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Frequent off-label use of fondaparinux in patients with suspected acute heparin-induced thrombocytopenia (HIT)--findings from the GerHIT multi-centre registry study.
[heparin-induced thrombocytopenia]
In
life-threatening
immune
heparin-induced
thrombocytopenia
(
HIT
)
,
treatment
with
an
approved
non-heparin
anticoagulant
is
essential
.
However
,
off-label
use
with
fondaparinux
has
been
reported
in
the
literature
.
The
study
aim
was
to
collect
data
on
"
real-life
"
management
of
patients
with
suspected
acute
HIT
regarding
diagnostic
and
therapeutic
strategies
.
In
a
national
multi-centre
registry
study
,
patients
with
a
4
T
's
HIT
-probability
score
of
≥
4
points
and
treatment
with
at
least
one
dose
of
(
A
)
rgatroban
,
(
L
)
epirudin
,
(
D
)
anaparoid
,
or
(
F
)
ondaparinux
were
retrospectively
evaluated
.
Of
195
patients
,
the
4
T
's
scores
were
4
/
5
/
6
/
7
/
8
points
in
46
(
23
.
6
%
)
/
50
(
25
.
6
%
)
/
74
(
38
.
0
%
)
/
13
(
6
.
7
%
)
/
7
(
3
.
6
%
)
patients
,
respectively
.
During
heparin
therapy
,
47
(
24
.
1
%
)
thromboembolic
events
,
5
(
2
.
6
%
)
skin
lesions
,
1
(
0
.
5
%
)
amputation
,
24
(
12
.
3
%
)
Hb-relevant
bleedings
,
and
2
(
1
.
0
%
)
fatalities
occurred
.
A
functional
heparin-induced
platelet
activation
assay
was
performed
in
96
.
9
%
,
a
platelet
factor
4
/
heparin-dependent
enzyme
immunoassay
in
89
.
2
%
,
a
particle
gel
immunoassay
in
12
.
3
%
,
and
a
serotonin-release
assay
in
none
of
the
patients
.
Argatroban
was
used
in
16
.
4
%
,
lepirudin
in
2
.
1
%
,
danaparoid
in
23
.
6
%
,
fondaparinux
in
40
.
0
%
of
the
patients
;
the
sequential
therapy
strata
were
:
AF
(
5
.
6
%
)
,
DA
(
5
.
6
%
)
,
DF
(
2
.
6
%
)
,
DL
(
2
.
1
%
)
,
ADF
(
1
.
5
%
)
,
and
DFL
(
0
.
5
%
)
.
The
current
diagnostic
laboratory
strategy
for
suspected
HIT
is
mostly
(
>
96
%
)
based
on
the
recommended
2
-
step
strategy
(
immunoassay
plus
functional
assay
)
.
However
,
there
is
a
wide
fondaparinux
off-label
use
(
up
to
50
.
3
%
)
for
suspected
HIT
,
even
in
those
patients
with
a
high
clinical
pretest
probability
.
Efficacy
and
safety
of
fondaparinux
for
HIT
-treatment
require
further
evaluation
.
Diseases
Validation
Diseases presenting
"heparin-induced thrombocytopenia"
symptom
heparin-induced thrombocytopenia
This symptom has already been validated