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Current in vitro tests for thrombogenicity of FIX concentrates used for prothrombin complex concentrates (PCCs), are of little value when applied to high purity FIX (HP FIXs). In the present study, we have developed a chromogenic assay for activated FIX (FIXa) and evaluated its ability to predict in vivo thrombogenic potential of HP FIXs in a modified Wessler stasis model. Among the HP FIXs, only 1 out of 7 products had no detectable FIXa; this product also showed no in vivo thrombogenicity. In the other 6 products, FIXa content ranged from 0.15-1.2 U/1000 in FIX, and all showed some evidence of in vivo thrombogenicity, with mean thrombus scores ranging from 0.25-4. There was a significant positive correlation (r = 0.55, p < 0.02) between FIXa levels and in vivo thrombogenicity of HP FIXs. NAPTT data were not significantly correlated with the in vivo results and the TFCT also showed no direct correlation with the mean thrombus score. These results indicate that HP FIXs may still carry a small residual thrombotic risk and measurement of FIXa content of these products may be a better predictor of thrombogenicity than the current in vitro tests.
E Gray, and
J Tubbs, and
S Thomas, and
A Oates, and
M Boisclair, and
G Kemball-Cook, and
T W Barrowcliffe
January 1995,
Haemophilia : the official journal of the World Federation of Hemophilia,
E Gray, and
J Tubbs, and
S Thomas, and
A Oates, and
M Boisclair, and
G Kemball-Cook, and
T W Barrowcliffe
January 1995,
Haemophilia : the official journal of the World Federation of Hemophilia,
E Gray, and
J Tubbs, and
S Thomas, and
A Oates, and
M Boisclair, and
G Kemball-Cook, and
T W Barrowcliffe
July 1991,
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E Gray, and
J Tubbs, and
S Thomas, and
A Oates, and
M Boisclair, and
G Kemball-Cook, and
T W Barrowcliffe
October 1977,
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E Gray, and
J Tubbs, and
S Thomas, and
A Oates, and
M Boisclair, and
G Kemball-Cook, and
T W Barrowcliffe
February 1979,
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E Gray, and
J Tubbs, and
S Thomas, and
A Oates, and
M Boisclair, and
G Kemball-Cook, and
T W Barrowcliffe
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E Gray, and
J Tubbs, and
S Thomas, and
A Oates, and
M Boisclair, and
G Kemball-Cook, and
T W Barrowcliffe
August 1977,
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E Gray, and
J Tubbs, and
S Thomas, and
A Oates, and
M Boisclair, and
G Kemball-Cook, and
T W Barrowcliffe
January 1980,
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E Gray, and
J Tubbs, and
S Thomas, and
A Oates, and
M Boisclair, and
G Kemball-Cook, and
T W Barrowcliffe
November 1975,
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E Gray, and
J Tubbs, and
S Thomas, and
A Oates, and
M Boisclair, and
G Kemball-Cook, and
T W Barrowcliffe
June 1975,
Thrombosis et diathesis haemorrhagica,
