Rare Diseases Symptoms Automatic Extraction
Home
A random Abstract
Our Project
Our Team
A feasible strategy for preventing blood clots in critically ill patients with acute kidney injury (FBI): study protocol for a randomized controlled trial.
[heparin-induced thrombocytopenia]
Previous
pharmacokinetic
trials
suggested
that
40
mg
subcutaneous
enoxaparin
once
daily
provided
inadequate
thromboprophylaxis
for
intensive
care
unit
patients
.
Critically
ill
patients
with
acute
kidney
injury
are
at
increased
risk
of
venous
thromboembolism
and
yet
are
often
excluded
from
these
trials
.
We
hypothesized
that
for
critically
ill
patients
with
acute
kidney
injury
receiving
continuous
renal
replacement
therapy
,
a
dose
of
1
mg
/
kg
enoxaparin
subcutaneously
once
daily
would
improve
thromboprophylaxis
without
increasing
the
risk
of
bleeding
.
In
addition
,
we
seek
to
utilize
urine
output
prior
to
discontinuing
dialysis
,
and
low
neutrophil
gelatinase-associated
lipocalin
in
dialysis-free
intervals
,
as
markers
of
renal
recovery
.
In
a
multicenter
,
double
-blind
randomized
controlled
trial
in
progress
at
three
intensive
care
units
across
Denmark
,
we
randomly
assign
eligible
critically
ill
adults
with
acute
kidney
injury
into
a
treatment
(
1
mg
/
kg
enoxaparin
subcutaneously
once
daily
)
or
control
arm
(
40
mg
enoxaparin
subcutaneously
once
daily
)
upon
commencement
of
continuous
renal
replacement
therapy
.
We
calculated
that
with
133
patients
in
each
group
,
the
study
would
have
80
%
power
to
show
a
40
%
reduction
in
the
relative
risk
of
venous
thromboembolism
with
1
mg
/
kg
enoxaparin
,
at
a
two
-sided
alpha
level
of
0
.
05
.
An
interim
analysis
will
be
conducted
after
the
first
67
patients
have
been
included
in
each
group
.
Enrolment
began
in
March
2013
,
and
will
continue
for
two
years
.
The
primary
outcome
is
the
occurrence
of
venous
thromboembolism
.
Secondary
outcomes
include
anti-
factor
Xa
activity
,
bleeding
,
heparin-induced
thrombocytopenia
,
filter
lifespan
,
length
of
stay
,
ventilator
free
days
,
and
mortality
.
We
will
also
monitor
neutrophil
gelatinase-associated
lipocalin
and
urine
volume
to
determine
whether
they
can
be
used
as
prognostic
factors
for
renal
recovery
.
Critically
ill
unit
patients
with
acute
kidney
injury
present
a
particular
challenge
in
the
provision
of
thromboprophylaxis
.
This
study
hopes
to
add
to
the
growing
evidence
that
the
existing
recommendation
of
40
mg
enoxaparin
is
inadequate
and
that
1
mg
/
kg
is
both
safe
and
effective
for
thromboprophylaxis
.
In
addition
,
the
study
seeks
to
identify
predictors
of
renal
recovery
allowing
for
the
proper
utilization
of
resources
.
EU
Clinical
Trials
Register
:
EudraCT
number
:
2012
-
004368
-
23
,
25
September
2012
.
Diseases
Validation
Diseases presenting
"increased risk of venous thromboembolism"
symptom
heparin-induced thrombocytopenia
You can validate or delete this automatically detected symptom
Validate the Symptom
Delete the Symptom