Potentially Thrombogenic Materials in Factor IX Concentrates

H. S Kingdon; R. L Lundblad; J. J Veltkamp; D. L Aronson

doi:10.1055/s-0038-1647857

Thrombosis and Haemostasis, Table of Contents

Thromb Haemost 1975; 33(03): 617-631
DOI: 10.1055/s-0038-1647857

International Committee on Thrombosis and Haemostasis Task Force

Schattauer GmbH

Potentially Thrombogenic Materials in Factor IX Concentrates^[*]

H. S Kingdon

¹Dental Research Center, and the Departments of Medicine, Biochemistry, and Pathology, University of North Carolina, Chapel Hill, N. C. 27514, USA

²Academisch Ziekenhuis, Leiden, The Netherlands; Bureau of Biologics, Food and Drug Administration, Bethesda, MD 20014, USA

,

R. L Lundblad

¹Dental Research Center, and the Departments of Medicine, Biochemistry, and Pathology, University of North Carolina, Chapel Hill, N. C. 27514, USA

²Academisch Ziekenhuis, Leiden, The Netherlands; Bureau of Biologics, Food and Drug Administration, Bethesda, MD 20014, USA

,

J. J Veltkamp

¹Dental Research Center, and the Departments of Medicine, Biochemistry, and Pathology, University of North Carolina, Chapel Hill, N. C. 27514, USA

²Academisch Ziekenhuis, Leiden, The Netherlands; Bureau of Biologics, Food and Drug Administration, Bethesda, MD 20014, USA

,

D. L Aronson

¹Dental Research Center, and the Departments of Medicine, Biochemistry, and Pathology, University of North Carolina, Chapel Hill, N. C. 27514, USA

²Academisch Ziekenhuis, Leiden, The Netherlands; Bureau of Biologics, Food and Drug Administration, Bethesda, MD 20014, USA

› Author Affiliations

Abstract

Summary

Factor IX concentrates manufactured from human plasma and intended for therapeutic infusion in man have been suspected for some time of being potentially thrombogenic. In the current studies, assays were carried out in vitro and in vivo for potentially thrombogenic materials. It was possible to rank the various materials tested according to the amount of thrombogenic material detected. For concentrates not containing heparin, there was substantial agreement between the in vivo and in vitro assays, with a coefficient of correlation of 0.77. There was no correlation between the assays for thrombogenicity and the antithrombin III content. We conclude that many presently available concentrates of Factor IX contain substantial amounts of potentially thrombogenic enzymes, and that this fact must be considered in arriving at the decision whether or not to use them therapeutically.

Full Text

References

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Potentially Thrombogenic Materials in Factor IX Concentrates[*]

Potentially Thrombogenic Materials in Factor IX Concentrates^[*]