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The risk of thromboembolism with FIX replacement therapy remains a concern for hemophilic B patients. Previous studies from our laboratory demonstrated that the activated factor content of the FIX Plasma Derived (FIXpd) manufactured at UNC-Hemoderivados was negligible by in vitro assay. Despite this, we considered it important to conduct studies to assess the potential thrombogenic risk of our FIXpd concentrates using a modified stasis animal model.  FIXpd were inject doses of 100 or 200 IU F IX kg-1 and some samples were supplemented with heparin (&lt;0.5 of heparin/ IU FIX). Eight rats were tested at each dose level in the presence or absence of heparin, considering those samples with a thrombogenicity ≥2.0 as of potential thrombogenic risk.  The mean scores ± SD 100 and 200 IU kg-1 in the presence or absence of heparin were 0.25±0.06 and 2.25±0.45 and 1.19±0.26 and 2.81±0.40, respectively. At both doses tested of FIXpd in the absence of heparin, there was no significant difference in mean scores (P&lt;0.05).  The encouraging data obtained from these animal experiments and results from in vitro tests, support the low thrombotic risk associated with the FIXpd concentrate manufactured in UNC Hemoderivados.

Assessment of Potential Thrombogenicity in an Animal Model of a Triple Viral Inactivated Factor IX Concentrate Manufactured in Argentina