Efficacy and safety of fibrinogen concentrate for perioperative prophylaxis of bleeding in adult, adolescent, and pediatric patients with congenital fibrinogen deficiency: FORMA‐02 and FORMA‐04 clinical trials

Background Congenital fibrinogen deficiency (CFD) is a rare coagulation disorder placing patients at increased bleeding risk. Human fibrinogen concentrate (HFC) represents current standard of care for fibrinogen replacement in CFD, however, limited data are available on HFC for prophylactic administ...

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Bibliographic Details
Published in:Transfusion (Philadelphia, Pa.) Pa.), 2022-09, Vol.62 (9), p.1871-1881
Main Authors: Khayat, Claudia Djambas, Lohade, Sunil, Zekavat, Omid Reza, Kruzhkova, Irina, Solomon, Cristina, Peyvandi, Flora
Format: Article
Language:English
Subjects:
Adolescent
Adolescents
Adult
Afibrinogenemia - drug therapy
Bleeding
blood component preparations
Blood Loss, Surgical - prevention & control
blood management
Child
Clinical trials
Coagulation
coagulation factor therapy
Disease prevention
Dosage
Effectiveness
Fibrinogen
Fibrinogen - adverse effects
Hemostasis
Hemostatics
Humans
Hydrofluorocarbons
Patients
Pediatrics
Plasma levels
Prophylaxis
Prospective Studies
Safety
Surgery
transfusion practices (adult)
transfusion practices (neonatal, pediatrics)
transfusion practices (surgical)
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Summary:Background Congenital fibrinogen deficiency (CFD) is a rare coagulation disorder placing patients at increased bleeding risk. Human fibrinogen concentrate (HFC) represents current standard of care for fibrinogen replacement in CFD, however, limited data are available on HFC for prophylactic administration before/during surgery. Here, we report results and dosing considerations for HFC treatment in perioperative bleeding management in adult, adolescent, and pediatric patients with CFD. Study Design and Methods FORMA‐02/FORMA‐04 were multinational, prospective, open‐label, uncontrolled Phase 3 HFC efficacy/safety studies for surgical bleeding prophylaxis in adult/adolescent (≥12 years) and pediatric patients (
ISSN:0041-1132
1537-2995
DOI:10.1111/trf.17029