Use of a new human fibrinogen concentrate (FIBRYGA®) In cardiac surgeries: first real-world experience in France based on temporary authorization

Abstract

IntroductionThe objective of the study was to describe the conditions of use of FIBRYGA® 1g, a new, highly purified, human fibrinogen concentrate (HFC) recently granted a temporary import authorization for use in congenital and acquired fibrinogen deficiencies in France.MethodsObservational, non-interventional, non-comparative, retrospective study conducted in 3 French hospital centres using FIBRYGA®. Data from patients with fibrinogen deficiency having received FIBRYGA® from December 2017 to July 2019 were retrieved from their medical files. Indications, modalities, efficacy and safety outcomes were recorded. Indications presented here encompassed bleeding during cardiac surgery (SB) or administration to prevent bleeding during cardiac surgery. Treatment success was defined as control of the bleeding or haemoglobin loss <20% for bleeding treatment and as absence of major perioperative haemorrhage for pre-surgical prevention.ResultsThis analysis included 52 patients who underwent cardiac surgery (aortic dissection repair, aortic surgery, cardiac valvuloplasty, coronary bypass, complex aortic surgery or heart transplantation). Patients were aged 64.9 ± 12.3 years and 69% were male. All presented an acquired fibrinogen deficiency requiring administration of HFC. Indications were SB (n=26, 50%) and prevention of SB (n=26, 50%). Mean total doses of HFC were 1.85 ± 0.97 g for SB and 2.27 ± 1.37 g for prevention of SB. Success rates were 100% (95% confidence interval [CI] 100 -100%] and 92.3% [95%CI 82.1-100%] respectively. Overall tolerance was good.DiscussionThe use of FIBRYGA® was associated with favourable efficacy outcomes in cardiac surgery. As recently shown in a randomized control trial, these real-world data supported the place of HFC as an alternative from cryoprecipitate for the management of bleedings in patients with acquired hypofibrigenemia in cardiac surgery. The objective of the study was to describe the conditions of use of FIBRYGA® 1g, a new, highly purified, human fibrinogen concentrate (HFC) recently granted a temporary import authorization for use in congenital and acquired fibrinogen deficiencies in France. Observational, non-interventional, non-comparative, retrospective study conducted in 3 French hospital centres using FIBRYGA®. Data from patients with fibrinogen deficiency having received FIBRYGA® from December 2017 to July 2019 were retrieved from their medical files. Indications, modalities, efficacy and safety outcomes were recorded. Indications presented here encompassed bleeding during cardiac surgery (SB) or administration to prevent bleeding during cardiac surgery. Treatment success was defined as control of the bleeding or haemoglobin loss <20% for bleeding treatment and as absence of major perioperative haemorrhage for pre-surgical prevention. This analysis included 52 patients who underwent cardiac surgery (aortic dissection repair, aortic surgery, cardiac valvuloplasty, coronary bypass, complex aortic surgery or heart transplantation). Patients were aged 64.9 ± 12.3 years and 69% were male. All presented an acquired fibrinogen deficiency requiring administration of HFC. Indications were SB (n=26, 50%) and prevention of SB (n=26, 50%). Mean total doses of HFC were 1.85 ± 0.97 g for SB and 2.27 ± 1.37 g for prevention of SB. Success rates were 100% (95% confidence interval [CI] 100 -100%] and 92.3% [95%CI 82.1-100%] respectively. Overall tolerance was good. The use of FIBRYGA® was associated with favourable efficacy outcomes in cardiac surgery. As recently shown in a randomized control trial, these real-world data supported the place of HFC as an alternative from cryoprecipitate for the management of bleedings in patients with acquired hypofibrigenemia in cardiac surgery.