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Presentation Details
| The Effect of Fibrinogen Concentrate on Clot Strength in Patients with Congenital and Acquired Fibrinogen Deficiency Suchitra Acharya1, Trupti Mehta Shah2, Cristina Solomon3, Sigurd Knaub3, Claudia Djambas Khayat4, Ashok Roy5, Faheez Mohamed5, Keyvan Karkouti6, Jeannie Callum7, 8, Toshko Lissitchkov9, Flora Peyvandi10, 11. 1Northwell Health, New Hyde Park, NY, USA.2Octapharma USA, Paramus, NJ, USA.3Octapharma AG, Lachen, Switzerland.4Hospital Hôtel Dieu de France, Saint Joseph University, Beirut, Lebanon.5Peritoneal Malignancy Institute, Basingstoke, United Kingdom.6University of Toronto, Toronto, ON, Canada.7Queen’s University, Kingston, ON, Canada.8Kingston Health Sciences Centre, Kingston, ON, Canada.9Specialized Hospital for Active Treatment (SHAT) “Joan Pavel”, Sofia, Bulgaria.10Angelo Bianchi Bonomi Hemophilia and Thrombosis Center, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.11Università degli Studi di Milano, Milan, Italy |
Abstract
Background: Fibrinogen deficiency, whether congenital (CFD) or acquired (AFD) through blood loss, consumption or dilution during surgery, can impair blood clot formation and lead to excessive bleeding. Fibrinogen supplementation may be achieved with human fibrinogen concentrate (HFC) or cryoprecipitate, with the latter widely used in the US. However, HFC offers advantages over cryoprecipitate, including reduced viral transmission risk, standardized fibrinogen concentration, and it can be administered immediately after reconstitution with a lower infusion volume. Objectives: To assess the ability of HFC (Fibryga, Octapharma) to increase clot strength and the efficacy and safety of HFC treatment in patients with CFD or AFD. Methods: This assessment included data from adults and adolescents in two Phase 2 (FORMA-01 and FORMA-05) and two Phase 3 (FORMA-02 and FIBRES) studies (Figure 1). HFC treatment was investigated in patients with CFD in FORMA-01 and FORMA-02, and versus cryoprecipitate in patients with AFD undergoing complex abdominal surgery in FORMA-05 and cardiac surgery with cardiopulmonary bypass in FIBRES. In patients with CFD, clot strength was assessed by measuring the change in maximum clot firmness, determined using rotational thromboelastometry (ROTEM), from baseline to 1 hour after HFC infusion. In patients with AFD, clot strength was assessed by ROTEM analysis of FIBTEM A10 or A20 values before and after infusion of the first HFC or cryoprecipitate dose. Hemostatic efficacy was assessed in FORMA-02 and FORMA-05 by the Independent Data Monitoring & Endpoint Adjudication Committee (IDMEAC) using objective 4-point scales, with treatment ‘success’ defined as hemostatic efficacy of ‘good’ or ’excellent’. In FIBRES, the primary efficacy outcome was allogeneic blood products transfused in the 24 h after termination of cardiopulmonary bypass. Safety was assessed across all studies by monitoring treatment-emergent adverse events. Results: This assessment included 47 patients with CFD from FORMA-01 (N=22) and FORMA-02 (N=25), and 780 patients with AFD from FORMA-05 (HFC, n=22; cryoprecipitate, n=23) and FIBRES (HFC, n=372; cryoprecipitate, n=363). Across all four studies, HFC increased mean clot strength (Figure 2). This coincided with hemostatic effectiveness, demonstrated by 100% of patients achieving hemostatic efficacy rated by the IDMEAC as ‘success’ in FORMA-02 (90% confidence interval [CI]: 88.5−100.0%) and FORMA-05 (95% CI: HFC, 83.9−100.0% vs. cryoprecipitate, 84.6−100.0%). In FIBRES, HFC was non-inferior to cryoprecipitate for the primary endpoint (least-squares mean [95% CI] number of units of allogeneic blood products transfused in the 24 h after termination of cardiopulmonary bypass: HFC, 16.3 [14.9–17.8]; cryoprecipitate, 17.0 [15.6–18.6]; p<0.001 for non-inferiority). All four studies demonstrated that HFC had a favorable safety profile. Conclusions: Four Phase 2/Phase 3 trials demonstrated that HFC was effective in increasing clot strength in patients with CFD or AFD, and was hemostatically efficacious and well tolerated. Together with other advantages of HFC over cryoprecipitate, including reduced viral transmission risk, these results advocate the use of HFC in patients with CFD or AFD.
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No part of this publication may be reproduced, distributed, or transmitted in any form or by any means, including photocopying, recording, or other electronic or mechanical methods, without the prior written permission of the author.