The FDA Letter to Doctors stated that using albumin and plasma protein
fraction (PPF) caused increased mortality of approximately 6%, and
therefore albumin and PPF should be used with caution.
As I recall from the poster presentation of the Hextend clinical trial
data, the Hextend patients required less "blood products", including
fresh frozen plasma (FFP).
I don't know whether fresh frozen plasma (FFP) is the same thing as
plasma protein fraction (PPF), and whether, if you take PPF and freeze
it, you get FFP.
Certainly, both are blood products whether in the liquid or the solid
state, and use of both has been called into question by the FDA. And,
during the Hextend clinical trials, blood products of all types were
used if the doctors determined that was best for their patients. To my
knowledge, there was no restriction or exclusion placed on use of any
particular class of blood product (e.g. PPF) if the doctor treating a
patient thought that patient required it.
If you want more info than is presented in the poster paper on the
comparative advantage of Hextend versus Hespan, read the paper reporting
the results of the clinical trails when it comes out, probably around
the end of this year. This paper is presently being peer reviewed. Or,
if you are a shareholder, go visit BioTime and look at the data first
hand.
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