Running head: SYNTHESIS PAPER

Synthesis Paper

Alyssa Blumenthal

University of South Florida
SYNTHESIS PAPER 2
Abstract
Deep vein thrombosis and pulmonary embolism are common after stroke. The
national stroke guidelines recommend the use of graduated compression stockings and
pneumatic compression devices but insufficient evidence exists to show the effectiveness
of either preventative measure. The following randomized control trials assess the
effectiveness of gradual compression stockings versus pneumatic compression devices in
immobile stroke patients over the age of sixty. The objective of this paper is to compare
the effectiveness of gradual compression stockings versus intermittent pneumatic
compression devices in preventing the development of deep vein thrombosis after stroke.
The expected outcome is to implement measures that are more effective thereby reducing
the prevalence of deep vein thrombosis in patients who have experienced stroke and are
immobile. The randomized control trials used in this trial were found using the Google
Scholar search engine and using the key words randomized control trial deep vein
thrombosis prevention in immobile stroke patients. As well as Intermittent pneumatic
compression versus gradual compression prevention of deep vein thrombosis. The trial
suggests that the use of intermittent compression stockings for a patient who has suffered
a stroke and is immobile is effective in reducing the risk of deep vein thrombosis and
possibly improving survival in said patient population while gradual compression
stockings are not as effective and may even promote skin breakdown.

Introduction
According to the Centers for Disease Control and Prevention the exact number of
people affected by deep vein thrombosis (DVT) is unknown (CDC, 2012). However, it
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can be estimated that about one to two people per 1,000 people are affected and as high
as one in one hundred people over the age of eighty are affected each year in the United
States (CDC, 2012). Each year estimates suggest that 60,000 to 100,000 Americans die of
DVT (CDC, 2012). According to a study conducted in 2010 by Pubmed, the total annual
healthcare costs of DVT ranges from ten to fifty-two billion dollars (Mahan, 2011).
Venous thromboembolism is a far too common but avoidable cause of death in
hospitalized patients. Neurosurgical patients who have suffered a stroke and are immobile
are at a very high risk for developing deep vein thrombosis and therefore preventative
measures need to be utilized. Unlike other patients, neurosurgical patients who have
suffered a stroke are often contraindicated for the use of anticoagulants as a preventative
measure. Therefore other preventative measures must be utilized such as intermittent
pneumatic compression devices or gradual compression stockings. The following
randomized control trials examine the effectiveness of both intermittent pneumatic
compression devices and gradual compression stockings and answer the question of
which is more effective in this patients population. Currently the standard of care is for
all patients to utilize intermittent pneumatic compression stockings, during their
hospitalization. However, many patients choose not to use them due to finding them
uncomfortable as well as variety of other personal reasons. Especially on a neurological
floor it is vital that patients who have suffered a stroke and are immobile are using
intermittent pneumatic compression stockings to reduce their risk of developing deep
vein thrombosis. Studies show that in patients at risk for DVT, between the ages of sixty
and one hundred, have a history of stroke and are immobile, gradual compression
stockings are not as effective as intermittent pneumatic compression devices when used
SYNTHESIS PAPER 4
during the course of their hospitalization and ten days following discharge. It should also
be noted that gradual compression stockings were shown to have increased instances of
skin breakdown, ulcers and necrosis. Answering how the use of gradual compression
stockings compared to intermittent pneumatic compression devices affect prevalence of
deep vein thrombosis in patients aged 60-100 who have suffered a stroke and are
immobile over their hospital stay and up to ten days post discharge will assist health care
providers in providing these patients with the most effective preventative measures.
Literature Search
The search engine used for this study was Google Scholar and the University of
South Florida online database. The key terms used for were randomized control trial
deep vein thrombosis prevention in immobile stroke patients. As well as intermittent
pneumatic compression versus gradual compression prevention of deep vein thrombosis.
Literature Review
The CLOTS 3 trial was a randomized control trial taking place in the UK which
examined almost three thousand immobile stroke patients over the age of sixty and
randomly allocated them intermittent pneumatic compression stockings or no intermittent
pneumatic compression stockings (Dennis, 2013). After approximately seven to ten days
patients had an ultrasound scan of their legs and again at twenty-five to thirty days to
screen for DVTs. It was found that the risk of DVT of 8.5% in those receiving
intermittent pneumatic compression and 12.1% in those who were not receiving
intermittent pneumatic compression- a reduction of about 1 in 3 (Dennis, 2013). See table
1 below for more detailed information regarding the CLOTS 3 trial. It was discovered
through the CLOTS 3 trial that intermittent pneumatic compression devices could help
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60,000 people in the UK, could prevent DVT in 3,000 patients and could save about
1,500 lives each year (Dennis, 2013). Compared to the routine care group only, the
intermittent pneumatic compression group showed a 14% mortality risk reduction (p =
0.042) during the first six months after hospital admission for stroke (Dennis, 2013).
Please see Table 1 for more statistical results of the CLOTS 3 trial. The strengths of this
study are that it accounts for a very prevalent and specific patient population however a
weakness may lie in the fact that due to the average age of the population under study,
many patients may have underlying medical conditions which could contribute to
premature death and thus make it more difficult to analyze the findings. This randomized
control trial was critically appraised and met all criteria for an appropriately conducted
randomized controlled trial. The CLOTS 3 trial found that intermittent pneumatic
compression devices is an effective method in reducing the risk of deep vein thrombosis
and improving the survival rate in a large amount of patients who are immobile after
stroke.
The next randomized control trial uses graduated compression stockings with or
without intermittent pneumatic compression on thirty-seven patients for twelve days
postoperatively. These patients were screened with ultrasound for deep vein thrombosis
and found that the prevalence of deep vein thrombosis was five out of thirty seven
patients. The purpose of this study is that it determines the average prevalence of deep
vein thrombosis in neurosurgical patients and thus identifies the need for an improvement
(Taniguchi, 2009). A weakness in this source is that it does not specify the type of
neurosurgery the patient is receiving and therefore it may not be indicative for stroke
patients. The strength in this source is that it determines the prevalence of DVT in
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neurosurgical patients, which helps to develop a baseline for this research. What this
study found was that the prevalence of DVT of the lower legs was 13.5% (5/37) and
incidence of pulmonary embolism was 60% (3/5) in patients having deep vein
thrombosis. All patients having venous thromboembolism were asymptomatic. In high-
risk patients, VTE prevalence after neurosurgery was high even under mechanical
prophylaxis. Additional pharmacological prophylaxis should be considered for patients
with high risk of VTE (Taniguchi, 2009).
The last study is the CLOTS 1 study. The CLOTS 1 study assessed the
effectiveness of thigh length gradual compression stockings in reducing deep vein
thrombosis after stroke. This study was conducted on 2,518 patients admitted for acute
stroke and who were immobile. This study is identical in nature to CLOTS 3 study (see
first trial) but studies the use of gradual compression stockings rather than the use of
intermittent pneumatic compression stockings. What this study found is that thigh length
gradual compression stockings were not as effective in preventing deep vein thrombosis
and additionally may accelerate skin breakdown in this population leading to ulcers,
blisters and skin necrosis (Dennis, 2009). A strength of this study is that it provides a
straight forward comparison for the use of IPC stockings versus the use of GCS and it
also determined that in some instances, GCS may cause skin breaks, ulcers, blisters and
skin necrosis.
The National Guidelines Clearinghouse identifies clinical guidelines for deep vein
thrombosis, which are aligned with most of the clinical methods in place for diagnosing,
treating/managing and preventing deep vein thrombosis. Currently the National
Guidelines Clearing house lists graduated compression stockings under other treatment
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along with patient education, anticoagulant therapy, surgery and thrombolytic therapy
(NGC, 2010). It should be noted that intermittent pneumatic compression devices were
not listed as a treatment on the National Guidelines Clearinghouse website and should be
due to their success rates. Under risk factors, immobility including bed rest, flight travels
and fractures are listed however stroke is not. It is important to consider stroke as a risk
factor for DVT due to many patients resulting in immobility following a stroke.
Synthesis

In patients sixty to one hundred year of age who have had a stroke and are
immobile, intermittent pneumatic compression devices are shown to reduce the risk of
deep vein thrombosis when compared to graduated compression stockings (Dennis,
2013). Additionally, graduated compression stockings have shown to accelerate skin
breakdown thus leading to ulcers and skin necrosis (Dennis, 2009). Although few studies
exist on this population; they do suggest strong evidence in preventing deep vein
thrombosis using intermittent pneumatic compression devices versus the use of graduated
compression stockings. It may be helpful to find additional randomized control trials to
potentially eliminate gradual compression stockings and transition into mandating
intermittent pneumatic compression devices in the hospital for patients sixty-one hundred
that have suffered a stroke and are immobile. The following evidence was found in each
randomized control trial:
Intermittent pneumatic compression devices could help 60,000 people in the UK, could
prevent DVT in 3,000 patients and could save about 1,500 lives each year (Dennis,
2013). Compared to the routine care group only, the intermittent pneumatic compression
SYNTHESIS PAPER 8
group showed a 14% mortality risk reduction (p = 0.042) during the first six months after
hospital admission for stroke (Dennis, 2013).
Thigh length gradual compression stockings were not as effective in preventing deep
vein thrombosis and additionally may accelerate skin breakdown in this population
leading to ulcers, blisters and skin necrosis (Dennis, 2009).
The prevalence of DVT of the lower legs was 13.5% (5/37) and incidence of pulmonary
embolism was 60% (3/5) in patients having deep vein thrombosis (Taniguchi, 2009).
Clinical Recommendations
The current clinical guidelines for deep vein thrombosis in the hospital are case
by case. Many patients at risk for deep vein thrombosis are on anticoagulants as
prophylactic treatment. However, given that these patients are neurosurgical patients who
have just suffered a stroke, anticoagulants may be contraindicated. At this time, hospitals
are equipped with intermittent pneumatic compression devices and patients that fall in the
appropriate category will have them in their rooms and should be using them.
Unfortunately, the reality is that many patients that should be using intermittent
pneumatic compression devices are not using them for a variety of reasons. Patients often
do not understand the importance of intermittent pneumatic compression stockings or
they find them to be uncomfortable. Given the above findings, it is vital to educate
patients on the value of intermittent pneumatic compression stockings and encourage
their use despite the slight discomfort they may cause certain patients. It may be wise to
attempt to initiate a new hospital policy deeming intermittent pneumatic compression
stockings mandatory for immobile stroke patients between the age of sixty and one
hundred. However, because there are limited randomized controlled trials on this
SYNTHESIS PAPER 9
population, it may make it difficult to initiate. If hospital policy cannot be changed due to
insufficient research, health care providers should be educated on the evidenced based
practice that exists so that they understand the appropriate times to provide their patients
with intermittent pneumatic compression stockings versus gradual compression
stockings. Based on the above findings intermittent pneumatic compression stockings
should be utilized over gradual compression stockings as they are shown to reduce
mortality rate up to 14% (Dennis, 2013). Gradual compression stockings, if utilized
patients should also be monitored for skin breakdown as evidence shows GCS increases
the incidence of skin breakdown (Dennis, 2009). The expected outcome of these clinical
recommendations will be a reduction in the prevalence of deep vein thrombosis for
patients who have experienced a stroke and are immobile which will lead to a reduction
in healthcare costs associated with DVT. If prevalence of deep vein thrombosis in
neurosurgical patients was evaluated again in five to ten years after initiating new clinical
guidelines based on the above evidenced based research, the prevalence would decrease
by one third (Dennis, 2013). For example if five out of thirty-seven patients are affected
as seen in the randomized control Identifying prevalence of DVT in neurosurgical
patients then with the use of intermittent pneumatic compression stockings
approximately three out of thirty seven patients will be affected.





SYNTHESIS PAPER 10
References
Centers for Disease Control and Prevention (CDC) (2012). Deep Vein Thrombosis (
DVT)/Pulmonary Embolism (PE)-Blood Clot Forming in a Vein. Retrieved from
http://www.cdc.gov/ncbddd/dvt/data.html
Dennis, M., Sandercock, P., Reid, J., Graham, C., Forbes, J., & Murray, G. (2013).
Effectiveness of intermittent pneumatic compression in reduction of risk of deep
vein thrombosis in patients who have had a stroke (CLOTS 3): A multicentre
randomised controlled trial. Lancet, 382(9891), 516-524. doi:10.1016/S0140-
6736(13)61050-8
Dennis, M., Sandercock, P., Reid, J., Graham, C., Murray, G., Venables, G., ... Bowler,
G. (2009). Effectiveness of thigh-length graduated compression stockings to
reduce the risk of deep vein thrombosis after stroke (CLOTS trial 1): A
multicentre, randomised controlled trial. Lancet, 373(9679), 1958-1965.
doi:10.1016/S0140-6736(09)60941-7
Mahan , C., Holdsworth, M., Welch, S., Borrego, M., & Spyropoulos, A. (2011).
Deep-Vein thrombosis: a United States cost model for preventable and costly
adverse event. Retrieved from http://www.ncbi.nlm.nih.gov/pubmed/21833446
Taniguchi, S., Fukuda, I., Daitoku, K., Minakawa, M., Odagiri, S., Suzuki, Y., ...
Ohkuma, H. (2009). Prevalence of venous thromboembolism in neurosurgical
patients. Heart & Vessels, 24(6), 425. doi:10.1007/s00380-008-1135-9
National Guideline Clearinghouse (NGC). (2010). Guideline Summary- Deep Vein
Thrombosis.
Retrieved from http://www.guideline.gov/content.aspx?id=35208
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Table 1

Literature Review

Reference Aims Design and
Measures
Sample Outcomes /
statistics
Dennis, M., Sandercock, P., Reid, J., Graham, C.,
Forbes, J., & Murray, G. (2013). Effectiveness of
intermittent pneumatic compression in reduction of risk
of deep vein thrombosis in patients who have had a
stroke (CLOTS 3): A multicentre randomised controlled
trial. Lancet, 382(9891), 516-524. doi:10.1016/S0140-
6736(13)61050-8

Aims to
determine
whether
intermitten
t
pneumatic
compressi
on devices
is an
effective
method in
reducing
prevalence
of deep
vein
thrombosi
s in
immobile
stroke
patients
over the
age of
sixty.
RCT

Measures:
Patient
response
for 6
months.
Compressio
n duplex
ultrasound
given at 7-
10 days and
then again
at 25-30
days.

2,876
patients
enrolled
in 94
centers in
the
United
Kingdom
with a
median
age of
76. Each
patient
was
randomly
allocated
to
receive
IPC or no
IPC


The results of
this trial showed
that IPC is an
effective method
of reducing the
risk of DVT and
possibly
improving
survival in a
wide variety of
patients who are
immobile after
stroke. The
Intermittent
pneumatic
compression
group showed a
14% mortality
risk reduction (p
= 0.042) during
the first six
months after
hospital
admission for
stroke (Dennis,
2013).

Taniguchi, S., Fukuda, I., Daitoku, K., Minakawa, M.,
Odagiri, S., Suzuki, Y., ... Ohkuma, H. (2009).
Prevalence of venous thromboembolism in
neurosurgical patients. Heart & Vessels, 24(6), 425.
doi:10.1007/s00380-008-1135-9

Aims to
determine
the
prevalence
of venous
thromboe
mbolism
in
neurosurgi
cal
patients.
RCT

Measures:
The
prevalence
of venous
thromboem
bolism in
patients
receiving
standard
thrombopro
phylaxis
using
graded
compressio
n stockings
with or
without
Thirty
seven
patients
were
screened
by
ultrasono
graphy
for 12
days
postopera
tively
from
neurosur
gery.
Found that the
prevalence of
DVT was 5 in 37
patients and the
presence of
pulmonary
embolism was 3
in 5 patients
having deep vein
thrombosis.
SYNTHESIS PAPER 12
intermittent
pneumatic
compressio
n for twelve
days
postoperati
vely.
Dennis, M., Sandercock, P., Reid, J., Graham, C.,
Murray, G., Venables, G., ... Bowler, G. (2009).
Effectiveness of thigh-length graduated compression
stockings to reduce the risk of deep vein thrombosis
after stroke (CLOTS trial 1): A multicentre, randomised
controlled trial. Lancet, 373(9679), 1958-1965.
doi:10.1016/S0140-6736(09)60941-7


Aims to
assess the
effectiven
ess of
thigh
lengthed
gradual
compressi
on
stockings
to reduce
deep vein
thrombosi
s after
stroke.
RCT

Measures:
The
prevalence
of DVT in
immobile
stroke
patients.
2,518
patients
who
were
admitted
the
hospital
for acute
stroke
and who
were
immobile
following
the
stroke
Found that the
use of thigh-
length gradual
compression
stockings in
patients
hospitalized with
acute stroke was
not effective in
preventing deep
vein thrombosis.