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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
1   Dental Research Center, and the Departments of Medicine, Biochemistry, and Pathology, University of North Carolina, Chapel Hill, N. C. 27514, USA
2   Academisch Ziekenhuis, Leiden, The Netherlands; Bureau of Biologics, Food and Drug Administration, Bethesda, MD 20014, USA
,
R. L Lundblad
1   Dental Research Center, and the Departments of Medicine, Biochemistry, and Pathology, University of North Carolina, Chapel Hill, N. C. 27514, USA
2   Academisch Ziekenhuis, Leiden, The Netherlands; Bureau of Biologics, Food and Drug Administration, Bethesda, MD 20014, USA
,
J. J Veltkamp
1   Dental Research Center, and the Departments of Medicine, Biochemistry, and Pathology, University of North Carolina, Chapel Hill, N. C. 27514, USA
2   Academisch Ziekenhuis, Leiden, The Netherlands; Bureau of Biologics, Food and Drug Administration, Bethesda, MD 20014, USA
,
D. L Aronson
1   Dental Research Center, and the Departments of Medicine, Biochemistry, and Pathology, University of North Carolina, Chapel Hill, N. C. 27514, USA
2   Academisch Ziekenhuis, Leiden, The Netherlands; Bureau of Biologics, Food and Drug Administration, Bethesda, MD 20014, USA
› Author Affiliations
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Publication History

Received 30 January 1975

accepted 30 January 1975

Publication Date:
24 July 2018 (online)

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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.

* Task Force Report