Human Fibrinogen Concentrate (FGTW) in Pediatric Patients With Congenital Fibrinogen Deficiency

Inclusion Criteria: * Signed and dated informed consent form by parents or a legal representative * Age less or equal to 12 years old * Patients with inherited afibrinogenemia or severe inherited hypofibrinogenemia * Negative results on HCG-based pregnancy test for females of childbearing potential (presence of menstruation) Exclusion Criteria: * Dysfibrinogenemia * Acquired fibrinogen deficiency * Suspected present or past anticoagulation inhibitor * Personal history of venous or arterial thrombosis or thromboembolic event * Co-morbidity with other/unrelated coagulopathies * Administration of any fibrinogen concentrate or fibrinogen containing blood product during the last 15 days * Permanent treatment with antithrombotic or anti-platelet agents such as heparins, anti-IIa or anti-Xa agents, aspirin, clopidogrel and NSAIDs.