclusion: Blood fibrinogen differed between low and high risk IPMNs and therefore, the use of fibrinogen as an additional discriminator in the pre-operative risk assessment of IPMNs should be further evaluated.

Pro-coagulant haemostatic factors for the prevention and treatment of bleeding in people without haemophilia.

Pro-coagulant haemostatic factors for the prevention and treatment of bleeding in people without haemophilia.

Early fibrinogen concentrate therapy for major haemorrhage in trauma (E-FIT 1): results from a UK multi-centre, randomised, double blind, placebo-controlled pilot trial

BackgroundThere is increasing interest in the timely administration of concentrated sources of fibrinogen to patients with major traumatic bleeding. Following evaluation of early cryoprecipitate in the CRYOSTAT 1 trial, we explored the use of fibrinogen concentrate, which may have advantages of more rapid administration in acute haemorrhage. The aims of this pragmatic study were to assess the feasibility of fibrinogen concentrate administration within 45 minutes of hospital admission and to quantify efficacy in maintaining fibrinogen levels ≥ 2 g/L during active haemorrhage.MethodsWe conducted a blinded, randomised, placebo-controlled trial at five UK major trauma centres with adult trauma patients with active bleeding who required activation of the major haemorrhage protocol. Participants were randomised to standard major haemorrhage therapy plus 6 g of fibrinogen concentrate or placebo.ResultsTwenty-seven of 39 participants (69%; 95% CI, 52–83%) across both arms received the study intervention within 45 minutes of admission. There was some evidence of a difference in the proportion of participants with fibrinogen levels ≥ 2 g/L between arms (p = 0.10). Fibrinogen levels in the fibrinogen concentrate (FgC) arm rose by a mean of 0.9 g/L (SD, 0.5) compared with a reduction of 0.2 g/L (SD, 0.5) in the placebo arm and were significantly higher in the FgC arm (p < 0.0001) at 2 hours. Fibrinogen levels were not different at day 7. Transfusion use and thromboembolic events were similar between arms. All-cause mortality at 28 days was 35.5% (95% CI, 23.8–50.8%) overall, with no difference between arms.ConclusionsIn this trial, early delivery of fibrinogen concentrate within 45 minutes of admission was not feasible. Although evidence points to a key role for fibrinogen in the treatment of major bleeding, researchers need to recognise the challenges of timely delivery in the emergency setting. Future studies must explore barriers to rapid fibrinogen therapy, focusing on methods to reduce time to randomisation, using ‘off-the-shelf’ fibrinogen therapies (such as extended shelf-life cryoprecipitate held in the emergency department or fibrinogen concentrates with very rapid reconstitution times) and limiting the need for coagulation test-based transfusion triggers.Trial registrationISRCTN67540073. Registered on 5 August 2015.

Evaluation of the Safety of Fibrinogen Concentrate Administration for Bleeding Control in Neurosurgery

Background and Objective: Bleeding control is extremely important in any surgical procedure, especially in neurological surgery. Hemodilution with colloid and crystalloid may predispose to functional impairment of fibrinogen, which replacement may be beneficial. We evaluated the safety of fibrinogen concentrate administration in patients who underwent a neurosurgical procedure. Method: We reviewed the medical charts of a series of consecutive patients who received prophylactic fibrinogen concentrate and underwent a neurosurgical procedure for different pathologies in our institution from July 2009 to July 2010. Adverse effects, red blood cells and platelet transfusions were carefully recorded in all cases. Results: Twelve patients were included in our study. There were seven (58%) men and five (42%) women, with a median age of 37 years. All patients had a normal baseline laboratory tests. There was no case of allergic reactions or any adverse events related to fibrinogen administration. None of them required red blood cells or platelet transfusions after surgery, and there were no thrombotic events during 30 days of follow-up. Conclusion: The prophylactic use of fibrinogen concentrate appears to be safe in neurosurgery and may reduce the need of blood derivatives transfusion. Additional prospective studies should be performed to assess the efficacy of this strategy.

European Guidelines on perioperative venous thromboembolism prophylaxis: Executive summary.

European Guidelines on perioperative venous thromboembolism prophylaxis: Executive summary.

Programa de ahorro de sangre en cirugía cardiaca: resultados

ObjectiveThe main objective of the study was to evaluate the effect of implementing a blood-saving programme in patients undergoing elective cardiac surgery with an analysis of the transfusion rate and complications. Materials and methodsA single-centre, observational, retrospective, comparative study which included 604 consecutive patients older than 15 years old undergoing elective cardiac surgery. Two groups of patients were created according to whether or not they were included in a blood-saving protocol, and analysed between December 2012 and July 2013 (293 patients, prep group) and April 2015 to May 2016 (311 patients, posp group). ResultsThe overall blood product transfusion rate was reduced in the posp group (89.5 vs. 67.6%; P<0.001), as well as individually: red blood cell concentrates (83.6%; P<0.001), fresh frozen plasma (36.2 vs. 21.2%; P<0.001), platelets (40.8 vs. 32.7; P<0.001). By contrast, fibrinogen use increased from 16.4 to 49% (P<0.001). Postoperative complications were similar in both groups, except for pulmonary complications (57.8 vs. 43.1%; P<0.001). Length of hospital stay was similar in both groups except in the Critical Care Unit with longer stay for the prep group (5.81±8.00 vs. 4.18±4.38; P=0.002). Mortality did not change. ConclusionsThe implementation of a blood-saving programme in the cardiac surgery area has favourable consequences, such as a saving in blood product and a reduction of pulmonary complications, although without decreasing the mortality rate.

Анализ влияния транексамовой кислоты, фактора XIII и концентрата фибриногена на формирование и лизис кровяного сгустка при избыточном фибринолизе, индуцированном тканевым и урокиназным активатором плазминогена

Aim of the study. To compare the effects of tranexamic acid (TXA), factor XIII concentrate (FXIII) and fibrinogen concentrate on clot formation and fibrinolytic resistance in the in vitro model of hyperfibrinolysis induced by tissue- (tPA) vs urokinase-type (uPA) plasminogen activators. Materials and methods. Citrated whole blood from 28 adult healthy volunteers was supplemented with 10 μg/ mL TXA, 2 IU/mL FXIII, or 3 mg/mL fibrinogen concentrate. Hyperfibrinolysis was induced by spiking the blood with tPA or uPA at their half-maximal effective concentrations (90 and 33 IU/mL, respectively). Clotting was induced by recalcification and addition of tissue factor and monitored using rotation thromboelastometry. Results. The use of TXA increased maximal clot firmness in the presence of tPA and markedly inhibited clot lysis in the presence of any of the plasminogen activators. Supplementation of blood with FXIII significantly increased clot firmness and improved fibrinolytic resistance in the presence of either tPA or uPA. Supplementation with fibrinogen concentrate elicited a strikingly different effect on clot formation and lysis depending on the type of plasminogen activator. In the presence of tPA, fibrinogen concentrate significantly increased clot firmness and attenuated clot lysis. In contrast, in the presence of uPA, the use of fibrinogen markedly reduced clot firmness and promoted clot lysis. Similar effects of fibrinogen concentrate were observed in platelet-rich and microparticles-free plasma. Conclusion. In hyperfibrinolysis, effect of the hemostatic drugs significantly depends on the type of plasminogen activator used. Therefore, mechanisms of hyperfibrinolysis should be taken into consideration while administering hemostatic drugs.

Fibrinogen Concentrate in the Special Operations Forces Environment.

Hemorrhage is the most common cause of death among Special Operations Force (SOF) soldiers. Bringing remote damage control resuscitation into the far-forward combat environment is logistically challenging, as it requires blood products that generally require a robust cold chain. Alternatively, lyophilized products such as fibrinogen concentrate, which does not require thawing or blood group compatibility testing before use, might be advantageous in damage control resuscitation in the battlefield. In this report, we review the evidence for the use of fibrinogen concentrate in the Canadian SOF environment. The literature on the use of fibrinogen concentrate in the trauma setting was reviewed by Canadian Forces Services Working Group, in three separate meetings. Multiple stakeholders were consulted to obtain authoritative perspectives from subject matter experts on the use of fibrinogen concentrate in the Canadian SOF environment. We also conducted a comparison review of fibrinogen content, pathogen risk, shelf life, and methods required for use for fresh frozen plasma, cryoprecipitate, and fibrinogen concentrate relevant to their application in the far-forward combat environment. Indications and a protocol for the use of fibrinogen as an adjunct to fresh whole blood were formulated based on a literature review and clinical expert opinion. Alternative strategies and other lyophilized blood products were considered before selecting fibrinogen concentrate as the lyophilized blood product of choice. Fibrinogen concentrate is an ABO-universal blood product with an excellent safety profile. Training was conducted by subject matter experts within civilian trauma centers and at military training facilities. The clinical efficacy and safety were confirmed by monitoring the use of fibrinogen concentrate in deployed combat settings. Fibrinogen concentrate is a useful adjunct to remote damage control resuscitation in the SOF environment. Fibrinogen concentrate was found to be robust for transport into the SOF environment and is widely accepted among SOF operators and medics.

Biomaterials and Advanced Technologies for Hemostatic Management of Bleeding.

Bleeding complications arising from trauma, surgery, and as congenital, disease-associated, or drug-induced blood disorders can cause significant morbidities and mortalities in civilian and military populations. Therefore, stoppage of bleeding (hemostasis) is of paramount clinical significance in prophylactic, surgical, and emergency scenarios. For externally accessible injuries, a variety of natural and synthetic biomaterials have undergone robust research, leading to hemostatic technologies including glues, bandages, tamponades, tourniquets, dressings, and procoagulant powders. In contrast, treatment of internal noncompressible hemorrhage still heavily depends on transfusion of whole blood or blood's hemostatic components (platelets, fibrinogen, and coagulation factors). Transfusion of platelets poses significant challenges of limited availability, high cost, contamination risks, short shelf-life, low portability, performance variability, and immunological side effects, while use of fibrinogen or coagulation factors provides only partial mechanisms for hemostasis. With such considerations, significant interdisciplinary research endeavors have been focused on developing materials and technologies that can be manufactured conveniently, sterilized to minimize contamination and enhance shelf-life, and administered intravenously to mimic, leverage, and amplify physiological hemostatic mechanisms. Here, a comprehensive review regarding the various topical, intracavitary, and intravenous hemostatic technologies in terms of materials, mechanisms, and state-of-art is provided, and challenges and opportunities to help advancement of the field are discussed.

Use of fibrinogen and thrombin sponge in pediatric split liver transplantation.

To analyze the use of this sponge in pediatric patients undergoing split-liver transplantation. Retrospective study, including 35 pediatric patients undergoing split-liver transplantation, divided into two groups according to the use of the sponge: 18 patients in Group A (no sponge) and 17 in Group B (with sponge). The characteristics of recipients and donors were similar. We observed greater number of reoperation due to bleeding in the wound area in Group A (10 patients - 55.5%) than in Group B (3 patients - 17.6%); p = 0.035. The median volume of red blood cells transfused in Group A was significantly higher (73.4 ± 102.38 mL/kg) than that in Group B (35.1 ± 41.67 mL/kg); p = 0.048. Regarding bile leak there was no statistical difference. The use of the human fibrinogen and thrombin sponge, required lower volume of red blood cell transfusion and presented lower reoperation rates due to bleeding in the wound area.

The use of fibrinogen concentrate for the management of trauma-related bleeding: a systematic review and meta-analysis.

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.

Fibrinogen and postpartum hemorrhage – Association or causality?

Postpartum hemorrhage (PPH) is the leading cause of maternal death worldwide, accounting for one in four maternal deaths. Despite efforts in public health policy, the incidence of massive PPH has increased in recent years even in first world countries. In Colombia, PPH is the second leading cause of maternal death. Multiple observational studies have provided evidence about the association between the concentration levels of fibrinogen in blood plasma and the severity of PPH, proposing the systematic use of fibrinogen concentrates as a prophylactic or therapeutic measure in patients with obstetric hemorrhage. However, the statistical relationship demonstrated in such studies should not necessarily be interpreted as a cause-effect relationship. Traditionally, we have used the criteria postulated by Sir Arthur Bradford Hill to establish a causal relationship. Therefore, the most pragmatic way to evaluate a possible causal relationship is through a randomized placebo-controlled experiment. Experiments of this kind available to date have methodological deficiencies or have been criticized for internal validity. As a result, the statistical relationship (association) between low levels of fibrinogen and PPH cannot be certainly interpreted as a cause-effect relationship and the use of fibrinogen concentrates may only be justified in the context of new clinical trials.

Fibrinógeno y hemorragia posparto. ¿Asociación o causalidad?

Postpartum hemorrhage (PPH) is the leading cause of maternal death worldwide, accounting for one in four maternal deaths. Despite efforts in public health policy, the incidence of massive PPH has increased in recent years even in first world countries. In Colombia, PPH is the second leading cause of maternal death. Multiple observational studies have provided evidence about the association between the concentration levels of fibrinogen in blood plasma and the severity of PPH, proposing the systematic use of fibrinogen concentrates as a prophylactic or therapeutic measure in patients with obstetric hemorrhage. However, the statistical relationship demonstrated in such studies should not necessarily be interpreted as a cause-effect relationship. Traditionally, we have used the criteria postulated by Sir Arthur Bradford Hill to establish a causal relationship. Therefore, the most pragmatic way to evaluate a possible causal relationship is through a randomized placebo-controlled experiment. Experiments of this kind available to date have methodological deficiencies or have been criticized for internal validity. As a result, the statistical relationship (association) between low levels of fibrinogen and PPH cannot be certainly interpreted as a cause-effect relationship and the use of fibrinogen concentrates may only be justified in the context of new clinical trials.

Fibrinogen Supplementation Ex Vivo Increases Clot Firmness Comparable to Platelet Transfusion in Thrombocytopenia

(Abstracted from Br J Anaesth, 117(5):576–582, 2016) This study investigates how the use of fibrinogen concentrate ex vivo compares to the use of in vivo platelet transfusion (PT) to improve clot firmness in patients with thrombocytopenia (platelet count <150 × 109 L−1). While PT is currently first-line treatment to prevent bleeding in patients with clinically significant thrombocytopenia, PT carries significant risks, including viral or bacterial infection, febrile and nonfebrile transfusion reactions, and transfusion-related lung injury.

Abstract 031: Determination of Drivers of Cost Variation in Aortic Valve Replacement; a Case Costing Approach

Objective: We sought to establish the cost of an aortic valve replacement (AVR) in a single, tertiary cardiac centre through a detailed case costing approach, and to identify the cost drivers of AVR. Methods: Intra-operative consumables were collected directly from the operating room during the procedure while indirect costs were calculated after the procedure had been finished using time based calculations and straight line depreciation. Costs were divided into four departments: Pharmacy costs, including all drugs and fibrinogen, Perfusion costs, including all required blood products and cardiopulmonary bypass consumables excluding cannulas, Cardiac Surgery costs, including valves, cannulas and catheters opened for each case, and Anesthesia costs, including rotational thromboelastometry (ROTEM) test, central monitoring cannulas, endotracheal tubes and monitoring disposables. Results: We were able to calculate costs for 24 patients undergoing isolated AVR between June and August, 2016.. The average intra-operating room per-patient costs were $8,629.70 with a standard deviation of $1,623.74. Backwards-stepwise linear regression showed that perfusion (beta coefficient 0.332; p = 0.002), pharmacy (beta coefficient 0.425; p &lt; 0.001) and cardiac surgery (beta coefficient 0.587; p &lt; 0.001) were all significant sources of cost variability between cases. In Pharmacy, the largest driver of cost was the use of fibrinogen. In Perfusion, the largest driver of cost was blood product use. . In Cardiac Surgery, the largest driver of cost was the selection of prosthesis by the surgeon. Although anesthesia costs did not significantly affect cost variation, interestingly there was a negative beta coefficient (beta coefficient -.063. Where the ROTEM test was the single largest cost contributor to anesthesia costs this suggests the ROTEM may be ultimately cost savings. Conclusion: We demonstrate that there is significant cost variation in AVR, and that the major drivers are the use of fibrinogen; the use of blood products; and the choice of valve prosthesis. These costs are arguably both patient and practitioner driven. Interestingly the use of diagnostic ROTEM tests may mitigate costs through more directed strategies toward controlling bleeding. Identification of drivers of cost variation may allow for future cost reduction.

Blood fibrinogen levels discriminate low- and high-risk intraductal papillary mucinous neoplasms (IPMNs)

BackroundThe risk assessment of intraductal papillary mucinous neoplasms (IPMN) to either guide patients to surgical resection or watchful waiting is still under debate. Additional markers to better separate low and high-risk lesions would improve patient selection. MethodsPatients who underwent pancreatic resections for IPMNs between January 2008 and December 2012 with available blood samples were selected and retrospectively assessed. Data on cyst characteristics such as cyst size, duct relation and main-duct dilatation were collected and plasma fibrinogen levels were measured. ResultsA total of 73 patients fulfilled the inclusion criteria by pancreatic resection for pathologically confirmed IPMN and available blood sample. Histologically, IPMNs were classified as low-grade and borderline in 52 (71.2%, group 1) and as high-grade and invasive in 21 (28.8%, group 2) of all cases. Fibrinogen levels showed significant differences between the two groups (group 1: mean 3.62 g/L (SD ± 1.14); group 2: mean 4.49 g/L (SD ± 1.57); p = 0.027). A ROC-curve analysis calculated cut-off value of 4.71 g/L separated groups 1 and 2 (p = 0.008). Fibrinogen levels remained as the only significant factor in multivariable analysis, cyst size and duct relation were not significant. ConclusionBlood fibrinogen differed between low and high risk IPMNs and therefore, the use of fibrinogen as an additional discriminator in the pre-operative risk assessment of IPMNs should be further evaluated.

Post-authorization safety study of Clottafact® , a triply secured fibrinogen concentrate in congenital afibrinogenemia. A prospective observational study.

A new fibrinogen concentrate Clottafact® was developed according to European guidelines on plasma-derived products. A post-authorization safety study was set up in 2009 as part of the risk management plan. This was a non-interventional, prospective, non-comparative, multicenter study of the use of fibrinogen concentrate for congenital afibrinogenemia in real-life medical practice in France. The analysis was descriptive and performed on 3 subgroups: prophylaxis vs. on-demand treatment, age (<6, <12 and ≥12) and severity of the deficiency. Fourteen patients [1-78years] were included in 7 centres and followed for 1year. Twenty-one adverse drug reactions (ADRs) classically reported with fibrinogen (pallor, chills, cough, vomiting, headache, urticaria and erythematous rash) were reported in 5 of 14 patients. Two ADRs were serious: an anaphylactic shock and a subclavian venous thrombosis with a favourable outcome without sequelae. In the nine patients under prophylaxis, 365 of 367 infusions were considered as successful (99·5%) and 2 as failures. For the five patients treated on-demand, the efficacy was rated as excellent for 27 of 48 infusions and good for the 21 others. This study confirms that the benefit/risk balance for this fibrinogen concentrate is favourable.