Thromb Haemost 1991; 66(05): 609-613
DOI: 10.1055/s-0038-1646468
Original Article
Schattauer GmbH Stuttgart

Comparison of High Purity Factor IX Concentrates and a Prothrombin Complex Concentrate in a Canine Model of Thrombogenicity

I R MacGregor
1  The National Science Laboratory, Scottish National Blood Transfusion Service, Edinburgh
,
J M Ferguson
2  The Wellcome Surgical Institute, University of Glasgow, Garscube Estate, Glasgow, United Kingdom
,
L F McLaughlin
1  The National Science Laboratory, Scottish National Blood Transfusion Service, Edinburgh
,
T Burnouf
3  The Centre Regional de Transfusion Sanguine de Lille, Lille, France
,
C V Prowse
1  The National Science Laboratory, Scottish National Blood Transfusion Service, Edinburgh
› Author Affiliations
Further Information

Publication History

Received 19 February 1991

Accepted 24 April 1991

Publication Date:
25 July 2018 (online)

Summary

A non-stasis canine model of thrombogenicity has been used to evaluate batches of high purity factor IX concentrates from 4 manufacturers and a conventional prothrombin complex concentrate (PCC). Platelets, activated partial thromboplastin time (APTT), fibrinogen, fibrin(ogen) degradation products and fibrinopeptide A (FPA) were monitored before and after infusion of concentrate. Changes in FPA were found to be the most sensitive and reproducible indicator of thrombogenicity after infusion of batches of the PCC at doses of between 60 and 180 IU/kg, with a dose related delayed increase in FPA occurring. Total FPA generated after 100-120 IU/kg of 3 batches of PCC over the 3 h time course was 9-12 times that generated after albumin infusion. In contrast the amounts of FPA generated after 200 IU/kg of the 4 high purity factor IX products were in all cases similar to albumin infusion. It was noted that some batches of high purity concentrates had short NAPTTs indicating that current in vitro tests for potential thrombogenicity may be misleading in predicting the effects of these concentrates in vivo.