A new human fibrinogen concentrate (FIBRYGA®) In paediatric patients undergoing cardiac surgery: first real-world experience based on temporary authorization in France

Introduction The study objective was to describe the conditions of use of FIBRYGA® 1g, a new, highly purified, human fibrinogen concentrate (HFC) in paediatric patients undergoing cardiac surgery. FIBRYGA® has recently been granted a temporary import authorization for use in congenital and acquired fibrinogen deficiencies in France. Methods This was an observational, non-interventional, non-comparative, retrospective study conducted in two French hospital centres using FIBRYGA®. Data from paediatric patients ( Results The analysis included 17 paediatric patients who underwent cardiac surgery. Patients had a history of cardiac disorders (n=3, 17.65%), congenital cardiac disorders (n=11, 64.71%), surgical and medical cardiac procedures (n=2, 11.76%), and tympanosclerosis, cardiac murmur, underweight, renal disorders, pulmonary vascular disorder, or superior vena cava syndrome (n=1, 5.88% for each), Patients were aged between 4 days and 6 years (with the exception of two who were 17) and 12 (70.59%) were male. All patients presented with acquired fibrinogen deficiency requiring administration of HFC. All patients were recorded as given on-demand HFC for bleeding prevention prior to surgery. Mean total dose of HFC was 0.74 ± 0.58 g with a mean of 1.06 ± 0.43 doses per patient. Two patients were given more than one dose, with a mean of 0.65 ± 0.82 hours between doses. The success rate for bleeding prevention was 94.12% (95% CI: 82.93-100.00%]. No patients reported a haemoglobin variation of Discussion The use of FIBRYGA® was associated with favourable efficacy outcomes in paediatric patients undergoing cardiac surgery. The data is comparable to results collected in adult patients (presented separately). This is the first study to date collecting real-world data on the use of FIBRYGA® for managing bleeding in cardiac surgery in a paediatric population with acquired hypofibrigenemia.