Summary
Post-infusion hepatitis is known to occur very frequently in haemophiliacs after treatment
with unheated commercial clotting factor concentrates, obtained from large plasma
donation pool. On the contrary, single-donor cryoprecipitate is likely to carry a
lower risk of transmitting hepatitis.
To evaluate this hypothesis, we retrospectively reviewed the medical records of 25
first infused haemophiliacs (from 1981 to 1984) treated with unheated commercial clotting
factor concentrates (n = 19) or cryoprecipitate (n = 6).
The hepatitis-free interval after the beginning of therapy was expressed as exposure
days. The end point of each patient, i.e. the hepatitis occurrence, was defined as
an increase of aminotransferases (ALT and AST) and/or the seroconversion of HBV-markers,
which were checked every three months.
The life-table method and log-rank test showed that cryo-precipitates had a significantly
longer hepatitis-free interval (p = 0.0131, log-rank test) and a lower risk of transmitting
hepatitis (p = 0.01-0.05, life-table method) than the commercial concentrates. However,
the safety of cryoprecipitate therapy was shown to cover only a few exposure days,
and so the real advantage of this product depends on the bleeding frequency of the
patient concerned.
We believe that these methods and our findings may be useful to assess and compare
the safety of the new “heat-treated” clotting factor concentrates.
Key words
Post-infusion hepatitis - Clotting factor concentrates - Logrank test
