摘要：
IntroductionThe 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. MethodsThis was an observational, non-interventional, non-comparative, retrospective study conducted in two French hospital centres using FIBRYGA®. Data from paediatric patients (<18 years) with fibrinogen deficiency having received FIBRYGA® between March 2019 and October 2019 were retrieved from medical files. Indications, modalities, efficacy and safety outcomes were recorded. Indications were recorded as bleeding events during cardiac surgery or fibrinogen administration to prevent bleeding during cardiac surgery. Treatment success was defined as control of bleeding or haemoglobin loss <20% for bleeding treatment, and as an absence of major perioperative haemorrhage for pre-surgical prevention. ResultsThe 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 r
欢迎来到三峡大学图书馆！
中文科技期刊
详细信息
